Science.gov

Sample records for fda presentation slides

  1. [Heritage Education Lesson Plans and Slide Presentations].

    ERIC Educational Resources Information Center

    Van Buren, Maurie

    Field tested in 27 schools and in grades four through twelve, this teaching unit stresses heritage education through the study of southern U.S. architectural styles for homes from the pioneer log structures to the 1950s ranch home. Each of the four lessons in this unit focuses around a slide presentation of 20 slides designed to fit into one…

  2. SSP: Sketching Slide Presentations, a Syntactic Approach

    NASA Astrophysics Data System (ADS)

    Mas, Joan; Sanchez, Gemma; Lladós, Josep

    The design of a slide presentation is a creative process. In this process first, humans visualize in their minds what they want to explain. Then, they have to be able to represent this knowledge in an understandable way. There exists a lot of commercial software that allows to create our own slide presentations but the creativity of the user is rather limited. In this article we present an application that allows the user to create and visualize a slide presentation from a sketch. A slide may be seen as a graphical document or a diagram where its elements are placed in a particular spatial arrangement. To describe and recognize slides a syntactic approach is proposed. This approach is based on an Adjacency Grammar and a parsing methodology to cope with this kind of grammars. The experimental evaluation shows the performance of our methodology from a qualitative and a quantitative point of view. Six different slides containing different number of symbols, from 4 to 7, have been given to the users and they have drawn them without restrictions in the order of the elements. The quantitative results give an idea on how suitable is our methodology to describe and recognize the different elements in a slide.

  3. Web-Based Slide Presentations.

    ERIC Educational Resources Information Center

    Just, Melissa L.

    At the University of Southern California's Norris Medical Library, seminars on World Wide Web topics are given to faculty, staff, students, and to community health care providers at remote sites. The presentations have been given using presentation software such as Microsoft PowerPoint, while running Netscape in the background, switching between…

  4. Global Trends in Environment and Development. Presentation Set [Slides].

    ERIC Educational Resources Information Center

    World Resources Inst., Washington, DC.

    This 50 slide set of presentation graphs and maps illustrates some of the major conditions and trends in population, agriculture, biodiversity, forests, water resources, energy, climate, and social and economic development that determine the state of the world's environment. Graphs and maps can be used by those in academic, professional, and…

  5. The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.

    PubMed

    Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

    2016-07-01

    The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing. PMID:27116022

  6. The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.

    PubMed

    Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

    2016-07-01

    The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.

  7. Optimizing Student Learning: Examining the Use of Presentation Slides

    ERIC Educational Resources Information Center

    Strauss, Judy; Corrigan, Hope; Hofacker, Charles F.

    2011-01-01

    Sensory overload and split attention result in reduced learning when instructors read slides with bullet points and complex graphs during a lecture. Conversely, slides containing relevant visual elements, when accompanied by instructor narration, use both the visual and verbal channels of a student's working memory, thus improving the chances of…

  8. Discourse for slide presentation: An overview of chemical detection systems

    NASA Technical Reports Server (NTRS)

    Peters, Randy Alan; Galen, Theodore J.; Pierson, Duane L.

    1990-01-01

    A brief overview of some of the analytical techniques currently used in monitoring and analyzing permanent gases and selected volatile organic compound in air are presented. Some of the analytical considerations in developing a specific method are discussed. Four broad groups of hardware are discussed: compound class specific personal monitors, gas chromatographic systems, infrared spectroscopic systems, and mass spectrometric residual gas analyzer systems. Three types of detectors are also discussed: catalytic sensor based systems, photoionization detectors, and wet or dry chemical reagent systems. Under gas chromatograph based systems five detector systems used in combination with a GC are covered: thermal conductivity detectors, photoionization detectors, Fourier transform infrared spectrophotometric systems, quadrapole mass spectrometric systems, and a relatively recent development, a surface acoustic wave vapor detector.

  9. Slide Presentations as Speech Suppressors: When and Why Learners Miss Oral Information

    ERIC Educational Resources Information Center

    Wecker, Christof

    2012-01-01

    The objective of this study was to test whether information presented on slides during presentations is retained at the expense of information presented only orally, and to investigate part of the conditions under which this effect occurs, and how it can be avoided. Such an effect could be expected and explained either as a kind of redundancy…

  10. An Experiment to Determine the Effectiveness of Slides and Audio-Tapes for Presenting Manipulative Demonstrations in Graphic Arts.

    ERIC Educational Resources Information Center

    Jenkins, John David

    This study compared teacher demonstrations with a slide-tape methods of presenting demonstrations in graphic arts. It involved 134 eighth grade students and four teachers in four schools. Random assignment to treatments was made by classes. Four demonstrations randomly selected from a group were (1) composing a line of type, (2) locking-up a type…

  11. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

  12. FDA 101: Dietary Supplements

    MedlinePlus

    ... professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, ... the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports ...

  13. Slide-free histology via MUSE: UV surface excitation microscopy for imaging unsectioned tissue (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Levenson, Richard M.; Harmany, Zachary; Demos, Stavros G.; Fereidouni, Farzad

    2016-03-01

    Widely used methods for preparing and viewing tissue specimens at microscopic resolution have not changed for over a century. They provide high-quality images but can involve time-frames of hours or even weeks, depending on logistics. There is increasing interest in slide-free methods for rapid tissue analysis that can both decrease turn-around times and reduce costs. One new approach is MUSE (microscopy with UV surface excitation), which exploits the shallow penetration of UV light to excite fluorescent signals from only the most superficial tissue elements. The method is non-destructive, and eliminates requirement for conventional histology processing, formalin fixation, paraffin embedding, or thin sectioning. It requires no lasers, confocal, multiphoton or optical coherence tomography optics. MUSE generates diagnostic-quality histological images that can be rendered to resemble conventional hematoxylin- and eosin-stained samples, with enhanced topographical information, from fresh or fixed, but unsectioned tissue, rapidly, with high resolution, simply and inexpensively. We anticipate that there could be widespread adoption in research facilities, hospital-based and stand-alone clinical settings, in local or regional pathology labs, as well as in low-resource environments.

  14. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  15. Beyond biotechnology: FDA regulation of nanomedicine.

    PubMed

    Miller, John

    2003-01-01

    Nanotechnology, which involves investigating and manipulating matter at the atomic and molecular levels, may radically transform industry and society. Because nanotechnology could introduce whole new classes of materials and products, it could present an array of novel challenges to regulatory agencies. In this note, John Miller explores the regulatory challenges facing the Food and Drug Administration in regulating nanomedical products. First, the FDA will have trouble fitting the products into the agency's classification scheme. Second, it will be difficult for the FDA to maintain adequate scientific expertise in the field. He concludes that the FDA should consider implementing several reforms now to ensure that it is adequately prepared to regulate nanomedicine.

  16. Automatic Organization and Generation of Presentation Slides for E-Learning

    ERIC Educational Resources Information Center

    Sathiyamurthy, K.; Geetha, T. V.

    2012-01-01

    The effectiveness of an e-learning system for distance education to a large extent depends on the relevancy and presentation of learning content to the learner. The ability to gather documents on a particular topic from the web and adapt the contents of the document to suit the learner is an important task from the content creation perspective of…

  17. Teach Classification with Slides.

    ERIC Educational Resources Information Center

    Franks, Deborah

    1980-01-01

    Described is a creative approach to the use of contact slides as a means of student participation in a learning unit on animal classification. The finished product is a slide presentation in which students themselves have made the slides and taped the narration. (CS)

  18. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

  19. Adaptation of Vocational Education Programs for Special Needs: A Slide/Tape Presentation. Final Report. Research Series Number 62.

    ERIC Educational Resources Information Center

    North Dakota Univ., Grand Forks. Dept. of Home Economics and Nutrition.

    A slide/tape series entitled "Vocational Education and the Special Needs Student" was developed in North Dakota to illustrate adaptations that vocational education teachers have made for special needs students (mentally handicapped, physically handicapped, and disadvantaged) and to serve as a basis for discussion at inservice and preservice levels…

  20. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

    The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…

  1. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  2. Physics in water slides

    NASA Astrophysics Data System (ADS)

    Thomazo, Jean-Baptiste; Reyssat, Etienne; Fermigier, Marc

    2015-11-01

    Water slides are body-size inclined pipes fed with water to improve sliding. Water is allowed to freely flow down the slide. It forms a lubrication film that reduces friction between the slide and the body, allowing sliders to travel down at high speeds. We present the results of an experimental study on a model water slide at the scale of the laboratory. We analyze the sliding velocities of cylindrical objects of various masses and sizes sliding down an inclined gutter fed with a controlled flux of water. In the range of parameters that we have studied, we show that the speed of the model sliders is faster than the flow of the environing water. We propose a minimal model to account for the observed sliding velocities measured in our experiments. The sliding velocity is set by a balance of the apparent weight with inertial drag or viscous friction in the lubrication film under the slider. Other resisting mechanisms will also be discussed.

  3. A case of 46, XY DSD presenting as a crossed ectopic gonad with a contralateral sliding inguinal hernia.

    PubMed

    Fukui, Shinji; Watanabe, Masato; Yoshino, Kaoru

    2012-12-01

    A three-month-old boy was referred to our facility for the treatment of a right impalpable testis, left inguinal hernia, and penoscrotal hypospadias with asymmetric external genitalia. The left gonad was palpated in the left scrotum. The chromosomal study revealed a normal male 46, XY karyotype. Operative findings showed that the right streak gonad, uterus, and fallopian tubes were in the wall of the left hernia sac, forming a sliding hernia. Laparoscopy confirmed that the right gonadal vessels had crossed to the left internal inguinal ring. Herniorrhaphy was done and the right streak gonad, uterus, and fallopian tubes were excised. An exploration of the left gonad revealed an ovotestis. The ovary was removed, and a left testicular biopsy was simultaneously performed. A one-stage hypospadias repair using Koyanagi procedure was also performed. The pathological findings showed an ovarian stroma in the right gonad and left ovary. Only Sertoli cells were detected in the biopsied specimen from the left testis. PMID:23217900

  4. Mini Lessons from FDA.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHEW), Washington, DC.

    Eight self-contained lessons present information about topics of current interest in the Food and Drug Administration. Multidisciplinary in nature, the lessons can be integrated into ongoing activities in elementary or secondary level reading, math, language arts, social studies, science, art, health, consumer education, and home economics. The…

  5. FDA's perspectives on cardiovascular devices.

    PubMed

    Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

    2009-06-01

    The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

  6. Slide system for machine tools

    DOEpatents

    Douglass, Spivey S.; Green, Walter L.

    1982-01-01

    The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

  7. Slide system for machine tools

    DOEpatents

    Douglass, S.S.; Green, W.L.

    1980-06-12

    The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

  8. FDA's planning for radiological emergencies

    SciTech Connect

    Swick, C.

    1981-01-01

    The Three Mile Island accident pointed out a number of shortcomings in federal and state governmental planning for radiological emergencies. One concerns the handling of radiation-contaminated food. Pennsylvania, for example, has no legal limits for the amount of radionuclides permitted in food. An examination of the Food and Drug Administration's (FDA's) guidelines for the control of radiation-contaminated food which may be sold in interstate commerce concludes that only the Food, Drug and Cosmetic Act and one provision of the Atomic Energy Act are applicable; that the adulterated food section of the Act is not an effective means of barring the food from interstate commerce; and that the FDA has not established any regulations allowing it to condemn such food as required by the Act. 98 references.

  9. FDA Warns About Stem Cell Claims

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA Warns About Stem Cell Claims Share Tweet Linkedin Pin it More sharing ... blood-forming system. back to top Regulation of Stem Cells FDA regulates stem cells in the U.S. to ...

  10. FDA Approves New Weight-Loss Device

    MedlinePlus

    ... gov/news/fullstory_159362.html FDA Approves New Weight-Loss Device Surgically implanted port allows obese patients to ... have been unable to lose weight and maintain weight loss using nonsurgical treatments. The FDA approval is for ...

  11. Water-slide alopecia.

    PubMed

    Adams, B B

    2001-05-01

    A 29-year-old male presented with large, symmetric, alopecic patches on the posterolateral aspects of both calves. A detailed history revealed that the individual had recently attended a water-slide amusement park. Repeated frictional trauma between the legs and the slide resulted in these alopecic patches. Friction, especially when encountered during sports-related and recreational activities, should be included in the differential diagnosis of well-defined alopecic patches.

  12. Internet Database Review: The FDA BBS.

    ERIC Educational Resources Information Center

    Tomaiuolo, Nicholas G.

    1993-01-01

    Describes the electronic bulletin board system (BBS) of the Food and Drug Administration (FDA) that is accessible through the Internet. Highlights include how to gain access; the menu-driven software; other electronic sources of FDA information; and adding value. Examples of the FDA BBS menu and the help screen are included. (LRW)

  13. Philip Morris' FDA gambit: good for public health?

    PubMed

    Givel, Michael

    2005-12-01

    The objective of this study was to determine whether the 2004 USA Dewine-Kennedy Bill is congruent with Philip Morris' core policy principles for United States Food and Drug Administration (FDA) regulation of tobacco and what impact that would have on the public health. I compared the Dewine-Kennedy Bill with 1999 Philip Morris core policy principles for FDA regulation. Additional supporting data on FDA regulation from 1998 to the present were collected from previously secret tobacco industry documents, relevant newspaper reports from Nexis-Lexis, federal statutes, and federal regulations. The main outcome measure of the study is a comparison, summary, and analysis of the Dewine-Kennedy Bill with Philip Morris' core principles for FDA regulation, and the result is that the Dewine-Kennedy Bill is compatible with almost all of Philip Morris' core principles on FDA regulation. In conclusion, The Dewine-Kennedy Bill, at best, was mixed in terms of the enhancement of the public health. On the one hand, proponents of this legislation argued stronger FDA regulatory requirements would have some effect on reducing youth and adult tobacco consumption. On the other hand, tobacco products would have remained a politically and economically viable and legal product consumed by millions of Americans many of whom would have continued to suffer from tobacco-related illnesses and deaths.

  14. Doctors, drugs, and the FDA.

    PubMed

    Shanklin, D R

    1972-11-01

    This communication is directed to obstetricians, to the Food and Drug Administration (FDA), and to those individuals who might want to impose possibly unnecessary external structures on the practice of medicine. It is considered a positive that the patients of today are well informed and are more actively participating in therapeutic design. There is more veto power on the part of the patient and more concern over the trained ability of the physician. In the past physicians frequently made judgements individually, applying isolated and at times random standards for their decisions. Such actions were inevitable in an era when neither pathogenesis nor treatment was well understood. Now there is no excuse for such actions. Communication is easy, journals are widely circulated, and there are numerous refresher seminars. Increased specialization of knowledge has meant more corporate or group decisions for therapy. Current trends will continue to offer both opportunities and responsibilities. The opportunities are for better diffusion of knowledge, and the responsibility is to be informed. There can be a high level national standard for medical practice. As a beginning, the medical practice laws could use some uniform decisions. The FDA needs to show more responsiveness to changing knowledge and increased willingness to reconsider indications and contraindications in the light of newer experience. There is sufficient information available now to support the revocation of the approval of the use of diuretics in the management of human pregnancy. Another role of the FDA is the approval of new substances or new uses of old substances. The prostaglandins appear in this category, and the December 1972 issue will include the recent Brook Lodge Symposium on prostaglandins. The individual physician requires journal articles, individual experience, and designed trials in order to make judgements on patients who may have some factors not accounted for by groupthink or regulations

  15. Appearance Normalization of Histology Slides

    NASA Astrophysics Data System (ADS)

    Niethammer, Marc; Borland, David; Marron, J. S.; Woosley, John; Thomas, Nancy E.

    This paper presents a method for automatic color and intensity normalization of digitized histology slides stained with two different agents. In comparison to previous approaches, prior information on the stain vectors is used in the estimation process, resulting in improved stability of the estimates. Due to the prevalence of hematoxylin and eosin staining for histology slides, the proposed method has significant practical utility. In particular, it can be used as a first step to standardize appearances across slides, that is very effective at countering effects due to differing stain amounts and protocols, and to slide fading. The approach is validated using synthetic experiments and 13 real datasets.

  16. Access to F.D.A. Information.

    ERIC Educational Resources Information Center

    Sinovic, Dianna

    Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

  17. Current FDA directives for promoting public health

    SciTech Connect

    Hayes, A.H. Jr.

    1982-03-01

    The current directions of the FDA are outlined. The underlying philosophy of the FDA under the Reagan Administration is that both the private sector and the government must address the responsibilities to which they are best suited for the health-care system to work more efficiently. To facilitate this, FDA is conducting comprehensive reviews of FDA regulations and the drug-evaluation process. There are many dimensions to promoting public health, and the FDA alone cannot assure an adequate supply of safe and effective drugs. Innovative science and technology are needed to develop new drugs, followed by maximum potentiation (maximum good and least harm) after FDA approval. Hospital pharmacists have a role in maximizing the potential benefits of drugs through pharmacy and therapeutics committees. The current status of the pilot program for patient package inserts is described. The response at a recent hearing on the program indicates that the responsibility to protect the public health is shared by the government, health professions, industry, and the public. The FDA's campaign on sodium is based on that shared responsibility. By improving communication and building upon their common objections, both pharmacy and the FDA can do their jobs successfully.

  18. Appearance normalization of histology slides.

    PubMed

    Vicory, Jared; Couture, Heather D; Thomas, Nancy E; Borland, David; Marron, J S; Woosley, John; Niethammer, Marc

    2015-07-01

    This paper presents a method for automatic color and intensity normalization of digitized histology slides stained with two different agents. In comparison to previous approaches, prior information on the stain vectors is used in the plane estimation process, resulting in improved stability of the estimates. Due to the prevalence of hematoxylin and eosin staining for histology slides, the proposed method has significant practical utility. In particular, it can be used as a first step to standardize appearance across slides and is effective at countering effects due to differing stain amounts and protocols and counteracting slide fading. The approach is validated against non-prior plane-fitting using synthetic experiments and 13 real datasets. Results of application of the method to adjustment of faded slides are given, and the effectiveness of the method in aiding statistical classification is shown.

  19. Planning for effective interaction with FDA.

    PubMed

    Spurgin, Elizabeth A

    2004-12-01

    Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets.

  20. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to improve focus ... 2016 (HealthDay News) -- An implant that helps the aging eye focus on small print and nearby objects ...

  1. Traumatic Brain Injury: FDA Research and Actions

    MedlinePlus

    ... For Consumers Home For Consumers Consumer Updates Traumatic Brain Injury: FDA Research and Actions Share Tweet Linkedin ... top What to Do if You Suspect Traumatic Brain Injury Anyone with signs of moderate or severe ...

  2. FDA Approves First Immunotherapy for Lymphoma

    Cancer.gov

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  3. FDA Warns Ovarian Cancer Tests Not Reliable

    MedlinePlus

    ... medlineplus.gov/news/fullstory_160880.html FDA Warns Ovarian Cancer Tests Not Reliable May delay preventive therapies for ... Sept. 9, 2016 (HealthDay News) -- Screening tests for ovarian cancer are not reliable and should not be used, ...

  4. FDA Bolsters Warnings about Class of Antibiotics

    MedlinePlus

    ... 160078.html FDA Bolsters Warnings About Class of Antibiotics Fluoroquinolones such as Cipro, Levaquin should be reserved ... it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to ...

  5. FDA Expands Advice on Statin Risks

    MedlinePlus

    ... of liver damage. back to top Reports of Memory Loss FDA has been investigating reports of cognitive ... included assessments of cognitive function. The reports about memory loss, forgetfulness and confusion span all statin products ...

  6. Dust Slides

    NASA Technical Reports Server (NTRS)

    2006-01-01

    [figure removed for brevity, see original site] Context image for PIA03677 Linear Clouds

    Dust slides are common in the dust covered region called Lycus Sulci. A large fracture is also visible in this image.

    Image information: VIS instrument. Latitude 28.1N, Longitude 226.3E. 18 meter/pixel resolution.

    Note: this THEMIS visual image has not been radiometrically nor geometrically calibrated for this preliminary release. An empirical correction has been performed to remove instrumental effects. A linear shift has been applied in the cross-track and down-track direction to approximate spacecraft and planetary motion. Fully calibrated and geometrically projected images will be released through the Planetary Data System in accordance with Project policies at a later time.

    NASA's Jet Propulsion Laboratory manages the 2001 Mars Odyssey mission for NASA's Office of Space Science, Washington, D.C. The Thermal Emission Imaging System (THEMIS) was developed by Arizona State University, Tempe, in collaboration with Raytheon Santa Barbara Remote Sensing. The THEMIS investigation is led by Dr. Philip Christensen at Arizona State University. Lockheed Martin Astronautics, Denver, is the prime contractor for the Odyssey project, and developed and built the orbiter. Mission operations are conducted jointly from Lockheed Martin and from JPL, a division of the California Institute of Technology in Pasadena.

  7. Slide Tape. A Guide to the Production of Slide-Tape Programmes.

    ERIC Educational Resources Information Center

    Rowatt, Robert W.

    Step by step instructions are provided for planning and executing a slide tape program, as well as diagrams of equipment for presenting such programs. Guidelines are given for ways to: (1) define a program's purpose and objectives, (2) complete a storyboard, (3) produce slides from transparencies and photographed artwork, (4) write on slides, (5)…

  8. PREFACE: Fractional Differentiation and its Applications (FDA08) Fractional Differentiation and its Applications (FDA08)

    NASA Astrophysics Data System (ADS)

    Baleanu, Dumitru; Tenreiro Machado, J. A.

    2009-10-01

    The international workshop, Fractional Differentiation and its Applications (FDA08), held at Cankaya University, Ankara, Turkey on 5-7 November 2008, was the third in an ongoing series of conferences dedicated to exploring applications of fractional calculus in science, engineering, economics and finance. Fractional calculus, which deals with derivatives and integrals of any order, is now recognized as playing an important role in modeling multi-scale problems that span a wide range of time or length scales. Fractional calculus provides a natural link to the intermediate-order dynamics that often reflects the complexity of micro- and nanostructures through fractional-order differential equations. Unlike the more established techniques of mathematical physics, the methods of fractional differentiation are still under development; while it is true that the ideas of fractional calculus are as old as the classical integer-order differential operators, modern work is proceeding by both expanding the capabilities of this mathematical tool and by widening its range of applications. Hence, the interested reader will find papers here that focus on the underlying mathematics of fractional calculus, that extend fractional-order operators into new domains, and that apply well established methods to experimental and theoretical problems. The organizing committee invited presentations from experts representing the international community of scholars in fractional calculus and welcomed contributions from the growing number of researchers who are applying fractional differentiation to complex technical problems. The selection of papers in this topical issue of Physica Scripta reflects the success of the FDA08 workshop, with the emergence of a variety of novel areas of application. With these ideas in mind, the guest editors would like to honor the many distinguished scientists that have promoted the development of fractional calculus and, in particular, Professor George M

  9. Epidural steroid warning controversy still dogging FDA.

    PubMed

    Manchikanti, Laxmaiah; Candido, Kenneth D; Singh, Vijay; Gharibo, Christopher G; Boswell, Mark V; Benyamin, Ramsin M; Falco, Frank J E; Grider, Jay S; Diwan, Sudhir; Hirsch, Joshua A

    2014-01-01

    On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as

  10. FDA approved drugs as potential Ebola treatments

    PubMed Central

    Ekins, Sean; Coffee, Megan

    2015-01-01

    In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available. PMID:25789163

  11. FDA aprueba la primera inmunoterapia para linfoma

    Cancer.gov

    La FDA ha aprobado nivolumab (Opdivo®) para el tratamiento de pacientes con el linfoma clásico de Hodgkin que ha recaído o empeorado después de recibir un trasplante autólogo hematopoyético seguido de brentuximab vedotin (Adcetris®)

  12. Nods for Atezolizumab and Nivolumab from FDA.

    PubMed

    2016-08-01

    The FDA has conditionally approved atezolizumab, the first PD-L1 inhibitor, for metastatic urothelial carcinoma, along with a companion diagnostic, the Ventana PD-L1 (SP142) assay. The agency has also expanded nivolumab's indications to include classical Hodgkin lymphoma, making this PD-1 inhibitor the first to be approved for a hematologic malignancy.

  13. 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... and Tracing of Food'' that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the... Register of March 5, 2013 (78 FR 14309), FDA published a ] notice with a 30-day comment period to...

  14. Sliding vane geometry turbines

    DOEpatents

    Sun, Harold Huimin; Zhang, Jizhong; Hu, Liangjun; Hanna, Dave R

    2014-12-30

    Various systems and methods are described for a variable geometry turbine. In one example, a turbine nozzle comprises a central axis and a nozzle vane. The nozzle vane includes a stationary vane and a sliding vane. The sliding vane is positioned to slide in a direction substantially tangent to an inner circumference of the turbine nozzle and in contact with the stationary vane.

  15. Instant slides of radiographs for lectures.

    PubMed

    Rothstein, S G; Stewart, P L

    1989-10-01

    High quality slides of radiographs may be made with a simple, fast, and inexpensive technique using Kodak Rapid Process Copy film. Lecture presentations may include a slide of a pertinent plain radiograph, computed tomography (CT) scan, or magnetic resonance imaging (MRI). Although these slides may be made with a 35 mm SLR camera and flash or with a 35 mm SLR camera and a lighted viewbox, an alternative method is available that is easy to perform, inexpensive, and can produce quality slides in as little as 30 minutes. PMID:2477785

  16. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

    Background Cincinnati Children’s Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration’s (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. Methods This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Results Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. Conclusions The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system. PMID:23617267

  17. Avanti overcomes safety concerns raised by FDA.

    PubMed

    1995-02-01

    As an alternative to the latex condom, the Avanti polyurethane condom represents the first technological breakthrough in the condom industry in 70 years. The manufacturer, London International in Florida, claims to have spent $16 million developing this condom. Although the US Food and Drug Administration (FDA) determined that the condom is safe, it questioned test results showing that the polyurethane material did not biodegrade under relatively mild conditions. Therefore, the FDA required the company to perform additional animal toxicity studies, which showed that the product was safe for rabbits. This was necessary because certain polyurethanes when degrading in mild conditions release a known carcinogen and a potential toxin. Canadian officials are also reviewing Avanti for approval; Canada does not have standards for plastic condoms either. The co-inventor of the Avanti condom said in San Diego that the toxicity studies had been conducted to satisfy the FDA, and there were no indications that the polyurethane condom could cause cancer or other adverse reactions. However, one study was located in the literature linking asthma and contact dermatitis to substances released from polyurethane chemicals. Another issue was the silicone used as the lubricant for the condom. Long-term exposure to silicone is still debated, but moderate amounts are harmless, according a Canadian official. The manufacturers are also considering providing Avanti with the nonoxynol-9 spermicide, which would need FDA approval. The safety of the Avanti's retention ring was also questioned. It is a rubber-based elastomer used for nonallergenic gloves, safe for people with allergies. In addition, polyurethane is not susceptible to ozone and oxidation, and its shelf life is three years, although it remains stable up to five years, according to durability tests. PMID:12290715

  18. FDA Recommends All Blood Donations Be Tested for Zika

    MedlinePlus

    ... FDA Recommends All Blood Donations Be Tested for Zika Updated guidance provides further protection for U.S. blood ... entire blood supply be routinely screened for the Zika virus. In February, the FDA recommended testing of ...

  19. Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

    PubMed

    Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

    2014-06-01

    This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed. PMID:24682644

  20. Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.

    PubMed

    Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

    2014-06-01

    This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.

  1. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  2. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  3. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  4. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102 Section 314.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications §...

  5. A novel glass slide filing system for pathology slides.

    PubMed

    Tsai, Steve; Kartono, Francisca; Shitabata, Paul K

    2007-07-01

    The availability of a collection of microscope glass slides for review is essential in the study and practice of pathology. A common problem facing many pathologists is the lack of a well-organized filing system. We present a novel system that would be easily accessible, informative, protective, and portable.

  6. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  7. FDA Approval Summary: Ramucirumab for Gastric Cancer.

    PubMed

    Casak, Sandra J; Fashoyin-Aje, Ibilola; Lemery, Steven J; Zhang, Lillian; Jin, Runyan; Li, Hongshan; Zhao, Liang; Zhao, Hong; Zhang, Hui; Chen, Huanyu; He, Kun; Dougherty, Michele; Novak, Rachel; Kennett, Sarah; Khasar, Sachia; Helms, Whitney; Keegan, Patricia; Pazdur, Richard

    2015-08-01

    The FDA approved ramucirumab (CYRAMZA; Eli Lilly and Company) for previously treated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma initially as monotherapy (April 21, 2014) and subsequently as combination therapy with paclitaxel (November 5, 2014). In the monotherapy trial, 355 patients in the indicated population were randomly allocated (2:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks. In the combination trial, 665 patients were randomly allocated (1:1) to receive ramucirumab or placebo, 8 mg/kg intravenously every 2 weeks, in combination with paclitaxel, 80 mg/m(2) on days 1, 8, and 15 of 28-day cycles. Overall survival (OS) was increased in patients who received ramucirumab in both the monotherapy [HR, 0.78; 95% confidence interval (CI), 0.60-0.998; log rank P = 0.047] and combination trials (HR, 0.81; 95% CI, 0.68-0.96; P = 0.017). The most common adverse reactions were hypertension and diarrhea in the monotherapy trial and fatigue, neutropenia, diarrhea, and epistaxis in the combination trial. Because of concerns about the robustness of the monotherapy trial results, FDA approved the original application after receiving the results of the combination trial confirming the OS effect. Based on exploratory exposure-response analyses, there is residual uncertainty regarding the optimal dose of ramucirumab.

  8. WTP Pretreatment Facility Potential Design Deficiencies--Sliding Bed and Sliding Bed Erosion Assessment

    SciTech Connect

    Hansen, E. K.

    2015-05-06

    This assessment is based on readily available literature and discusses both Newtonian and non-Newtonian slurries with respect to sliding beds and erosion due to sliding beds. This report does not quantify the size of the sliding beds or erosion rates due to sliding beds, but only assesses if they could be present. This assessment addresses process pipelines in the Pretreatment (PT) facility and the high level waste (HLW) transfer lines leaving the PT facility to the HLW vitrification facility concentrate receipt vessel.

  9. OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

    PubMed Central

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  10. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    PubMed

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  11. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    .... Conduct two food product tracing pilot projects--one in coordination with the processed food sector and... points of service; 6. Demonstrate the tracking and tracing of: (a) A selected processed food and its key... HUMAN SERVICES Food and Drug Administration Implementation of the FDA Food Safety Modernization...

  12. Mailing microscope slides

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Many insects feed agriculturally important crops, trees, and ornamental plants and cause millions of dollars of damage annually. Identification for some of these require the preparation of a microscope slide for examination. There are times when a microscope slide may need to be sent away to a speci...

  13. Dendritic spines and development: towards a unifying model of spinogenesis--a present day review of Cajal's histological slides and drawings.

    PubMed

    García-López, Pablo; García-Marín, Virginia; Freire, Miguel

    2010-01-01

    Dendritic spines receive the majority of excitatory connections in the central nervous system, and, thus, they are key structures in the regulation of neural activity. Hence, the cellular and molecular mechanisms underlying their generation and plasticity, both during development and in adulthood, are a matter of fundamental and practical interest. Indeed, a better understanding of these mechanisms should provide clues to the development of novel clinical therapies. Here, we present original results obtained from high-quality images of Cajal's histological preparations, stored at the Cajal Museum (Instituto Cajal, CSIC), obtained using extended focus imaging, three-dimensional reconstruction, and rendering. Based on the data available in the literature regarding the formation of dendritic spines during development and our results, we propose a unifying model for dendritic spine development.

  14. Dendritic Spines and Development: Towards a Unifying Model of Spinogenesis—A Present Day Review of Cajal's Histological Slides and Drawings

    PubMed Central

    García-López, Pablo; García-Marín, Virginia; Freire, Miguel

    2010-01-01

    Dendritic spines receive the majority of excitatory connections in the central nervous system, and, thus, they are key structures in the regulation of neural activity. Hence, the cellular and molecular mechanisms underlying their generation and plasticity, both during development and in adulthood, are a matter of fundamental and practical interest. Indeed, a better understanding of these mechanisms should provide clues to the development of novel clinical therapies. Here, we present original results obtained from high-quality images of Cajal's histological preparations, stored at the Cajal Museum (Instituto Cajal, CSIC), obtained using extended focus imaging, three-dimensional reconstruction, and rendering. Based on the data available in the literature regarding the formation of dendritic spines during development and our results, we propose a unifying model for dendritic spine development. PMID:21584262

  15. Sliding-Ring Catenanes.

    PubMed

    Fernando, Isurika R; Frasconi, Marco; Wu, Yilei; Liu, Wei-Guang; Wasielewski, Michael R; Goddard, William A; Stoddart, J Fraser

    2016-08-17

    Template-directed protocols provide a routine approach to the synthesis of mechanically interlocked molecules (MIMs), in which the mechanical bonds are stabilized by a wide variety of weak interactions. In this Article, we describe a strategy for the preparation of neutral [2]catenanes with sliding interlocked electron-rich rings, starting from two degenerate donor-acceptor [2]catenanes, consisting of a tetracationic cyclobis(paraquat-p-phenylene) cyclophane (CBPQT(4+)) and crown ethers containing either (i) hydroquinone (HQ) or (ii) 1,5-dioxynaphthalene (DNP) recognition units and carrying out four-electron reductions of the cyclophane components to their neutral forms. The donor-acceptor interactions between the CBPQT(4+) ring and both HQ and DNP units present in the crown ethers that stabilize the [2]catenanes are weakened upon reduction of the cyclophane components to their radical cationic states and are all but absent in their fully reduced states. Characterization in solution performed by UV-vis, EPR, and NMR spectroscopic probes reveals that changes in the redox properties of the [2]catenanes result in a substantial decrease of the energy barriers for the circumrotation and pirouetting motions of the interlocked rings, which glide freely through one another in the neutral states. The solid-state structures of the fully reduced catenanes reveal profound changes in the relative dispositions of the interlocked rings, with the glycol chains of the crown ethers residing in the cavities of the neutral CBPQT(0) rings. Quantum mechanical investigations of the energy levels associated with the four different oxidation states of the catenanes support this interpretation. Catenanes and rotaxanes with sliding rings are expected to display unique properties. PMID:27398609

  16. Biotechnology: the view from the FDA.

    PubMed

    Young, F E

    1986-01-01

    What is biotechnology? This is not a naive question. The Office of Technology Assessment has found differing definitions of biotechnology emanating from eight foreign countries and three international organizations. FDA's working definition of biotechnology is the application of biological systems and organisms to technical and industrial processes. This definition is necessarily broad. It takes in both the "old" and "new" science: the age-old techniques for making beer or yogurt as well as the most advanced uses of recombinant DNA technology. It takes in many applications, from production of enzymes for laundry detergents, to selective breeding of plants and animals, to genetic engineering of bacteria to clean up oil spills. As with any new technology, ethical issues are raised. But in the case of genetic engineering and cloning, many of the primordial fears of man concerning the power of science are awakened.

  17. US FDA oncology drug approvals in 2014.

    PubMed

    Wolford, Juliet E; Tewari, Krishnansu S

    2015-01-01

    Cancer is a close second to heart disease for cause of death in the USA, and could soon surpass heart disease as the population ages and the incidence of cancer continues to increase. While heart disease can be addressed through behavior modification and education (e.g., smoking cessation, dietary changes, exercises that promote cardiovascular fitness), pharmacology and improved surgical devices and methods, cancer ultimately requires improved and novel drug treatments to bring mortality rates down. In 2014, the US FDA approved 17 drugs and/or drug combinations in 12 disease sites for a total of 19 indications in melanoma, hematologic malignancies, gastrointestinal carcinoma, non-small-cell lung cancer, gynecologic malignancies and lymphoma/lymphoproliferative disorders. PMID:26039742

  18. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a petition filed under § 60.30(a),...

  19. Rheological behavior of Slide Ring Gels.

    NASA Astrophysics Data System (ADS)

    Sharma, Vivek; Park, Jong Seung; Park, Jung O.; Srinivasarao, Mohan

    2006-03-01

    Slide ring gels were synthesized by chemically crosslinking, sparsely populated α-cyclodextrin (α-CD) present on the polyrotaxanes consisting of α-CD and polyethylene glycol (PEG). [1] Unlike physically or chemically crosslinked gels, slide ring gels are topological gels where crosslinks can slide along the chain. [2] We investigate the rheological behavior of these gels swollen in water and compare their viscoelastic properties to those of physical and chemical gels. We also study the equilibrium swelling behavior of these gels. [1] Okumura and Ito, Adv. Mater. 2001, 13, 485 [2] C. Zhao et al, J. Phys. Cond. Mat. 2005, 17, S2841

  20. FDA-approved small-molecule kinase inhibitors.

    PubMed

    Wu, Peng; Nielsen, Thomas E; Clausen, Mads H

    2015-07-01

    Kinases have emerged as one of the most intensively pursued targets in current pharmacological research, especially for cancer, due to their critical roles in cellular signaling. To date, the US FDA has approved 28 small-molecule kinase inhibitors, half of which were approved in the past 3 years. While the clinical data of these approved molecules are widely presented and structure-activity relationship (SAR) has been reported for individual molecules, an updated review that analyzes all approved molecules and summarizes current achievements and trends in the field has yet to be found. Here we present all approved small-molecule kinase inhibitors with an emphasis on binding mechanism and structural features, summarize current challenges, and discuss future directions in this field.

  1. Ensuring the safe and effective FDA regulation of fecal microbiota transplantation

    PubMed Central

    Sachs, Rachel E.; Edelstein, Carolyn A.

    2015-01-01

    Scientists, policymakers, and medical professionals alike have become increasingly worried about the rise of antibiotic resistance, and the growing number of infections due to bacteria like Clostridium difficile, which cause a significant number of deaths and are imposing increasing costs on our health care system. However, in the last few years, fecal microbiota transplantation (FMT), the transplantation of stool from a healthy donor into the bowel of a patient, has emerged as a startlingly effective means to treat recurrent C. difficile infections. At present, the FDA is proposing to regulate FMT as a biologic drug. However, this proposed classification is both underregulatory and overregulatory. The FDA's primary goal is to ensure that patients have access to safe, effective treatments—and as such they should regulate some aspects of FMT more stringently than they propose to, and others less so. This essay will examine the nature of the regulatory challenges the FDA will face in deciding to regulate FMT as a biologic drug, and will then evaluate available policy alternatives for the FDA to pursue, ultimately concluding that the FDA ought to consider adopting a hybrid regulatory model as it has done in the case of cord blood. PMID:27774199

  2. Slides, Swings and Science.

    ERIC Educational Resources Information Center

    Dreyer, Kay Jardon; Bryte, Janelle

    1990-01-01

    Described are eight science activities that may take place on a school playground using a parachute, balls, swings, slides, and a balance beam. Procedures and questions for each activity are included. (CW)

  3. Prototype Slide Stainer

    NASA Technical Reports Server (NTRS)

    1971-01-01

    The prototype slide staining system capable of performing both one-component Wright's staining of blood smears and eight-step Gram staining of heat fixed slides of microorganisms is described. Attention was given to liquid containment, waste handling, absence of contamination from previous staining, and stability of the staining reagents. The unit is self-contained, capable of independent operation under one- or zero-g conditions, and compatible with Skylab A.

  4. Fundamentals of the Slide Library.

    ERIC Educational Resources Information Center

    Boerner, Susan Zee

    This paper is an introduction to the fundamentals of the art (including architecture) slide library, with some emphasis on basic procedures of the science slide library. Information in this paper is particularly relevant to the college, university, and museum slide library. Topics addressed include: (1) history of the slide library; (2) duties of…

  5. Selected Landscape Plants. Slide Script.

    ERIC Educational Resources Information Center

    McCann, Kevin

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with commercially important woody ornamental landscape plants. Included in the script are narrations for use with a total of 253 slides illustrating 92 different plants. Several slides are used to illustrate each plant: besides a view of…

  6. Ornamental Landscape Grasses. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven M.; Adams, Denise W.

    This slide script to accompany the slide series, Ornamental Landscape Grasses, contains photographs of the 167 slides and accompanying narrative text intended for use in the study and identification of commercially important ornamental grasses and grasslike plants. Narrative text is provided for slides of 62 different perennial and annual species…

  7. The Foley Acoustic Wave Front Slides

    NASA Astrophysics Data System (ADS)

    Greenslade, Thomas B.

    2004-04-01

    In 1912 Arthur L. Foley of Indiana University published an article in Physical Review about his technique for photographing acoustic wave fronts. Subsequently, the Central Scientific Company published a series of glass lantern slides of his illustrations. These have been unavailable for about 60 years. Here I discuss how Foley made his slides and give examples of use to the present-day physics teacher.

  8. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of...

  9. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5... ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management. The Division of Dockets Management public room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD...

  10. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives...

  11. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives...

  12. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives...

  13. FDA toxicity databases and real-time data entry

    SciTech Connect

    Arvidson, Kirk B.

    2008-11-15

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

  14. FDA toxicity databases and real-time data entry.

    PubMed

    Arvidson, Kirk B

    2008-11-15

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

  15. Sliding Motility in Mycobacteria

    PubMed Central

    Martínez, Asunción; Torello, Sandra; Kolter, Roberto

    1999-01-01

    Mycobacteria are nonflagellated gram-positive microorganisms. Previously thought to be nonmotile, we show here that Mycobacterium smegmatis can spread on the surface of growth medium by a sliding mechanism. M. smegmatis spreads as a monolayer of cells which are arranged in pseudofilaments by close cell-to-cell contacts, predominantly along their longitudinal axis. The monolayer moves away from the inoculation point as a unit with only minor rearrangements. No extracellular structures such as pili or fimbriae appear to be involved in this process. The ability to translocate over the surface correlates with the presence of glycopeptidolipids, a mycobacterium-specific class of amphiphilic molecules located in the outermost layer of the cell envelope. We present evidence that surface motility is not restricted to M. smegmatis but is also a property of the slow-growing opportunistic pathogen M. avium. This form of motility could play an important role in surface colonization by mycobacteria in the environment as well as in the host. PMID:10572138

  16. The Facts on the FDA's New Tobacco Rule

    MedlinePlus

    ... agency authority to regulate the manufacturing, distribution, and marketing of tobacco products. Today, the rule does several ... law. And those manufacturers will have to receive marketing authorization from the FDA. The new rule also ...

  17. FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance

    MedlinePlus

    ... FDA is using cutting-edge technology called whole genome sequencing (WGS). A genome is an organism’s complete set of genes. In the 20 years since the first bacterial genome was completely sequenced, the science has advanced dramatically. ...

  18. FDA Renews Call to Reduce Salt in Processed Foods

    MedlinePlus

    ... consume more salt than recommended, the FDA pointed out. The problem is widespread in children and teens, too. Foods that are often high in sodium include pizza, sandwiches, deli meats, pasta dishes, snacks, salad dressings, soups and cheese. The ...

  19. FDA Compliance Program Guidance Manual. Section VI. Radiological health

    SciTech Connect

    Not Available

    1981-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration field operations for project implementation.

  20. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

    ... Updates What FDA Learned About Dark Chocolate and Milk Allergies Share Tweet Linkedin Pin it More sharing ... to top No Message Doesn’t Mean No Milk You shouldn’t assume that dark chocolate contains ...

  1. FDA OKs 1st Drug to Treat Duchenne Muscular Dystrophy

    MedlinePlus

    ... html FDA OKs 1st Drug to Treat Duchenne Muscular Dystrophy Exondys 51 seems to fill unmet need for ... the first drug for a rare form of muscular dystrophy. Exondys 51 (eteplirsen) was granted accelerated approval to ...

  2. FDA Facilitates Research on Earlier Stages of Alzheimer's Disease

    MedlinePlus

    ... Updates FDA Facilitates Research on Earlier Stages of Alzheimer's Disease Share Tweet Linkedin Pin it More sharing ... disease.” back to top New Paths for New Alzheimer’s Drugs FDA’s draft guidance aims to encourage research ...

  3. Starting Monday, FDA Banning E-Cigarette Sales to Minors

    MedlinePlus

    ... news/fullstory_160310.html Starting Monday, FDA Banning E-Cigarette Sales to Minors Agency also details other ... Aug. 8, 2016 (HealthDay News) -- The sale of e-cigarettes to minors will be banned starting Monday, ...

  4. FDA OKs Non-Prescription Use of Acne Drug

    MedlinePlus

    ... 159779.html FDA OKs Non-Prescription Use of Acne Drug Differin Gel 0.1% is first retinoid ... July 8, 2016 (HealthDay News) -- Good news for acne sufferers: The U.S. Food and Drug Administration has ...

  5. Think Twice Before You Get That Tattoo: FDA

    MedlinePlus

    ... 159272.html Think Twice Before You Get That Tattoo: FDA Though popular, they carry infection risks and ... 8, 2016 WEDNESDAY, June 8, 2016 (HealthDay News) -- Tattoos are increasingly popular in the United States, but ...

  6. NCI Director Also to Be Interim FDA Commissioner

    Cancer.gov

    Andrew von Eschenbach, M.D., director of the NCI, was asked by President Bush on Friday, September 23, 2005, to assume the additional role of interim Commissioner of the U.S. Food and Drug Administration (FDA).

  7. Slowing the Summer Slide

    ERIC Educational Resources Information Center

    Smith, Lorna

    2012-01-01

    Research shows that summer slide--the loss of learning over the summer break--is a huge contributor to the achievement gap between low-income students and their higher-income peers. In fact, some researchers have concluded that two-thirds of the 9th-grade reading achievement gap can be explained by unequal access to summer learning opportunities…

  8. Reversing the Slide

    ERIC Educational Resources Information Center

    Gallagher, Michael

    2005-01-01

    The Government is embarking on a grand market-based vision for the sector just at the moment when university enrolments will begin a long and perhaps inexorable slide. And according to Michael Gallagher, higher education is becoming a less attractive investment for the private sector even as the Government is pushing the sector towards ever higher…

  9. Effect of the FDA on health care investments

    NASA Astrophysics Data System (ADS)

    Cleary, David J.

    1994-12-01

    The cost of securing FDA approval has long been an important consideration in funding projects involving new medical technologies, but the more stringent regulatory behavior of the FDA in the past few years has led to a discernable decrease in the funding of start-up medical device companies. An abundance of anecdotal evidence, supported with surveys of venture capital firms, investment groups and medical device corporations, indicates a serious shortage of funds available for the development of certain medical technologies.

  10. FDA regulation of adult stem cell therapies as used in sports medicine.

    PubMed

    Chirba, Mary Ann; Sweetapple, Berkley; Hannon, Charles P; Anderson, John A

    2015-02-01

    In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.

  11. Sliding wear and friction behaviour of zircaloy-4 in water

    NASA Astrophysics Data System (ADS)

    Sharma, Garima; Limaye, P. K.; Jadhav, D. T.

    2009-11-01

    In water cooled nuclear reactors, the sliding of fuel bundles in fuel channel handling system can lead to severe wear and it is an important topic to study. In the present study, sliding wear behaviour of zircaloy-4 was investigated in water (pH ˜ 10.5) using ball-on-plate sliding wear tester. Sliding wear resistance zircaloy-4 against SS 316 was examined at room temperature. Sliding wear tests were carried out at different load and sliding frequencies. The coefficient of friction of zircaloy-4 was also measured during each tests and it was found to decrease slightly with the increase in applied load. The micro-mechanisms responsible for wear in zircaloy-4 were identified to be microcutting, micropitting and microcracking of deformed subsurface zones in water.

  12. Application of partial sliding mode in guidance problem.

    PubMed

    Shafiei, M H; Binazadeh, T

    2013-03-01

    In this paper, the problem of 3-dimensional guidance law design is considered and a new guidance law based on partial sliding mode technique is presented. The approach is based on the classification of the state variables within the guidance system dynamics with respect to their required stabilization properties. In the proposed law by using a partial sliding mode technique, only trajectories of a part of states variables are forced to reach the partial sliding surfaces and slide on them. The resulting guidance law enables the missile to intercept highly maneuvering targets within a finite interception time. Effectiveness of the proposed guidance law is demonstrated through analysis and simulations.

  13. Theory of sliding-mode triboelectric nanogenerators.

    PubMed

    Niu, Simiao; Liu, Ying; Wang, Sihong; Lin, Long; Zhou, Yu Sheng; Hu, Youfan; Wang, Zhong Lin

    2013-11-20

    The triboelectric nanogenerator (TENG) is a powerful approach toward new energy technology, especially for portable electronics. A theoretical model for the sliding-mode TENG is presented in this work. The finite element method was utilized to characterize the distributions of electric potential, electric field, and charges on the metal electrodes of the TENG. Based on the FEM calculation, the semi-analytical results from the interpolation method and the analytical V-Q-x relationship are built to study the sliding-mode TENG. The analytical V-Q-x equation is validated through comparison with the semi-analytical results. Furthermore, based on the analytical V-Q-x equation, dynamic output performance of sliding-mode TENG is calculated with arbitrary load resistance, and good agreement with experimental data is achieved. The theory presented here is a milestone work for in-depth understanding of the working mechanism of the sliding-mode TENG, and provides a theoretical basis for further enhancement of the sliding-mode TENG for both energy scavenging and self-powered sensor applications.

  14. Railgun rail gouging by hypervelocity sliding contact

    SciTech Connect

    Barker, L.M.; Trucano, T.G. ); Susoeff, A.R. )

    1989-01-01

    A description is given of a recently resolved mechanisms of gouging which occurs during hypervelocity sliding contact between two materials. A parameter study based on computer modeling of the gouging mechanism is presented in which gouging velocity thresholds are determined for several combinations of sliding materials. Materials which can gouge each other are found to do so only within a certain range of velocities. Related calculations of gaseous material ahead of railgun projectiles are also presented. Gun bore gouging experience with the Lawrence Livermore National Laboratory railgun project is reviewed.

  15. Railgun rail gouging by hypervelocity sliding contact

    SciTech Connect

    Barker, L.M.; Trucano, T.G.; Susoeff, A.R.

    1988-01-01

    A description is given of a recently resolved mechanism of gouging which occurs during hypervelocity sliding contact between two materials. A parameter study based on computer modelling of the gouging mechanism is presented in which gouging velocity thresholds are determined for several combinations of sliding materials. Materials which can gouge each other are found to do so only within a certain range of velocities. Related calculations of gaseous material ahead of railgun projectiles are also presented. Gun bore gouging experience with the Lawrence Livermore National Laboratory railgun project is reviewed.

  16. Better slides needed at AGU Meetings

    NASA Astrophysics Data System (ADS)

    Jacobson, Randall S.

    Recent AGU meetings show a dangerous trend in the quality of presentations. A fair percentage of slides used during oral presentations consisted of a black background and colored lines and/or words for data. Such slides are illegible and serve to undercut the speaker's points by not demonstrating the data clearly.A typical example consisted of dark red, dark blue, and green data on a black background. Even the author had difficulty in pointing out the data using his light arrow. Line drawings, in particular, should not use colors, but instead use high-contrast white-on-black for the following reasons: dark colors on black backgrounds provide little contrast, making it difficult to discern patterns; people who are colorblind are at a disadvantage; and the same information can be obtained using a variety of line weights (dotdash, solid, dotted, etc.) with single color slides.

  17. Reconstitution of flagellar sliding.

    PubMed

    Alper, Joshua; Geyer, Veikko; Mukundan, Vikram; Howard, Jonathon

    2013-01-01

    The motile structure within eukaryotic cilia and flagella is the axoneme. This structure typically consists of nine doublet microtubules arranged around a pair of singlet microtubules. The axoneme contains more than 650 different proteins that have structural, force-generating, and regulatory functions. Early studies on sea urchin sperm identified the force-generating components, the dynein motors. It was shown that dynein can slide adjacent doublet microtubules in the presence of ATP. How this sliding gives rise to the beating of the axoneme is still unknown. Reconstitution assays provide a clean system, free from cellular effects, to elucidate the underlying beating mechanisms. These assays can be used to identify the components that are both necessary and sufficient for the generation of flagellar beating. PMID:23498749

  18. Reconstitution of flagellar sliding.

    PubMed

    Alper, Joshua; Geyer, Veikko; Mukundan, Vikram; Howard, Jonathon

    2013-01-01

    The motile structure within eukaryotic cilia and flagella is the axoneme. This structure typically consists of nine doublet microtubules arranged around a pair of singlet microtubules. The axoneme contains more than 650 different proteins that have structural, force-generating, and regulatory functions. Early studies on sea urchin sperm identified the force-generating components, the dynein motors. It was shown that dynein can slide adjacent doublet microtubules in the presence of ATP. How this sliding gives rise to the beating of the axoneme is still unknown. Reconstitution assays provide a clean system, free from cellular effects, to elucidate the underlying beating mechanisms. These assays can be used to identify the components that are both necessary and sufficient for the generation of flagellar beating.

  19. Imidization induced structural changes of 6FDA-ODA poly(amic acid) by two-dimensional (2D) infrared correlation spectroscopy

    NASA Astrophysics Data System (ADS)

    Seo, Hyemi; Chae, Boknam; Im, Ji Hyuk; Jung, Young Mee; Lee, Seung Woo

    2014-07-01

    Two-dimensional (2D) gradient mapping method and 2D correlation analysis of in situ FTIR spectra were used to probe the thermal imidization-induced spectral changes in 6FDA-ODA poly(amic acid) (PAA) films prepared by a reaction of 4,4‧-(hexafluoroisopropylidene)diphthalic anhydride (6FDA) and 4,4‧-oxydianiline (ODA) in N,N‧-dimethylacetamide. Large spectral changes in the in situ FTIR spectra of 6FDA-ODA PAA film were observed in the range, 130-230 °C. The thermal imidization of 6FDA-ODA PAA films strongly affects the spectral changes in amic acid groups in the PAA unit. The spectral change in the amic acid groups occurred before those of the imide ring. The cyclic anhydrides, isoimdes and intermolecular links are present together with the imide ring in the thermally-cured 6FDA-ODA PAA films.

  20. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

  1. Determining the Ecosystem Services Important for Urban Landscapes-Slides

    EPA Science Inventory

    This presentation consists of introductory slides on ecosystem services in urban landscapes and then a discussion of two case studies concerning the provision of water quality in urban landscapes. The introductory slides will explore the range of ecosystem services provided by u...

  2. The Easy Way to Create Computer Slide Shows.

    ERIC Educational Resources Information Center

    Anderson, Mary Alice

    1995-01-01

    Discusses techniques for creating computer slide shows. Topics include memory; format; color use; HyperCard and CD-ROM; font styles and sizes; graphs and graphics; the slide show option; special effects; and tips for effective presentation. (Author/AEF)

  3. A Simple Measurement of the Sliding Friction Coefficient

    ERIC Educational Resources Information Center

    Gratton, Luigi M.; Defrancesco, Silvia

    2006-01-01

    We present a simple computer-aided experiment for investigating Coulomb's law of sliding friction in a classroom. It provides a way of testing the possible dependence of the friction coefficient on various parameters, such as types of materials, normal force, apparent area of contact and sliding velocity.

  4. Qualification test unit slide stainer (Beckman P/N 673753)

    NASA Technical Reports Server (NTRS)

    Bernier, P. S.

    1972-01-01

    Specifications for a slide stainer unit for the Skylab program are presented. The qualification test slide stainer was designed to be a self-contained system capable of performing an eight-step Gram stain of microorganisms and a Wright's stain of blood smears.

  5. A Computer System for Making Quick and Economical Color Slides.

    ERIC Educational Resources Information Center

    Pryor, Harold George

    1986-01-01

    A computer-based method for producing 35mm color slides has been used in Ohio State University's College of Dentistry. The method can produce both text and slides in less than two hours, providing substantial flexibility in planning and revising visual presentations. (Author/MLW)

  6. FDA reform floated in DC. Food and Drug Administration.

    PubMed

    Hodel, D

    1995-06-01

    Legislative proposals to reform the mandate of the Food and Drug Administration (FDA) are underway in Washington. An ad hoc coalition has been formed by many leading AIDS groups to participate in the debate. The group is drafting principles for evaluating FDA reform proposals from the standpoint of people with life-threatening disease. Items under discussion for the reform include shifting more efficacy studies to a post-marketing setting. This would enable drugs to reach the market much faster; however, the risks are greater because more people will be taking the drugs with less data about hazards. Another measure would utilize local Institutional Review Boards (IRBs) to review proposals for the early human testing (phase I clinical trials) on drugs. In addition, a measure was proposed that would privatize certain drug safety reviews, by relegating them to independent testing or accrediting institutions. Another measure would permit the promotion of FDA-approved drugs for off-label uses. A measure to impose statutory time limits on FDA review is also under discussion. Finally, the possible removal of export barriers for non-FDA-approved drugs is under review.

  7. Healthy public relations: the FDA's 1930s legislative campaign.

    PubMed

    Kay, G

    2001-01-01

    In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more. PMID:11568487

  8. Influence of normal loads and sliding velocities on friction properties of engineering plastics sliding against rough counterfaces

    NASA Astrophysics Data System (ADS)

    Nuruzzaman, D. M.; Chowdhury, M. A.; Rahaman, M. L.; Oumer, A. N.

    2016-02-01

    Friction properties of plastic materials are very important under dry sliding contact conditions for bearing applications. In the present research, friction properties of engineering plastics such as polytetrafluoroethylene (PTFE) and nylon are investigated under dry sliding contact conditions. In the experiments, PTFE and nylon slide against different rough counterfaces such as mild steel and stainless steel 316 (SS 316). Frictional tests are carried out at low loads 5, 7.5 and 10 N, low sliding velocities 0.5, 0.75 and 1 m/s and relative humidity 70%. The obtained results reveal that friction coefficient of PTFE increases with the increase in normal loads and sliding velocities within the observed range. On the other hand, frictional values of nylon decrease with the increase in normal loads and sliding velocities. It is observed that in general, these polymers show higher frictional values when sliding against SS 316 rather than mild steel. During running-in process, friction coefficient of PTFE and nylon steadily increases with the increase in rubbing time and after certain duration of rubbing, it remains at steady level. At identical operating conditions, the frictional values are significantly different depending on normal load, sliding velocity and material pair. It is also observed that in general, the influence of normal load on the friction properties of PTFE and nylon is greater than that of sliding velocity.

  9. Microtubule sliding in reactivated flagella.

    PubMed

    Takahashi, K; Shingyoji, C; Kamimura, S

    1982-01-01

    Recent experimental studies of microtubule sliding in demembranated sea urchin sperm flagella are described. A local iontophoretic application of ATP to a Triton-extracted flagellum elicits a local bending response whose form is in exact conformity with the predictions of the sliding microtubule model. Cinematographic analysis of the microtubule sliding initiated by treating fragments of demembranated flagella with trypsin in the presence of ATP reveals that the speed of sliding is almost constant. This implies that the speed does not depend on the number of dynein arms participating in the generation of sliding force. The distribution of apparent sliding velocities indicates that there is no difference in sliding velocity among the doublets. The sliding velocity depends on MgATP concentration in a manner consistent with Michaelis-Menten kinetics. The sliding velocity of doublets in trypsin-treated axonemes is close to the maximum velocity of relative sliding taking place between adjacent doublets in beating flagella reactivated at the same MgATP concentration.

  10. America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

    PubMed

    Card, Melissa M

    2013-01-01

    R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products. PMID:24640612

  11. Metatarsal-slide lengthening without bone grafting.

    PubMed

    Tabak, B; Lefkowitz, H; Steiner, I

    1986-01-01

    Brachymetatarsia is a condition of premature closure of the epiphyseal plate of a metatarsal. The authors present a case of brachymetatarsia of the second metatarsal. Utilizing a review of the literature, various surgical procedures are discussed. Treatment in this case consisted of a metatarsal-slide lengthening osteotomy, a modification of the Giannestras step-down procedure. PMID:3950333

  12. Develop and Manufacture an airlock sliding tray

    SciTech Connect

    Lawton, Cindy M.

    2014-02-26

    Objective: The goal of this project is to continue to develop an airlock sliding tray and then partner with an industrial manufacturing company for production. The sliding tray will be easily installed into and removed from most glovebox airlocks in a few minutes. Technical Approach: A prototype of a sliding tray has been developed and tested in the LANL cold lab and 35 trays are presently being built for the plutonium facility (PF-4). The current, recently approved design works for a 14-inch diameter round airlock and has a tray length of approximately 20 inches. The grant will take the already tested and approved round technology and design for the square airlock. These two designs will be suitable for the majority of the existing airlocks in the multitude of DOE facilities. Partnering with an external manufacturer will allow for production of the airlock trays at a much lower cost and increase the availability of the product for all DOE sites. Project duration is estimated to be 12-13 months. Benefits: The purpose of the airlock sliding trays is fourfold: 1) Mitigate risk of rotator cuff injuries, 2) Improve ALARA, 3) Reduce risk of glovebox glove breaches and glove punctures, and 4) Improve worker comfort. I have had the opportunity to visit many other DOE facilities including Savannah, Y-12, ORNL, Sandia, and Livermore for assistance with ergonomic problems and/or injuries. All of these sites would benefit from the airlock sliding tray and I can assume all other DOE facilities with gloveboxes built prior to 1985 could also use the sliding trays.

  13. Sliding Fee Scales That Work: A Model for State Child Care Programs.

    ERIC Educational Resources Information Center

    Lookner, Sherrie

    Guiding principles for using sliding fee scales are presented in this paper in an effort to help states plan new child care initiatives, coordinate or strengthen existing programs, and improve sliding fee scales for current programs. Introductory comments urge states to adopt a single sliding fee scale for all their child care programs. The report…

  14. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products

  15. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  16. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  17. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  18. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM... not exercise due diligence such that, even if the petition were granted, the petition would not...

  19. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  20. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  1. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health...

  2. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  3. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  4. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  5. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  6. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Drugs Intended to Treat Life-threatening...

  7. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  8. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  9. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  10. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy.,...

  11. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy.,...

  12. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy.,...

  13. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  14. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer or importer required under this part to maintain records and...

  15. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  16. Network analysis of FDA approved drugs and their targets.

    PubMed

    Ma'ayan, Avi; Jenkins, Sherry L; Goldfarb, Joseph; Iyengar, Ravi

    2007-04-01

    The global relationship between drugs that are approved for therapeutic use and the human genome is not known. We employed graph-theory methods to analyze the Federal Food and Drug Administration (FDA) approved drugs and their known molecular targets. We used the FDA Approved Drug Products with Therapeutic Equivalence Evaluations 26(th) Edition Electronic Orange Book (EOB) to identify all FDA approved drugs and their active ingredients. We then connected the list of active ingredients extracted from the EOB to those known human protein targets included in the DrugBank database and constructed a bipartite network. We computed network statistics and conducted Gene Ontology analysis on the drug targets and drug categories. We find that drug to drug-target relationship in the bipartite network is scale-free. Several classes of proteins in the human genome appear to be better targets for drugs since they appear to be selectively enriched as drug targets for the currently FDA approved drugs. These initial observations allow for development of an integrated research methodology to identify general principles of the drug discovery process. PMID:17516560

  17. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  18. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of... written notice recognizing exclusive approval once the marketing application for a designated orphan-drug... orphan-drug exclusive approval for the full 7-year term of exclusive approval. (b) When a...

  19. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products. PMID:27668042

  20. Teaching Veterinary Histopathology: A Comparison of Microscopy and Digital Slides.

    PubMed

    Brown, Peter J; Fews, Debra; Bell, Nick J

    2016-01-01

    Virtual microscopy using digitized slides has become more widespread in teaching in recent years. There have been no direct comparisons of the use of virtual microscopy and the use of microscopes and glass slides. Third-year veterinary students from two different schools completed a simple objective test, covering aspects of histology and histopathology, before and after a practical class covering relevant material presented as either glass slides viewed with a microscope or as digital slides. There was an overall improvement in performance by students at both veterinary schools using both practical formats. Neither format was consistently better than the other, and neither school consistently outperformed the other. In a comparison of student appraisal of use of digital slides and microscopes, the digital technology was identified as having many advantages.

  1. Detection of felt tip markers on microscope slides

    NASA Astrophysics Data System (ADS)

    Friedrich, David; Meyer-Ebrecht, Dietrich; Böcking, Alfred; Merhof, Dorit

    2014-03-01

    Sensitivity and specificity of conventional cytological methods for cancer diagnosis can be raised significantly by applying further adjuvant cytological methods. To this end, the pathologist marks regions of interest (ROI) with a felt tip pen on the microscope slide for further analysis. This paper presents algorithms for the automated detection of these ROIs, which enables further automated processing of these regions by digital pathology solutions and image analysis. For this purpose, an overview scan is obtained at low magnification. Slides from different manufacturers need to be treated, as they might contain certain regions which need to be excluded from the analysis. Therefore the slide type is identified first. Subsequently, the felt tip marks are detected automatically, and gaps appearing in the case of ROIs which have been drawn incompletely are closed. Based on the marker detection, the ROIs are obtained. The algorithms have been optimized on a training set of 82 manually annotated images. On the test set, the slide types of all but one out of 81 slides were identified correctly. A sensitivity of 98.31% and a positive predictive value of 97.48% were reached for the detection of ROIs. In combination with a slide loader or a whole slide imaging scanner as well as automated image analysis, this enables fully automated batch processing of slides.

  2. DPS Discovery Slide Sets for the Introductory Astronomy Instructor

    NASA Astrophysics Data System (ADS)

    Meinke, Bonnie K.; Jackson, Brian; Buxner, Sanlyn; Horst, Sarah; Brain, David; Schneider, Nicholas M.

    2016-10-01

    The DPS actively supports the E/PO needs of the society's membership, including those at the front of the college classroom. The DPS Discovery Slide Sets are an opportunity for instructors to put the latest planetary science into their lectures and for scientists to get their exciting results to college students.In an effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division for Planetary Sciences (DPS) has developed "DPS Discoveries", which are 3-slide presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides which cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide that includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and 26 sets are available in Farsi and Spanish. We intend for these slide sets to help Astronomy 101 instructors include new developments (not yet in their textbooks) into the broader context of the course. If you need supplemental material for your classroom, please checkout the archived collection: http://dps.aas.org/education/dpsdiscMore slide sets are now in development and will be available soon! In the meantime, we seek input, feedback, and help from the DPS membership to add fresh slide sets to the series and to connect the college classroom to YOUR science. It's easy to get involved – we'll provide a content template, tips and tricks for a great slide set, and pedagogy reviews. Talk to a coauthor to find out how you can disseminate your science or get involved in E/PO with your contributions.

  3. Using Scrap Slides for Art.

    ERIC Educational Resources Information Center

    Hanlon, Heather

    1979-01-01

    Using scrap slides for an art lesson can be an exciting, creative experience for people of all ages, and many techniques are applicable in both primary and secondary grades. Scrap slides are an inexpensive means to unique, original, and stimulating discoveries about film as an art form. (Author)

  4. Introducing Slide Sets for the Introductory Astronomy Instructor

    NASA Astrophysics Data System (ADS)

    Meinke, Bonnie K.; Schneider, Nicholas; Brain, David; Schultz, Gregory; Buxner, Sanlyn; Smith, Denise

    2014-11-01

    The NASA Science Mission Directorate (SMD) Science Education and Public Outreach (E/PO) community and Forums work together to bring the cutting-edge discoveries of NASA Astrophysics and Planetary Science missions to the introductory astronomy college classroom. These mission- and grant-based E/PO programs are uniquely poised to foster collaboration between scientists with content expertise and educators with pedagogy expertise. We present two new opportunities for college instructors to bring the latest NASA discoveries in Space Science into their classrooms.In an effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division of Planetary Sciences (DPS) has developed “DPS Discoveries”, which are short, topical presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides that cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide that includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and sets are available in Farsi and Spanish. The NASA SMD Planetary Science Forum has recently partnered with the DPS to continue producing the Discovery slides and connect them to NASA mission science. http://dps.aas.org/education/dpsdisc Similarly, the NASA SMD Astrophysics Forum is coordinating the development of a series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The “Astro 101 slide sets” are presentations 5-7 slides in length on a new development or discovery from a NASA Astrophysics mission relevant to topics in introductory astronomy courses. We intend for these slide sets to help Astronomy 101 instructors include new developments (not yet in their textbooks) into the

  5. FDA use of international standards in the premarket review process.

    PubMed

    Rechen, E; Barth, D J; Marlowe, D; Kroger, L

    1998-01-01

    "This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European

  6. Revisiting Financial Conflicts of Interest in FDA Advisory Committees

    PubMed Central

    Pham-Kanter, Genevieve

    2014-01-01

    Context The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members’ financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. Methods The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997–2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members’ financial interests and their voting behavior. Findings Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). Conclusions There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial

  7. T-Slide Linear Actuators

    NASA Technical Reports Server (NTRS)

    Vranish, John

    2009-01-01

    T-slide linear actuators use gear bearing differential epicyclical transmissions (GBDETs) to directly drive a linear rack, which, in turn, performs the actuation. Conventional systems use a rotary power source in conjunction with a nut and screw to provide linear motion. Non-back-drive properties of GBDETs make the new actuator more direct and simpler. Versions of this approach will serve as a long-stroke, ultra-precision, position actuator for NASA science instruments, and as a rugged, linear actuator for NASA deployment duties. The T slide can operate effectively in the presence of side forces and torques. Versions of the actuator can perform ultra-precision positioning. A basic T-slide actuator is a long-stroke, rack-and-pinion linear actuator that, typically, consists of a T-slide, several idlers, a transmission to drive the slide (powered by an electric motor) and a housing that holds the entire assembly. The actuator is driven by gear action on its top surface, and is guided and constrained by gear-bearing idlers on its other two parallel surfaces. The geometry, implemented with gear-bearing technology, is particularly effective. An electronic motor operating through a GBDET can directly drive the T slide against large loads, as a rack and pinion linear actuator, with no break and no danger of back driving. The actuator drives the slide into position and stops. The slide holes position with power off and no brake, regardless of load. With the T slide configuration, this GBDET has an entire T-gear surface on which to operate. The GB idlers coupling the other two T slide parallel surfaces to their housing counterpart surfaces provide constraints in five degrees-of-freedom and rolling friction in the direction of actuation. Multiple GB idlers provide roller bearing strength sufficient to support efficient, rolling friction movement, even in the presence of large, resisting forces. T-slide actuators can be controlled using the combination of an off

  8. An analysis of FDA-approved drugs for neurological disorders.

    PubMed

    Kinch, Michael S

    2015-09-01

    Neuroscience remains a great challenge and opportunity in terms of new drug discovery and development. An assessment of FDA-approved new molecular entities (NMEs) reveals a low steady rate of new FDA approvals, which is interrupted by two bursts in activity, first in the 1950s and then in the 1990s. These trends are reflected in the approvals for NMEs targeting multiple indications in this field, including seizure, Parkinson's disease and neuromuscular disorders. The majority of drugs target ion channels or G-protein-coupled receptors (GPCRs) but the mechanistic basis for many NMEs remains unclear or controversial. These trends could suggest future opportunities for success in a crucial field with considerable unmet needs.

  9. FDA seeks temporary blood donor changes. Food and Drug Administration.

    PubMed

    1997-02-01

    The Food and Drug Administration (FDA) has requested that blood collection agencies exclude donors at risk of Group O HIV, following two cases identified in 1996. Group O is very rare in the United States. Blood donors would be excluded if they were born or lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger or Nigeria since 1977, or had sexual conduct with anyone traveling to those areas. The number of excluded donors would be minute.

  10. Robust sliding mode control applied to double Inverted pendulum system

    SciTech Connect

    Mahjoub, Sonia; Derbel, Nabil; Mnif, Faical

    2009-03-05

    A three hierarchical sliding mode control is presented for a class of an underactuated system which can overcome the mismatched perturbations. The considered underactuated system is a double inverted pendulum (DIP), can be modeled by three subsystems. Such structure allows the construction of several designs of hierarchies for the controller. For all hierarchical designs, the asymptotic stability of every layer sliding mode surface and the sliding mode surface of subsystems are proved theoretically by Barbalat's lemma. Simulation results show the validity of these methods.

  11. Robust sliding mode control applied to double Inverted pendulum system

    NASA Astrophysics Data System (ADS)

    Mahjoub, Sonia; Mnif, Faiçal; Derbel, Nabil

    2009-03-01

    A three hierarchical sliding mode control is presented for a class of an underactuated system which can overcome the mismatched perturbations. The considered underactuated system is a double inverted pendulum (DIP), can be modeled by three subsystems. Such structure allows the construction of several designs of hierarchies for the controller. For all hierarchical designs, the asymptotic stability of every layer sliding mode surface and the sliding mode surface of subsystems are proved theoretically by Barbalat's lemma. Simulation results show the validity of these methods.

  12. The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

    PubMed Central

    Wittes, Janet; Crowe, Brenda; Chuang-Stein, Christy; Guettner, Achim; Hall, David; Jiang, Qi; Odenheimer, Daniel; Xia, H. Amy; Kramer, Judith

    2015-01-01

    In March 2011, a Final Rule for expedited reporting of serious adverse events took effect in the United States for studies conducted under an Investigational New Drug (IND) application. In December 2012, the U.S. Food and Drug Administration (FDA) promulgated a final Guidance describing the operationalization of this Final Rule. The Rule and Guidance clarified that a clinical trial sponsor should have evidence suggesting causality before defining an unexpected serious adverse event as a suspected adverse reaction that would require expedited reporting to the FDA. The Rule's emphasis on the need for evidence suggestive of a causal relation should lead to fewer events being reported but, among those reported, a higher percentage actually being caused by the product being tested. This article reviews the practices that were common before the Final Rule was issued and the approach the New Rule specifies. It then discusses methods for operationalizing the Final Rule with particular focus on relevant statistical considerations. It concludes with a set of recommendations addressed to Sponsors and to the FDA in implementing the Final Rule. PMID:26550466

  13. FDA review panel gives thumbs up to Norplant.

    PubMed

    1989-05-01

    On April 27, the Fertility and Maternal Health Drugs Advisory Committee of the US Food and Drug Administration (FDA) unanimously recommended that Norplant, a long-acting contraceptive implant, be given final FDA approval for marketing in the US. This comes after almost 20 years of research conducted around the world. It was also announced that Wyeth-Ayerst would be manufacturing Norplant for distribution in the US as well as marketing it in countries overseas. FDA officials expect final approval of Norplant, along with its labeling, to be completed within the next several weeks. Norplant will be introduced to the US market, however, only after a full-scale training program has been instituted to ensure enough well-trained providers for both insertion and removal. Wyeth company representatives plan to immediately begin working with experts at the Population Council, and they expect Norplant to be ready for marketing within a year. The final cost of the new method remains in question and detailed post-marketing surveillance studies need to be ready for implementation.

  14. QSAR Models at the US FDA/NCTR.

    PubMed

    Hong, Huixiao; Chen, Minjun; Ng, Hui Wen; Tong, Weida

    2016-01-01

    Quantitative structure-activity relationship (QSAR) has been used in the scientific research community for many decades and applied to drug discovery and development in the industry. QSAR technologies are advancing fast and attracting possible applications in regulatory science. To facilitate the development of reliable QSAR models, the FDA had invested a lot of efforts in constructing chemical databases with a variety of efficacy and safety endpoint data, as well as in the development of computational algorithms. In this chapter, we briefly describe some of the often used databases developed at the FDA such as EDKB (Endocrine Disruptor Knowledge Base), EADB (Estrogenic Activity Database), LTKB (Liver Toxicity Knowledge Base), and CERES (Chemical Evaluation and Risk Estimation System) and the technologies adopted by the agency such as Mold(2) program for calculation of a large and diverse set of molecular descriptors and decision forest algorithm for QSAR model development. We also summarize some QSAR models that have been developed for safety evaluation of the FDA-regulated products. PMID:27311476

  15. FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident

    MedlinePlus

    ... ia/importalert_621.html FDA may adjust this strategy based on additional information received from monitoring results in Japan. FDA may also further evaluate this strategy if the Government of Japan makes changes to ...

  16. FDA Regulates Tobacco Maps and Data of Model-Based Small Area Estimates - Small Area Estimates

    Cancer.gov

    FDA Regulates Tobacco is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

  17. A novel adaptive sliding mode control with application to MEMS gyroscope.

    PubMed

    Fei, Juntao; Batur, Celal

    2009-01-01

    This paper presents a new adaptive sliding mode controller for MEMS gyroscope; an adaptive tracking controller with a proportional and integral sliding surface is proposed. The adaptive sliding mode control algorithm can estimate the angular velocity and the damping and stiffness coefficients in real time. A proportional and integral sliding surface, instead of a conventional sliding surface is adopted. An adaptive sliding mode controller that incorporates both matched and unmatched uncertainties and disturbances is derived and the stability of the closed-loop system is established. The numerical simulation is presented to verify the effectiveness of the proposed control scheme. It is shown that the proposed adaptive sliding mode control scheme offers several advantages such as the consistent estimation of gyroscope parameters including angular velocity and large robustness to parameter variations and external disturbances.

  18. Single molecule study of a processivity clamp sliding on DNA

    SciTech Connect

    Laurence, T A; Kwon, Y; Johnson, A; Hollars, C; O?Donnell, M; Camarero, J A; Barsky, D

    2007-07-05

    Using solution based single molecule spectroscopy, we study the motion of the polIII {beta}-subunit DNA sliding clamp ('{beta}-clamp') on DNA. Present in all cellular (and some viral) forms of life, DNA sliding clamps attach to polymerases and allow rapid, processive replication of DNA. In the absence of other proteins, the DNA sliding clamps are thought to 'freely slide' along the DNA; however, the abundance of positively charged residues along the inner surface may create favorable electrostatic contact with the highly negatively charged DNA. We have performed single-molecule measurements on a fluorescently labeled {beta}-clamp loaded onto freely diffusing plasmids annealed with fluorescently labeled primers of up to 90 bases. We find that the diffusion constant for 1D diffusion of the {beta}-clamp on DNA satisfies D {le} 10{sup -14} cm{sup 2}/s, much slower than the frictionless limit of D = 10{sup -10} cm{sup 2}/s. We find that the {beta} clamp remains at the 3-foot end in the presence of E. coli single-stranded binding protein (SSB), which would allow for a sliding clamp to wait for binding of the DNA polymerase. Replacement of SSB with Human RP-A eliminates this interaction; free movement of sliding clamp and poor binding of clamp loader to the junction allows sliding clamp to accumulate on DNA. This result implies that the clamp not only acts as a tether, but also a placeholder.

  19. Humboldt slide - A large shear-dominated retrogressive slope failure

    USGS Publications Warehouse

    Gardner, J.V.; Prior, D.B.; Field, M.E.

    1999-01-01

    Humboldt Slide is a large, complex slide zone located on the northern California continental margin. Its three-dimensional architecture has been imaged by a combination of multibeam bathymetry, Huntec Deep-Tow seismic profiling, and sidescan sonar. The slide is interpreted to be Late Pleistocene to early Holocene in age and was caused by a combination of factors. The area of the slide is a local depocenter with high accumulation rates of organic-rich sediment; there has been local steepening of slopes by tectonic uplifts; and the entire area is one of high seismicity. Overall, the failure occurred by retrogressive, shear-dominated, minimum movement apparently as a sequence of events. Failure initially occurred by subsidence extension at the middle of the feature, followed by upslope retrogressive failure and downslope compression, and finally by translational sliding at the top of the slide. Degassing, as evidenced by abundant pockmarks, may have inhibited downslope translation. The slide may still be active, as suggested by offsets in Holocene hemipelagic sediment draped over some of the shear surfaces. Crown cracks occur above the present head of the failure and may represent the next generation of failure.

  20. Second-order sliding mode control with experimental application.

    PubMed

    Eker, Ilyas

    2010-07-01

    In this article, a second-order sliding mode control (2-SMC) is proposed for second-order uncertain plants using equivalent control approach to improve the performance of control systems. A Proportional + Integral + Derivative (PID) sliding surface is used for the sliding mode. The sliding mode control law is derived using direct Lyapunov stability approach and asymptotic stability is proved theoretically. The performance of the closed-loop system is analysed through an experimental application to an electromechanical plant to show the feasibility and effectiveness of the proposed second-order sliding mode control and factors involved in the design. The second-order plant parameters are experimentally determined using input-output measured data. The results of the experimental application are presented to make a quantitative comparison with the traditional (first-order) sliding mode control (SMC) and PID control. It is demonstrated that the proposed 2-SMC system improves the performance of the closed-loop system with better tracking specifications in the case of external disturbances, better behavior of the output and faster convergence of the sliding surface while maintaining the stability.

  1. An Airship Slide Rule

    NASA Technical Reports Server (NTRS)

    Weaver, E R; Pickering, S F

    1924-01-01

    This report prepared for the National Advisory Committee for Aeronautics, describes an airship slide rule developed by the Gas-Chemistry Section of the Bureau of Standards, at the request of the Bureau of Engineering of the Navy Department. It is intended primarily to give rapid solutions of a few problems of frequent occurrence in airship navigation, but it can be used to advantage in solving a great variety of problems, involving volumes, lifting powers, temperatures, pressures, altitudes and the purity of the balloon gas. The rule is graduated to read directly in the units actually used in making observations, constants and conversion factors being taken care of by the length and location of the scales. It is thought that with this rule practically any problem likely to arise in this class of work can be readily solved after the user has become familiar with the operation of the rule; and that the solution will, in most cases, be as accurate as the data warrant.

  2. No sisyphean task: how the FDA can regulate electronic cigarettes.

    PubMed

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  3. No sisyphean task: how the FDA can regulate electronic cigarettes.

    PubMed

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  4. Vesicocutaneous fistula after sliding hernia repair

    PubMed Central

    Mittal, Varun; Kapoor, Rakesh; Sureka, Sanjoy

    2016-01-01

    Sliding inguinal hernias are usually direct inguinal hernias containing various abdominal viscera. The incidence of bladder forming a part of an inguinal hernia, called as “scrotal cystocele,” is 1–4%. The risk of bladder injury is as high as 12% when repairing this type of hernia. This case report emphasizes this aspect in a 65-year-old man who presented with urinary leak through the scrotal wound following right inguinal hernia repair. PMID:26941501

  5. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379... GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  6. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

  7. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How long may FDA detain an article of food? 1.379... GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  8. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379... GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  9. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

  10. Sliding Mode Thermal Control System for Space Station Furnace Facility

    NASA Technical Reports Server (NTRS)

    Jackson Mark E.; Shtessel, Yuri B.

    1998-01-01

    The decoupled control of the nonlinear, multiinput-multioutput, and highly coupled space station furnace facility (SSFF) thermal control system is addressed. Sliding mode control theory, a subset of variable-structure control theory, is employed to increase the performance, robustness, and reliability of the SSFF's currently designed control system. This paper presents the nonlinear thermal control system description and develops the sliding mode controllers that cause the interconnected subsystems to operate in their local sliding modes, resulting in control system invariance to plant uncertainties and external and interaction disturbances. The desired decoupled flow-rate tracking is achieved by optimization of the local linear sliding mode equations. The controllers are implemented digitally and extensive simulation results are presented to show the flow-rate tracking robustness and invariance to plant uncertainties, nonlinearities, external disturbances, and variations of the system pressure supplied to the controlled subsystems.

  11. Adaptive sliding mode control for a class of chaotic systems

    SciTech Connect

    Farid, R.; Ibrahim, A.; Zalam, B.

    2015-03-30

    Chaos control here means to design a controller that is able to mitigating or eliminating the chaos behavior of nonlinear systems that experiencing such phenomenon. In this paper, an Adaptive Sliding Mode Controller (ASMC) is presented based on Lyapunov stability theory. The well known Chua's circuit is chosen to be our case study in this paper. The study shows the effectiveness of the proposed adaptive sliding mode controller.

  12. Analysis and Synthesis of Memory-Based Fuzzy Sliding Mode Controllers.

    PubMed

    Zhang, Jinhui; Lin, Yujuan; Feng, Gang

    2015-12-01

    This paper addresses the sliding mode control problem for a class of Takagi-Sugeno fuzzy systems with matched uncertainties. Different from the conventional memoryless sliding surface, a memory-based sliding surface is proposed which consists of not only the current state but also the delayed state. Both robust and adaptive fuzzy sliding mode controllers are designed based on the proposed memory-based sliding surface. It is shown that the sliding surface can be reached and the closed-loop control system is asymptotically stable. Furthermore, to reduce the chattering, some continuous sliding mode controllers are also presented. Finally, the ball and beam system is used to illustrate the advantages and effectiveness of the proposed approaches. It can be seen that, with the proposed control approaches, not only can the stability be guaranteed, but also its transient performance can be improved significantly.

  13. Temperature rise and wear of sliding contact of alloy steels

    NASA Astrophysics Data System (ADS)

    Goswami, Arindam Roy; Sardar, Santanu; Karmakar, Santanu Kumar

    2016-07-01

    The tribo-failure of machine elements under relative sliding velocities is greatly affected by frictional heating and resultant contact temperature rise. Nevertheless, the tribo-failure of automotive components is a combined effect of mechanical, thermal and chemical phenomena. Over the decades, there have been developed a number of different mathematical models for predicting surface temperature rise at sliding contact under different geometries of asperity contacts and operating conditions. The experimental investigation is still relevant today to find out the surface temperature rise at sliding contact along with the outcomes of friction and wear under various operating conditions for real time applications. The present work aims at finding average surface temperature rise at different sliding velocities, normal loads with different surface roughness experimentally. It also involves to prepare two different rough surfaces of alloy steels and to study their influences in the process of generating contact temperature rise under a given operating conditions.

  14. 2015 in review: FDA approval of new drugs.

    PubMed

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise. PMID:27109618

  15. The new label for erythropoiesis stimulating agents: the FDA'S sentence.

    PubMed

    Fishbane, Steven; Jhaveri, Kenar D

    2012-05-01

    On June 24, 2011, the U.S. Food and Drug Administration (FDA) revised the prescribing instructions (the label) for erythropoiesis-stimulating agents. The new label, the second revision since publication of the TREAT Study, placed new restrictions on the use of these agents, and increased the strength of warnings. We believe that the new label language may deprive patients of the full benefits of erythropoiesis-stimulating agent treatment and impair the opportunity to individualize treatment through shared decision making. Diminished discovery and innovation in the treatment of one of the most common and important complications of kidney disease may also be an unintended consequence of the label change. PMID:22515844

  16. FDA's Laser Notice 50: a step toward global harmonization

    NASA Astrophysics Data System (ADS)

    Kent, Suzie L. B.; Dennis, Jerome E.; Zaharek, Gary L.; Eng, Francis J.

    2003-06-01

    The US Food and Drug Administration, Center of Devices and Radiological Health issued Laser Notice 50 in July 2001. This Notice is a preliminary step that FDA has taken to harmonize US regulations for laser products (21 Code of Federal Regulations) with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products. The paper discusses rationale for the changes and describes some of the implementation issues, including comparisons between the current standards. The impact on the regulated industry and the user community is that the same laser hazard classification scheme is used and that engineered safety features are consistentin the world markets.

  17. An analysis of FDA-approved drugs for oncology.

    PubMed

    Kinch, Michael S

    2014-12-01

    Cancer remains the second leading cause of death globally. The number of new medicines targeting cancer has grown impressively since the 1990s. On average, ten new drugs are introduced each year. Such growth has partly been achieved by emphasizing biologics and orphan indications, which account for one-quarter and one-half of new oncology drugs, respectively. The biotechnology industry likewise has become the primary driver of cancer drug development in terms of patents, preclinical and clinical research, although pharmaceutical companies are granted more FDA approvals. Many targeting strategies have been successful but recent trends suggest that kinase targets, although tractable, might be overemphasized.

  18. Analysis of Transitional and Turbulent Flow Through the FDA Benchmark Nozzle Model Using Laser Doppler Velocimetry.

    PubMed

    Taylor, Joshua O; Good, Bryan C; Paterno, Anthony V; Hariharan, Prasanna; Deutsch, Steven; Malinauskas, Richard A; Manning, Keefe B

    2016-09-01

    Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA's Critical Path Initiative, designed to improve the process of bringing medical products to market. Computational predictions are often used in the development of devices and reliable in vitro data is needed to validate computational results, particularly estimations of the Reynolds stresses that could play a role in damaging blood elements. The high spatial resolution of laser Doppler velocimetry (LDV) is used to collect two component velocity data within the FDA benchmark nozzle model. Two flow conditions are used to produce flow encompassing laminar, transitional, and turbulent regimes, and viscous stresses, principal Reynolds stresses, and turbulence intensities are calculated from the measured LDV velocities. Axial velocities and viscous stresses are compared to data from a prior inter-laboratory study conducted with particle image velocimetry. Large velocity gradients are observed near the wall in the nozzle throat and in the jet shear layer located in the expansion downstream of the throat, with axial velocity changing as much as 4.5 m/s over 200 μm. Additionally, maximum Reynolds shear stresses of 1000-2000 Pa are calculated in the high shear regions, which are an order of magnitude higher than the peak viscous shear stresses (<100 Pa). It is important to consider the effects of both viscous and turbulent stresses when simulating flow through medical devices. Reynolds stresses above commonly accepted hemolysis thresholds are measured in the nozzle model, indicating that hemolysis may occur under certain flow conditions. As such, the presented turbulence quantities from LDV, which are also available for download at https://fdacfd.nci.nih.gov/ , provide an ideal validation test for computational simulations that seek to characterize the flow field and to predict hemolysis within the FDA nozzle geometry. PMID:27350137

  19. Analysis of Transitional and Turbulent Flow Through the FDA Benchmark Nozzle Model Using Laser Doppler Velocimetry.

    PubMed

    Taylor, Joshua O; Good, Bryan C; Paterno, Anthony V; Hariharan, Prasanna; Deutsch, Steven; Malinauskas, Richard A; Manning, Keefe B

    2016-09-01

    Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA's Critical Path Initiative, designed to improve the process of bringing medical products to market. Computational predictions are often used in the development of devices and reliable in vitro data is needed to validate computational results, particularly estimations of the Reynolds stresses that could play a role in damaging blood elements. The high spatial resolution of laser Doppler velocimetry (LDV) is used to collect two component velocity data within the FDA benchmark nozzle model. Two flow conditions are used to produce flow encompassing laminar, transitional, and turbulent regimes, and viscous stresses, principal Reynolds stresses, and turbulence intensities are calculated from the measured LDV velocities. Axial velocities and viscous stresses are compared to data from a prior inter-laboratory study conducted with particle image velocimetry. Large velocity gradients are observed near the wall in the nozzle throat and in the jet shear layer located in the expansion downstream of the throat, with axial velocity changing as much as 4.5 m/s over 200 μm. Additionally, maximum Reynolds shear stresses of 1000-2000 Pa are calculated in the high shear regions, which are an order of magnitude higher than the peak viscous shear stresses (<100 Pa). It is important to consider the effects of both viscous and turbulent stresses when simulating flow through medical devices. Reynolds stresses above commonly accepted hemolysis thresholds are measured in the nozzle model, indicating that hemolysis may occur under certain flow conditions. As such, the presented turbulence quantities from LDV, which are also available for download at https://fdacfd.nci.nih.gov/ , provide an ideal validation test for computational simulations that seek to characterize the flow field and to predict hemolysis within the FDA nozzle geometry.

  20. NIEHS/FDA CLARITY-BPA research program update.

    PubMed

    Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

    2015-12-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program.

  1. Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.

    PubMed

    Sawant, Satin G; Fielden, Mark R; Black, Kurt A

    2014-10-01

    Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.

  2. NIEHS/FDA CLARITY-BPA research program update.

    PubMed

    Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

    2015-12-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

  3. FDA Escherichia coli Identification (FDA-ECID) Microarray: a Pangenome Molecular Toolbox for Serotyping, Virulence Profiling, Molecular Epidemiology, and Phylogeny

    PubMed Central

    Patel, Isha R.; Gangiredla, Jayanthi; Lacher, David W.; Mammel, Mark K.; Jackson, Scott A.; Lampel, Keith A.

    2016-01-01

    ABSTRACT Most Escherichia coli strains are nonpathogenic. However, for clinical diagnosis and food safety analysis, current identification methods for pathogenic E. coli either are time-consuming and/or provide limited information. Here, we utilized a custom DNA microarray with informative genetic features extracted from 368 sequence sets for rapid and high-throughput pathogen identification. The FDA Escherichia coli Identification (FDA-ECID) platform contains three sets of molecularly informative features that together stratify strain identification and relatedness. First, 53 known flagellin alleles, 103 alleles of wzx and wzy, and 5 alleles of wzm provide molecular serotyping utility. Second, 41,932 probe sets representing the pan-genome of E. coli provide strain-level gene content information. Third, approximately 125,000 single nucleotide polymorphisms (SNPs) of available whole-genome sequences (WGS) were distilled to 9,984 SNPs capable of recapitulating the E. coli phylogeny. We analyzed 103 diverse E. coli strains with available WGS data, including those associated with past foodborne illnesses, to determine robustness and accuracy. The array was able to accurately identify the molecular O and H serotypes, potentially correcting serological failures and providing better resolution for H-nontypeable/nonmotile phenotypes. In addition, molecular risk assessment was possible with key virulence marker identifications. Epidemiologically, each strain had a unique comparative genomic fingerprint that was extended to an additional 507 food and clinical isolates. Finally, a 99.7% phylogenetic concordance was established between microarray analysis and WGS using SNP-level data for advanced genome typing. Our study demonstrates FDA-ECID as a powerful tool for epidemiology and molecular risk assessment with the capacity to profile the global landscape and diversity of E. coli. IMPORTANCE This study describes a robust, state-of-the-art platform developed from available

  4. OpenSlide: A vendor-neutral software foundation for digital pathology

    PubMed Central

    Goode, Adam; Gilbert, Benjamin; Harkes, Jan; Jukic, Drazen; Satyanarayanan, Mahadev

    2013-01-01

    Although widely touted as a replacement for glass slides and microscopes in pathology, digital slides present major challenges in data storage, transmission, processing and interoperability. Since no universal data format is in widespread use for these images today, each vendor defines its own proprietary data formats, analysis tools, viewers and software libraries. This creates issues not only for pathologists, but also for interoperability. In this paper, we present the design and implementation of OpenSlide, a vendor-neutral C library for reading and manipulating digital slides of diverse vendor formats. The library is extensible and easily interfaced to various programming languages. An application written to the OpenSlide interface can transparently handle multiple vendor formats. OpenSlide is in use today by many academic and industrial organizations world-wide, including many research sites in the United States that are funded by the National Institutes of Health. PMID:24244884

  5. Robust fuzzy control for stochastic Markovian jumping systems via sliding mode method

    NASA Astrophysics Data System (ADS)

    Chen, Bei; Jia, Tinggang; Niu, Yugang

    2016-07-01

    This paper considers the problem of sliding mode control for stochastic Markovian jumping systems by means of fuzzy method. The Takagi-Sugeno (T-S) fuzzy stochastic model subject to state-dependent noise is presented. A key feature in this work is to remove the restricted condition that each local system model had to share the same input channel, which is usually assumed in some existing results. The integral sliding surface is constructed for every mode and the connections among various sliding surfaces are established via a set of coupled matrices. Moreover, the present sliding mode controller including the transition rates of modes can cope with the effect of Markovian switching. It is shown that both the reachability of sliding surfaces and the stability of sliding mode dynamics can be ensured. Finally, numerical simulation results are given.

  6. The effects of wall slide and sling slide exercises on scapular alignment and pain in subjects with scapular downward rotation

    PubMed Central

    Kim, Tae-Ho; Lim, Jin-Yong

    2016-01-01

    [Purpose] The present study was performed to evaluate the changes in the scapular alignment, pressure pain threshold and pain in subjects with scapular downward rotation after 4 weeks of wall slide exercise or sling slide exercise. [Subjects and Methods] Twenty-two subjects with scapular downward rotation participated in this study. The alignment of the scapula was measured using radiographic analysis (X-ray). Pain and pressure pain threshold were assessed using visual analogue scale and digital algometer. Patients were assessed before and after a 4 weeks of exercise. [Results] In the within-group comparison, the wall slide exercise group showed significant differences in the resting scapular alignment, pressure pain threshold, and pain after four weeks. The between-group comparison showed that there were significant differences between the wall slide group and the sling slide group after four weeks. [Conclusion] The results of this study found that the wall slide exercise may be effective at reducing pain and improving scapular alignment in subjects with scapular downward rotation. PMID:27799716

  7. User attitudes in analyzing digital slides in a quality control test bed: a preliminary study.

    PubMed

    Della Mea, Vincenzo; Demichelis, Francesca; Viel, Federico; Dalla Palma, Paolo; Beltrami, Carlo Alberto

    2006-05-01

    The pathologist examines suitably stained glass slides through a bright field microscope in order to render histopathological or cytological diagnosis by looking at tissues and cells. Glass slides serve as a permanent record of the patient disease. Over the course of a patient's treatment slides may need to be reviewed at other institutions before treatment can commence. Due to their fragile nature a transportable permanent digital facsimile of the glass slide would be ideal. A digital slide is a set of digital images representing the whole slide normally used by the pathologist, or a significant part of it; it is usually made by a large amount of images, up to thousands, which makes its management difficult. The present paper provides a description of the requirements needed to reproduce glass slides and of the available technological equipment, then the features of the two systems we implemented on different hardware are described, together with those of the digital slide viewer. The viewer was evaluated in two experimental test phases, during which user behaviour and diagnostic reports were measured. Digital slides used in the two experiments were acquired with either system. Possible applications of digital slides are then discussed, including undergraduate and professional education, quality control, and image analysis on full samples as well as on tissue microarrays.

  8. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in...

  9. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare Department... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in...

  10. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in...

  11. Smokers’ and Nonsmokers’ Beliefs About Harmful Tobacco Constituents: Implications for FDA Communication Efforts

    PubMed Central

    2014-01-01

    Introduction: Legislation requires the U.S. Food and Drug Administration (FDA) to release information to the public about harmful constituents in tobacco and tobacco smoke. To inform these efforts, we sought to better understand how smokers and nonsmokers think about tobacco constituents. Methods: In October 2012, 300U.S. adults aged 18–66 years completed a cross-sectional Internet survey. The questions focused on 20 harmful tobacco constituents that the FDA has prioritized for communicating with the public. Results: Most participants had heard of 7 tobacco constituents (ammonia, arsenic, benzene, cadmium, carbon monoxide, formaldehyde, and nicotine), but few participants had heard of the others (e.g., acrolein). Few participants correctly understood that many constituents were naturally present in tobacco. Substances that companies add to cigarette tobacco discouraged people from wanting to smoke more than substances that naturally occur in cigarette smoke (p < .001). Ammonia, arsenic, carbon monoxide, and formaldehyde being in cigarettes elicited the most discouragement from smoking. Constituents elicited greater discouragement from wanting to smoke if respondents were nonsmokers (β = −.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; β = .19, p < .05), believed constituents are added to tobacco (β = .14, p < .05), or were older (β = .16, p < .05). Conclusions: Our study found low awareness of most tobacco constituents, with greater concern elicited by additives. Efforts to communicate health risks of tobacco constituents should consider focusing on ones that elicited the most discouragement from smoking. PMID:24151139

  12. Large eddy simulation of the FDA benchmark nozzle for a Reynolds number of 6500.

    PubMed

    Janiga, Gábor

    2014-04-01

    This work investigates the flow in a benchmark nozzle model of an idealized medical device proposed by the FDA using computational fluid dynamics (CFD). It was in particular shown that a proper modeling of the transitional flow features is particularly challenging, leading to large discrepancies and inaccurate predictions from the different research groups using Reynolds-averaged Navier-Stokes (RANS) modeling. In spite of the relatively simple, axisymmetric computational geometry, the resulting turbulent flow is fairly complex and non-axisymmetric, in particular due to the sudden expansion. The resulting flow cannot be well predicted with simple modeling approaches. Due to the varying diameters and flow velocities encountered in the nozzle, different typical flow regions and regimes can be distinguished, from laminar to transitional and to weakly turbulent. The purpose of the present work is to re-examine the FDA-CFD benchmark nozzle model at a Reynolds number of 6500 using large eddy simulation (LES). The LES results are compared with published experimental data obtained by Particle Image Velocimetry (PIV) and an excellent agreement can be observed considering the temporally averaged flow velocities. Different flow regimes are characterized by computing the temporal energy spectra at different locations along the main axis.

  13. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers

    PubMed Central

    Do, Kathy T.

    2015-01-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

  14. Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal.

    PubMed

    Lerner, Herbert; Whang, Joyce; Nipper, Rebecca

    2013-03-01

    Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.

  15. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers.

    PubMed

    Do, Kathy T; Galván, Adriana

    2015-11-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers.

  16. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers.

    PubMed

    Do, Kathy T; Galván, Adriana

    2015-11-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

  17. Robustness and Actuator Bandwidth of MRP-Based Sliding Mode Control for Spacecraft Attitude Control Problems

    NASA Astrophysics Data System (ADS)

    Keum, Jung-Hoon; Ra, Sung-Woong

    2009-12-01

    Nonlinear sliding surface design in variable structure systems for spacecraft attitude control problems is studied. A robustness analysis is performed for regular form of system, and calculation of actuator bandwidth is presented by reviewing sliding surface dynamics. To achieve non-singular attitude description and minimal parameterization, spacecraft attitude control problems are considered based on modified Rodrigues parameters (MRP). It is shown that the derived controller ensures the sliding motion in pre-determined region irrespective of unmodeled effects and disturbances.

  18. Herbaceous Ornamental Plants. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven

    This document, which is one in a series of curriculum materials that has been developed for use in Ohio agricultural education programs, contains 338 black-and-white photographs of a set of color slides and an accompanying script that, together, are intended as an aid in the study and identification of 150 different commercially important…

  19. Automatic 35 mm slide duplicator

    NASA Technical Reports Server (NTRS)

    Seidel, H. F.; Texler, R. E.

    1980-01-01

    Automatic duplicator is readily assembled from conventional, inexpensive equipment and parts. Series of slides can be exposed without operator attention, eliminating considerable manual handling and processing ordinarily required. At end of programmed exposure sequence, unit shuts off and audible alarm signals completion of process.

  20. Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert

    PubMed Central

    Qato, Danya M.; Trivedi, Amal N.; Mor, Vincent; Dore, David D.

    2016-01-01

    Background Responsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly. Objective To compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups. Research Design A cohort study. Subjects Medicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims. Measures Outcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days’ supply for the last rosiglitazone claim during the study period (May 21, 2007–December 31, 2007) using multivariable proportional hazards models. Results More than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio = 0.90; 95% confidence interval, 0.86–0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio = 0.84; 95% confidence interval, 0.81–0.87). There were no observed differences across quintiles of area-level socioeconomic status. Conclusions White race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA’s safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations. PMID:26978569

  1. Diseases of Landscape Ornamentals. Slide Script.

    ERIC Educational Resources Information Center

    Powell, Charles C.; Sydnor, T. Davis

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with recognizing and controlling diseases found on ornamental landscape plants. Included in the script are narrations for use with a total of 80 slides illustrating various foliar diseases (anthracnose, black spot, hawthorn leaf blight,…

  2. Linear Classification of Dairy Cattle. Slide Script.

    ERIC Educational Resources Information Center

    Sipiorski, James; Spike, Peter

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with principles of the linear classification of dairy cattle. Included in the guide are narrations for use with 63 slides, which illustrate the following areas that are considered in the linear classification system: stature, strength,…

  3. Approved Practices in Dairy Reproduction. Slide Script.

    ERIC Educational Resources Information Center

    Roediger, Roger D.; Barr, Harry L.

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with approved practices in dairy reproduction. Included in the guide are narrations for use with 200 slides dealing with the following topics: the importance of good reproduction, the male and female roles in reproduction, selection of…

  4. A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions

    PubMed Central

    Briesacher, Becky A.; Soumerai, Stephen B.; Zhang, Fang; Toh, Sengwee; Andrade, Susan E.; Wagner, Joann L.; Shoaibi, Azadeh; Gurwitz, Jerry H.

    2013-01-01

    Purpose To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions, and identify best practices for future evaluations. Methods We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity, and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. Results We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. Conclusions Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies. PMID:23847020

  5. Grain boundary sliding behaviour of copper and alpha brass at intermediate temperatures

    NASA Technical Reports Server (NTRS)

    Raj, S. V.

    1991-01-01

    The role of grain boundary sliding in copper and Cu-30 pct Zn in the temperature range 0.50-0.72 Tm, where Tm is the absolute melting point of the material, is examined. First, sliding data obtained on these materials are presented. The results indicate that the stress exponent for sliding is similar to that for lattice deformation, while the activation energy for sliding varies between 0.5 and 1.6 of the activation energy for creep. Several models proposed for grain boundary sliding are discussed, and it is shown that they do not account for the observed results on copper and alpha brass. A phenomenological model is proposed, where it is assumed that grain boundary sliding results from the glide of dislocations on secondary slip planes.

  6. A new optimal sliding mode controller design using scalar sign function.

    PubMed

    Singla, Mithun; Shieh, Leang-San; Song, Gangbing; Xie, Linbo; Zhang, Yongpeng

    2014-03-01

    This paper presents a new optimal sliding mode controller using the scalar sign function method. A smooth, continuous-time scalar sign function is used to replace the discontinuous switching function in the design of a sliding mode controller. The proposed sliding mode controller is designed using an optimal Linear Quadratic Regulator (LQR) approach. The sliding surface of the system is designed using stable eigenvectors and the scalar sign function. Controller simulations are compared with another existing optimal sliding mode controller. To test the effectiveness of the proposed controller, the controller is implemented on an aluminum beam with piezoceramic sensor and actuator for vibration control. This paper includes the control design and stability analysis of the new optimal sliding mode controller, followed by simulation and experimental results. The simulation and experimental results show that the proposed approach is very effective.

  7. Planning Robotic Manipulation Strategies for Sliding Objects

    NASA Astrophysics Data System (ADS)

    Peshkin, Michael A.

    Automated planning of grasping or manipulation requires an understanding of both the physics and the geometry of manipulation, and a representation of that knowledge which facilitates the search for successful strategies. We consider manipulation on a level conveyor belt or tabletop, on which a part may slide when touched by a robot. Manipulation plans for a given part must succeed in the face of two types of uncertainty: that of the details of surfaces in contact, and that of the initial configuration of the part. In general the points of contact between the part and the surface it slides on will be unknown, so the motion of the part in response to a push cannot be predicted exactly. Using a simple variational principle (which is derived), we find the set of possible motions of a part for a given push, for all collections of points of contact. The answer emerges as a locus of centers of rotation (CORs). Manipulation plans made using this locus will succeed despite unknown details of contact. Results of experimental tests of the COR loci are presented. Uncertainty in the initial configuration of a part is usually also present. To plan in the presence of uncertainty, configuration maps are defined, which map all configurations of a part before an elementary operation to all possible outcomes, thus encapsulating the physics and geometry of the operation. The configuration map for an operation sequence is a product of configuration maps of elementary operations. Using COR loci we compute configuration maps for elementary sliding operations. Appropriate search techniques are applied to find operation sequences which succeed in the presence of uncertainty in the initial configuration and unknown details of contact. Such operation sequences may be used as parts feeder designs or as manipulation or grasping strategies for robots. As an example we demonstrate the automated design of a class of passive parts feeders consisting of multiple sequential fences across a conveyor

  8. Finite-time control of DC-DC buck converters via integral terminal sliding modes

    NASA Astrophysics Data System (ADS)

    Chiu, Chian-Song; Shen, Chih-Teng

    2012-05-01

    This article presents novel terminal sliding modes for finite-time output tracking control of DC-DC buck converters. Instead of using traditional singular terminal sliding mode, two integral terminal sliding modes are introduced for robust output voltage tracking of uncertain buck converters. Different from traditional sliding mode control (SMC), the proposed controller assures finite convergence time for the tracking error and integral tracking error. Furthermore, the singular problem in traditional terminal SMC is removed from this article. When considering worse modelling, adaptive integral terminal SMC is derived to guarantee finite-time convergence under more relaxed stability conditions. In addition, several experiments show better start-up performance and robustness.

  9. Dynamic output feedback sliding mode control for uncertain mechanical systems without velocity measurements.

    PubMed

    Chang, Jeang-Lin

    2010-04-01

    For MIMO mechanical systems using position measurements only, this paper presents a dynamic output feedback sliding mode control algorithm in which an additional dynamics is introduced into the design of the sliding surface. Although the system has the mismatched uncertainty and external disturbance, once the system is in the sliding mode, the proposed method can guarantee robust stabilization and sustain the nature of performing disturbance attenuation through utilizing H(infinity) control analytical technique. A controller is then designed to drive the system to the sliding surface in a finite time and stay on it thereafter. Finally, a numerical example is explained for demonstrating the applicability of the proposed scheme.

  10. Pressure vessel sliding support unit and system using the sliding support unit

    DOEpatents

    Breach, Michael R.; Keck, David J.; Deaver, Gerald A.

    2013-01-15

    Provided is a sliding support and a system using the sliding support unit. The sliding support unit may include a fulcrum capture configured to attach to a support flange, a fulcrum support configured to attach to the fulcrum capture, and a baseplate block configured to support the fulcrum support. The system using the sliding support unit may include a pressure vessel, a pedestal bracket, and a plurality of sliding support units.

  11. Optimal sliding guidance algorithm for Mars powered descent phase

    NASA Astrophysics Data System (ADS)

    Wibben, Daniel R.; Furfaro, Roberto

    2016-02-01

    Landing on large planetary bodies (e.g. Mars) with pinpoint accuracy presents a set of new challenges that must be addressed. One such challenge is the development of new guidance algorithms that exhibit a higher degree of robustness and flexibility. In this paper, the Zero-Effort-Miss/Zero-Effort-Velocity (ZEM/ZEV) optimal sliding guidance (OSG) scheme is applied to the Mars powered descent phase. This guidance algorithm has been specifically designed to combine techniques from both optimal and sliding control theories to generate an acceleration command based purely on the current estimated spacecraft state and desired final target state. Consequently, OSG yields closed-loop trajectories that do not need a reference trajectory. The guidance algorithm has its roots in the generalized ZEM/ZEV feedback guidance and its mathematical equations are naturally derived by defining a non-linear sliding surface as a function of the terms Zero-Effort-Miss and Zero-Effort-Velocity. With the addition of the sliding mode and using Lyapunov theory for non-autonomous systems, one can formally prove that the developed OSG law is globally finite-time stable to unknown but bounded perturbations. Here, the focus is on comparing the generalized ZEM/ZEV feedback guidance with the OSG law to explicitly demonstrate the benefits of the sliding mode augmentation. Results show that the sliding guidance provides a more robust solution in off-nominal scenarios while providing similar fuel consumption when compared to the non-sliding guidance command. Further, a Monte Carlo analysis is performed to examine the performance of the OSG law under perturbed conditions.

  12. Automated single-slide staining device

    NASA Technical Reports Server (NTRS)

    Wilkins, J. R.; Mills, S. M. (Inventor)

    1977-01-01

    A simple apparatus and method is disclosed for making individual single Gram stains on bacteria inoculated slides to assist in classifying bacteria in the laboratory as Gram-positive or Gram-negative. The apparatus involves positioning a single inoculated slide in a stationary position and thereafter automatically and sequentially flooding the slide with increments of a primary stain, a mordant, a decolorizer, a counterstain and a wash solution in a sequential manner without the individual lab technician touching the slide and with minimum danger of contamination thereof from other slides.

  13. Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

    PubMed

    O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah

    2016-08-01

    In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed. PMID:27414000

  14. Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

    PubMed

    O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah

    2016-08-01

    In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.

  15. Surface layer structure of AISI 1020 steel at different stages of dry sliding under electric current of high density

    NASA Astrophysics Data System (ADS)

    Aleutdinov, K. A.; Rubtsov, V. Ye; Fadin, V. V.; Aleutdinova, M. I.

    2016-02-01

    Wear intensity of the sliding electric contact steel 1020/steel 1045 depending on sliding time is presented at the contact current density higher than 100 A/cm2 without lubricant. It is shown that wear intensity of 1020 steel decreases at increasing of sliding time. Wear intensity is stabilized after some sliding time. This time (burn-in time) decreases at reduction of current density. Structural changes are realized in surface layer. Signs of liquid phase are observed on sliding surface. This liquid isn't a result of melting. It is established using Auger spectrometry that the contact layer contains up to 50 at.% of oxygen.

  16. Optoelectronic hit/miss transform for screening cervical smear slides

    NASA Astrophysics Data System (ADS)

    Narayanswamy, R.; Turner, R. M.; McKnight, D. J.; Johnson, K. M.; Sharpe, J. P.

    1995-06-01

    An optoelectronic morphological processor for detecting regions of interest (abnormal cells) on a cervical smear slide using the hit/miss transform is presented. Computer simulation of the algorithm tested on 184 Pap-smear images provided 95% detection and 5% false alarm. An optoelectronic implementation of the hit/miss transform is presented, along with preliminary experimental results.

  17. Apparatus Would Stain Microscope Slides

    NASA Technical Reports Server (NTRS)

    Breeding, James D.

    1993-01-01

    Proposed apparatus meters specific amounts of fluid out of containers at specific times to stain microscope slides. Intended specifically for semiautomated staining of microbiological and hematological samples in microgravity, leakproof apparatus used in other environments in which technicians have little time to allocate to staining procedures and/or exposure to toxic staining agents or to micro-organisms to be stained hazardous. Apparatus adapted to perform almost any staining procedure and accommodates multiple staining reagents, useful for small or remote clinical laboratories.

  18. A frictional sliding algorithm for liquid droplets

    NASA Astrophysics Data System (ADS)

    Sauer, Roger A.

    2016-08-01

    This work presents a new frictional sliding algorithm for liquid menisci in contact with solid substrates. In contrast to solid-solid contact, the liquid-solid contact behavior is governed by the contact line, where a contact angle forms and undergoes hysteresis. The new algorithm admits arbitrary meniscus shapes and arbitrary substrate roughness, heterogeneity and compliance. It is discussed and analyzed in the context of droplet contact, but it also applies to liquid films and solids with surface tension. The droplet is modeled as a stabilized membrane enclosing an incompressible medium. The contact formulation is considered rate-independent such that hydrostatic conditions apply. Three distinct contact algorithms are needed to describe the cases of frictionless surface contact, frictionless line contact and frictional line contact. For the latter, a predictor-corrector algorithm is proposed in order to enforce the contact conditions at the contact line and thus distinguish between the cases of advancing, pinning and receding. The algorithms are discretized within a monolithic finite element formulation. Several numerical examples are presented to illustrate the numerical and physical behavior of sliding droplets.

  19. A school nurse's guide to PowerPoint presentations.

    PubMed

    Nowak, Marian; Sayers, Pat; Ashton, Kathleen

    2014-07-01

    In today's educational environment, school nurses are often called upon to provide presentations utilizing electronic slides. A tool frequently utilized for presentations is PowerPoint. However, as with any instructional method, it is only as effective as the presenter who has designed the slides. A study conducted to evaluate professional PowerPoint slides is the focus of this article. After reviewing 1,732 slides and comparing them to best practices criteria, the researchers call attention to common errors in slide presentations. Additionally, the article provides guidance to school nurses in reinventing the art of providing powerful, interactive, and interesting presentations. PMID:25141452

  20. Wide-field lensfree imaging of tissue slides

    NASA Astrophysics Data System (ADS)

    Morel, Sophie Nhu An; Delon, Antoine; Blandin, Pierre; Bordy, Thomas; Cioni, Olivier; Hervé, Lionel; Fromentin, Catherine; Dinten, Jean-Marc; Allier, Cédric

    2015-07-01

    We developed a new imaging tool that can help pathologists in recording wide-field images of tissue slides. We present a simple cost-effective lens-free imaging method to record 2-4μm resolution wide-field (10 mm2 - 6 cm2) images of stained and unstained tissue slides. To our knowledge, our method is the first technique that enables fast (less than 5 minutes) wide-field lens-free imaging of such dense samples. Multiple holograms are recorded with different wavelength illumination, and a multispectral algorithm is used to retrieve both amplitude and phase. Our method can be used to retrieve images of stained tissue slides. For such absorbing object, the useful information is included in the modulus of the reconstructed complex field. Our method can also be applied to retrieve images of unstained tissue slides, where the useful information is in the retrieved phase. This technique is much cheaper and compact than a conventional microscope and could be made portable. Moreover, it enables wide field unstained tissue slides imaging, which could quickly provide useful information, for example on frozen section biopsies, when a rapid diagnosis is needed during surgery.

  1. Digital and traditional slides for teaching cellular morphology: a comparative analysis of learning outcomes.

    PubMed

    Solberg, Brooke L

    2012-01-01

    Recent advances in technology have brought forth an intriguing new tool for teaching hematopoietic cellular identification skills: the digital slide. Although digitized slides offer a number of appealing options for educators, little research has been done to examine how their utilization would impact learning outcomes. To fill that void, this study was designed to examine student performance, skill retention and transferability, and self-efficacy beliefs amongst undergraduate MLS students learning cellular morphology with digital versus traditional slides. Results showed that students learning with digital slides performed better on assessments containing only traditional slide specimens than students learning with traditional slides, both immediately following the learning activity and after a considerable duration of time. Students learning with digital slides also reported slightly higher levels of self-efficacy related to cellular identification. The findings of this study suggest that students learning cellular identification skills with digital slides are able to transfer that skill directly to traditional slides, and that their ability to identify cells is not negatively affected in present or future settings.

  2. FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.

    PubMed

    Welle, Cristin; Krauthamer, Victor

    2012-03-01

    The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4].

  3. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: Food and Drug... the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current... nanotechnology. The points to consider are intended to be broadly applicable to all FDA-regulated products,...

  4. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  5. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... regulated firms to conduct recalls. Variables in the type of products, the quantity and level of... Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... reporting requirements on FDA recalls. DATES: Submit either electronic or written comments on the...

  6. FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough

    MedlinePlus

    ... Home For Consumers Consumer Updates FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough ... that FDA studies will continue. “We enjoy the science,” says Merkel. “But what’s driving our research is ...

  7. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How does FDA define key terms and phrases in this... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in this... device as these terms are defined under this section. Combination product has the meaning set forth...

  8. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  9. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  10. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  11. FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers, 2000.

    ERIC Educational Resources Information Center

    Food and Drug Administration (DHHS/PHS), Rockville, MD.

    This document provides information, standards, and behavioral objectives for standardization and certification of retail food inspection personnel in the Food and Drug Administration (FDA). The procedures described in the document are based on the FDA Food Code, updated to reflect current Food Code provisions and to include a more refined focus on…

  12. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false When does FDA have to issue a decision on an... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

  13. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What criteria does FDA use to order a detention? 1... GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or...

  14. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false When does FDA have to issue a decision on an... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

  15. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false When must prior notice be submitted to FDA? 1.279... GENERAL ENFORCEMENT REGULATIONS Prior Notice of Imported Food Requirements to Submit Prior Notice of Imported Food § 1.279 When must prior notice be submitted to FDA? (a) Except as provided in paragraph...

  16. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY: Food and... Generic Drug User Fee Act of 2008 (AGDUFA). DATES: Submit either electronic or written comments on the... appropriate, and other forms of information technology. FDA Form 3728, Animal Generic Drug User Fee Act...

  17. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  18. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal... Marine Environmental Science Consortium-Dauphin Island Sea Lab (DISL) will greatly contribute to FDA's... Objectives FDA Gulf Coast Seafood Laboratory (GCSL) and the Marine Environmental Science Consortium of...

  19. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and revises the March 2007 guidance entitled ``Drug Safety Information-- FDA's Communication to the Public.''...

  20. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  1. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  2. The FDA Perspective on Pre-Clinical Testing for High Intensity Focused Ultrasound Devices

    NASA Astrophysics Data System (ADS)

    Harris, Gerald R.

    2006-05-01

    In the U. S., the pre-market review of high intensity focused ultrasound (HIFU) devices is carried out under the authority of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act. Different regulatory mechanisms may apply depending on the complexity of the HIFU device and the indications for use, but in all cases pre-clinical testing is required. This testing typically includes ultrasound field characterization, thermal modeling and measurement, and may include demonstrating the accuracy of targeting and monitoring, if applicable. Because there are no guidance documents or standards for these tests at present, the U.S. Food and Drug Administration (FDA) welcomes working with interested parties to develop acceptable procedures that can be incorporated into the regulatory review process.

  3. An Antique Microscope Slide Brings the Thrill of Discovery into a Contemporary Biology Classroom

    ERIC Educational Resources Information Center

    Reiser, Frank

    2012-01-01

    The discovery of a Victorian-era microscope slide titled "Grouped Flower Seeds" began an investigation into the scientific and historical background of the antique slide to develop its usefulness as a multidisciplinary tool for PowerPoint presentations usable in contemporary biology classrooms, particularly large-enrollment sections. The resultant…

  4. "Discoveries in Planetary Sciences": Slide Sets Highlighting New Advances for Astronomy Educators

    NASA Astrophysics Data System (ADS)

    Brain, David; Schneider, N.; Molaverdikhani, K.; Afsharahmadi, F.

    2012-10-01

    We present two new features of an ongoing effort to bring recent newsworthy advances in planetary science to undergraduate lecture halls. The effort, called 'Discoveries in Planetary Sciences', summarizes selected recently announced discoveries that are 'too new for textbooks' in the form of 3-slide PowerPoint presentations. The first slide describes the discovery, the second slide discusses the underlying planetary science concepts at a level appropriate for students of 'Astronomy 101', and the third presents the big picture implications of the discovery. A fourth slide includes links to associated press releases, images, and primary sources. This effort is generously sponsored by the Division for Planetary Sciences of the American Astronomical Society, and the slide sets are available at http://dps.aas.org/education/dpsdisc/ for download by undergraduate instructors or any interested party. Several new slide sets have just been released, and we summarize the topics covered. The slide sets are also being translated into languages other than English (including Spanish and Farsi), and we will provide an overview of the translation strategy and process. Finally, we will present web statistics on how many people are using the slide sets, as well as individual feedback from educators.

  5. The US FDA and animal cloning: risk and regulatory approach.

    PubMed

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

  6. The FDA role in contact lens development and safety.

    PubMed

    Lippman, R E

    1990-01-01

    The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2189684

  7. The FDA and genetic testing: improper tools for a difficult problem

    PubMed Central

    Willmarth, Kirk

    2015-01-01

    The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.

  8. High current density, cryogenically cooled sliding electrical joint development

    SciTech Connect

    Murray, H.

    1986-09-01

    In the past two years, conceptual designs for fusion energy research devices have focussed on compact, high magnetic field configurations. The concept of sliding electrical joints in the large magnets allows a number of technical advantages including enhanced mechanical integrity, remote maintainability, and reduced project cost. The rationale for sliding electrical joints is presented. The conceptual configuration for this generation of experimental devices is highlghted by an approx. 20 T toroidal field magnet with a flat top conductor current of approx. 300 kA and a sliding electrical joint with a gross current density of approx. 0.6 kA/cm/sup 2/. A numerical model was used to map the conductor current distribution as a function of time and position in the conductor. A series of electrical joint arrangements were produced against the system code envelope constraints for a specific version of the Ignition Studies Project (ISP) which is designated as 1025.

  9. The Edison Environmental Center Permeable Pavement Site - slides

    EPA Science Inventory

    This is a presentation for a second Community Outreach Event called "Chemistry Works!" at West Windsor Public Library on Saturday, November 5th. It will review the permeable pavement research project at the Edison Environmental center. Besides slide persentation, two demo units w...

  10. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

    PubMed

    Arpinelli, Fabio; Bamfi, Francesco

    2006-01-01

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs. PMID:17076891

  11. AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers.

    PubMed

    Lowes, Steve; Ackermann, Bradley L

    2016-02-01

    Crystal City VI Workshop on Bioanalytical Method Validation of Biomarkers, Renaissance Baltimore Harborplace Hotel, Baltimore, MD, USA, 28-29 September 2015 The Crystal City VI workshop was organized by the American Association of Pharmaceutical Scientists in association with the US FDA to continue discussion on the bioanalysis of biomarkers. An outcome of the Crystal City V workshop, convened following release of the draft FDA Guidance for Industry on Bioanalytical Methods Validation in 2013 was the need to have further discussion on biomarker methods. Biomarkers ultimately became the sole focal point for Crystal City VI, a meeting attended by approximately 200 people and composed of industry scientists and regulators from around the world. The meeting format included several panel discussions to maximize the opportunity for dialogue among participants. Following an initial session on the general topic of biomarker assays and intended use, more focused sessions were held on chromatographic (LC-MS) and ligand-binding assays. In addition to participation by the drug development community, significant representation was present from clinical testing laboratories. The experience of this latter group, collectively identified as practitioners of CLIA (Clinical Laboratory Improvement Amendments), helped shape the discussion and takeaways from the meeting. While the need to operate within the framework of the current BMV guidance was clearly acknowledged, a general understanding that biomarker methods validation cannot be adequately depicted by current PK-centric guidelines emerged as a consensus from the meeting. This report is not intended to constitute the official proceedings from Crystal City VI, which is expected to be published in early 2016. PMID:26795584

  12. 3D DEM analyses of the 1963 Vajont rock slide

    NASA Astrophysics Data System (ADS)

    Boon, Chia Weng; Houlsby, Guy; Utili, Stefano

    2013-04-01

    The 1963 Vajont rock slide has been modelled using the distinct element method (DEM). The open-source DEM code, YADE (Kozicki & Donzé, 2008), was used together with the contact detection algorithm proposed by Boon et al. (2012). The critical sliding friction angle at the slide surface was sought using a strength reduction approach. A shear-softening contact model was used to model the shear resistance of the clayey layer at the slide surface. The results suggest that the critical sliding friction angle can be conservative if stability analyses are calculated based on the peak friction angles. The water table was assumed to be horizontal and the pore pressure at the clay layer was assumed to be hydrostatic. The influence of reservoir filling was marginal, increasing the sliding friction angle by only 1.6˚. The results of the DEM calculations were found to be sensitive to the orientations of the bedding planes and cross-joints. Finally, the failure mechanism was investigated and arching was found to be present at the bend of the chair-shaped slope. References Boon C.W., Houlsby G.T., Utili S. (2012). A new algorithm for contact detection between convex polygonal and polyhedral particles in the discrete element method. Computers and Geotechnics, vol 44, 73-82, doi.org/10.1016/j.compgeo.2012.03.012. Kozicki, J., & Donzé, F. V. (2008). A new open-source software developed for numerical simulations using discrete modeling methods. Computer Methods in Applied Mechanics and Engineering, 197(49-50), 4429-4443.

  13. A history of slide rules for blackbody radiation computations

    NASA Astrophysics Data System (ADS)

    Johnson, R. Barry; Stewart, Sean M.

    2012-10-01

    During the Second World War the importance of utilizing detection devices capable of operating in the infrared portion of the electromagnetic spectrum was firmly established. Up until that time, laboriously constructed tables for blackbody radiation needed to be used in calculations involving the amount of radiation radiated within a given spectral region or for other related radiometric quantities. To rapidly achieve reasonably accurate calculations of such radiometric quantities, a blackbody radiation calculator was devised in slide rule form first in Germany in 1944 and soon after in England and the United States. In the immediate decades after its introduction, the radiation slide rule was widely adopted and recognized as a useful and important tool for engineers and scientists working in the infrared field. It reached its pinnacle in the United States in 1970 in a rule introduced by Electro Optical Industries, Inc. With the onset in the latter half of the 1970s of affordable, hand-held electronic calculators, the impending demise of the radiation slide rule was evident. No longer the calculational device of choice, the radiation slide rule all but disappeared within a few short years. Although today blackbody radiation calculations can be readily accomplished using anything from a programmable pocket calculator upwards, with each device making use of a wide variety of numerical approximations to the integral of Planck's function, radiation slide rules were in the early decades of infrared technology the definitive "workhorse" for those involved in infrared systems design and engineering. This paper presents a historical development of radiation slide rules with many versions being discussed.

  14. Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.

    PubMed

    Yim, Seon-Hee; Chung, Yeun-Jun

    2014-12-01

    In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing. PMID:25705152

  15. Dynamical chiral symmetry breaking in sliding nanotubes.

    PubMed

    Zhang, X H; Santoro, G E; Tartaglino, U; Tosatti, E

    2009-03-27

    We discover in simulations of sliding coaxial nanotubes an unanticipated example of dynamical symmetry breaking taking place at the nanoscale. While both nanotubes are perfectly left-right symmetric and nonchiral, a nonzero angular momentum of phonon origin appears spontaneously at a series of critical sliding velocities, in correspondence with large peaks of the sliding friction. The nonlinear equations governing this phenomenon resemble the rotational instability of a forced string. However, several new elements, exquisitely "nano" appear here, with the crucial involvement of umklapp and of sliding nanofriction.

  16. Tape-recorded Lectures With Slide Synchronization

    ERIC Educational Resources Information Center

    Goodhue, D.

    1969-01-01

    Describes "Taped Explanation Slide Synchronization" programs used for individual study or group showing in college zoology. Discusses preparation of programs, class organization, equipment, and costs. (EB)

  17. "Slide less pathology": Fairy tale or reality?

    PubMed

    Indu, M; Rathy, R; Binu, M P

    2016-01-01

    Pathology practice is significantly advanced in various frontiers. Therefore, "slide less digital" pathology will not be a mere imagination in near future. Digitalization of histopathological slides (whole slide imaging [WSI]) is possible with the help of whole slide scanner. The WSI has a positive impact not only in routine practice but also in research field, medical education and bioindustry. Even if digital pathology has definitive advantages, its widespread use is not yet possible. As it is an upcoming technology in our field, this article is aimed to discussessential aspects of WSI. PMID:27601824

  18. Buckman extended: federal preemption of state fraud-on-the-FDA statutes.

    PubMed

    Gaddis, Christine A

    2014-01-01

    A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protection afforded to drug manufacturers in product liability actions if plaintiffs can provide evidence that the drug manufacturer made misrepresentations to the FDA during the process of obtaining marketing approval for the drug. Currently, the federal circuits are in disagreement over whether these state "fraud-on-the-FDA" statutes should be federally preempted. This issue warrants resolution for drug manufacturers, private citizens, and state legislatures. This Comment will discuss the history and role of the FDA's authority in drug and medical device regulation; federal preemption generally and the Supreme Court's decisions that considered whether state law failure to warn claims are federally preempted in the context of drugs and medical devices; the Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, where the Court held that claims that a medical device manufacturer made fraudulent representations to the FDA were federally preempted because such claims interfered with the relationship between the FDA and the entities it regulated, state fraud-on-the-FDA statutory provisions, and the existing circuit split regarding whether those statutes should be federally preempted; the potential resolutions to the circuit split; and will conclude and advocate that the Supreme Court's Buckman holding be applied to federally preempt state fraud-on-the-FDA statutes because such statutes involve the relationship between a federal agency and the entity it regulates and thus undermine the FDA's authority.

  19. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis

    PubMed Central

    Wang, Bo; Franklin, Jessica M.; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron S.

    2016-01-01

    Background Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved (“off-label”) uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. Methods Retrospective, segmented time-series analysis using new prescription claims during 2003–2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone). FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone. Results During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications). Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63). Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79). Conclusions The FDA’s sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency’s expert judgments to clinical practice. PMID:27032095

  20. Ensuring that consumers receive appropriate information from drug ads: what is the FDA's role?

    PubMed

    Waxman, Henry A

    2004-01-01

    The promise of direct-to-consumer (DTC) prescription drug advertisements lies in their potential to educate consumers about medical conditions and the possibility of treatment. But this promise can only be fulfilled if consumers are given clear and accurate information. The responsibility for ensuring that this occurs falls on the Food and Drug Administration (FDA). Recent congressional investigations have indicated that the agency is failing at this task, as FDA enforcement actions against false and misleading ads have declined precipitously in recent years. Other FDA efforts, such as its recently released guidelines on prescription drugs, do not appear to be helpful, potentially confusing consumers more than helping them. PMID:15452002

  1. An analysis of FDA passive surveillance reports of seizures associated with consumption of aspartame.

    PubMed

    Tollefson, L; Barnard, R J

    1992-05-01

    Aspartame, the methyl ester of the dipeptide formed from combining phenylalanine and aspartic acid, was approved by the US Food and Drug Administration (FDA) in July 1981. FDA monitors complaints from consumers and health professionals through the Adverse Reaction Monitoring System, a passive surveillance program FDA has received 251 reports of seizures that have been linked to ingestion of aspartame by consumers. In most cases, information obtained from the complainants' medical records as well as data on consumption patterns, temporal relationships, and challenge tests did not support the claim that the occurrences of the seizures were linked to consumption of aspartame.

  2. Science, law, and politics in FDA's genetically engineered foods policy: scientific concerns and uncertainties.

    PubMed

    Pelletier, David L

    2005-06-01

    The Food and Drug Administration's (FDA's) 1992 policy statement granted genetically engineered foods presumptive GRAS (generally recognized as safe) status. Since then, divergent views have been expressed concerning the scientific support for this policy. This paper examines four sources to better understand the basis for these claims: 1) internal FDA correspondence; 2) reports from the National Academy of Sciences; 3) research funded by US Department of Agriculture from 1981 to 2002; and 4) FDA's proposed rules issued in 2001. These sources reveal that little research has been conducted on unintended compositional changes from genetic engineering. Profiling techniques now make this feasible, but the new debate centers on the functional meaning of compositional changes.

  3. Sliding Wear and Friction Behavior of Fuel Rod Material in Water and Dry State

    NASA Astrophysics Data System (ADS)

    Park, Jin Moo; Kim, Jae Hoon; Jeon, Kyeong Lak; Park, Jun Kyu

    In water cooled reactors, the friction between spacer grid and fuel rod can lead to severe wear and it is an important topic to study. In the present study, sliding wear behavior of zirconium alloy was investigated in water and dry state using the pin-on-disc sliding wear tester. Sliding wear resistance of zirconium alloy against heat treated inconel alloy was examined at room temperature. The parameters in this study were sliding velocity, axial load and sliding distance. The wear characteristics of zirconium alloy was evaluated by friction coefficient, specific wear rate and wear volume. The micro-mechanisms responsible for wear in zirconium alloy were identified to be micro-cutting, micro-pitting, delamination and micro-cracking of deformed surface zone.

  4. Sliding mode output feedback control based on tracking error observer with disturbance estimator.

    PubMed

    Xiao, Lingfei; Zhu, Yue

    2014-07-01

    For a class of systems who suffers from disturbances, an original output feedback sliding mode control method is presented based on a novel tracking error observer with disturbance estimator. The mathematical models of the systems are not required to be with high accuracy, and the disturbances can be vanishing or nonvanishing, while the bounds of disturbances are unknown. By constructing a differential sliding surface and employing reaching law approach, a sliding mode controller is obtained. On the basis of an extended disturbance estimator, a creative tracking error observer is produced. By using the observation of tracking error and the estimation of disturbance, the sliding mode controller is implementable. It is proved that the disturbance estimation error and tracking observation error are bounded, the sliding surface is reachable and the closed-loop system is robustly stable. The simulations on a servomotor positioning system and a five-degree-of-freedom active magnetic bearings system verify the effect of the proposed method.

  5. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What expedited procedures apply when FDA initiates... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  6. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What expedited procedures apply when FDA initiates... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  7. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What expedited procedures apply when FDA initiates... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  8. Real-time deformable registration of multi-modal whole slides for digital pathology.

    PubMed

    Mueller, Dan; Vossen, Dirk; Hulsken, Bas

    2011-01-01

    Digital pathology provides new ways to visualize tissue slides and enables new workflows for analyzing these slides. Analogous to radiology, adjacent tissue sections prepared with different stains or biomarkers (e.g. H&E, IHC, special stains, or ISH; chromogenic or fluorescent) may be seen as different modalities, each representing different structural and/or functional information. Today, the anatomic pathologist views multiple glass slides using an optical microscope and then combines the information in their head to reach a (diagnostic) opinion. Moreover, due to the nature of the slide preparation and digitization process, the tissue and its features do not have the exact same morphology, appearance, or spatial alignment, making it difficult to find the same region on adjacent slides. To address such concerns, this paper presents a method for the spatial alignment of multi-modal whole slide digital microscopy images. To remain practical, the described method employs a two-step registration strategy designed to reduce computation time: the first step computes a B-spline deformable transform on low-resolution images prior to visualization, the second step applies the precomputed transformation only to the high-resolution region currently being viewed. The proposed method is demonstrated using a number of cases comprising H&E and IHC stained slides. These results indicate the feasibility of deformable registration for spatial alignment of multi-modal whole slide digital microscopy images within practical time constraints.

  9. Whole slide imaging: uses and limitations for surgical pathology and teaching.

    PubMed

    Boyce, B F

    2015-07-01

    Advances in computer and software technology and in the quality of images produced by digital cameras together with development of robotic devices that can take glass histology slides from a cassette holding many slides and place them in a conventional microscope for electronic scanning have facilitated the development of whole slide imaging (WSI) systems during the past decade. Anatomic pathologists now have opportunities to test the utility of WSI systems for diagnostic, teaching and research purposes and to determine their limitations. Uses include rendering primary diagnoses from scanned hematoxylin and eosin stained tissues on slides, reviewing frozen section or routine slides from remote locations for interpretation or consultation. Also, WSI can replace physical storage of glass slides with digital images, storing images of slides from outside institutions, presenting slides at clinical or research conferences, teaching residents and medical students, and storing fluorescence images without fading or quenching of the fluorescence signal. Limitations include the high costs of the scanners, maintenance contracts and IT support, storage of digital files and pathologists' lack of familiarity with the technology. Costs are falling as more devices and systems are sold and cloud storage costs drop. Pathologist familiarity with the technology will grow as more institutions purchase WSI systems. The technology holds great promise for the future of anatomic pathology. PMID:25901738

  10. Whole slide imaging: uses and limitations for surgical pathology and teaching.

    PubMed

    Boyce, B F

    2015-07-01

    Advances in computer and software technology and in the quality of images produced by digital cameras together with development of robotic devices that can take glass histology slides from a cassette holding many slides and place them in a conventional microscope for electronic scanning have facilitated the development of whole slide imaging (WSI) systems during the past decade. Anatomic pathologists now have opportunities to test the utility of WSI systems for diagnostic, teaching and research purposes and to determine their limitations. Uses include rendering primary diagnoses from scanned hematoxylin and eosin stained tissues on slides, reviewing frozen section or routine slides from remote locations for interpretation or consultation. Also, WSI can replace physical storage of glass slides with digital images, storing images of slides from outside institutions, presenting slides at clinical or research conferences, teaching residents and medical students, and storing fluorescence images without fading or quenching of the fluorescence signal. Limitations include the high costs of the scanners, maintenance contracts and IT support, storage of digital files and pathologists' lack of familiarity with the technology. Costs are falling as more devices and systems are sold and cloud storage costs drop. Pathologist familiarity with the technology will grow as more institutions purchase WSI systems. The technology holds great promise for the future of anatomic pathology.

  11. A mechanism of stick-slip fault sliding without friction rate dependence and supersonic wave propagation

    NASA Astrophysics Data System (ADS)

    Karachevtseva, Iuliia; Dyskin, Arcady; Pasternak, Elena

    2015-04-01

    Stick-slip sliding is often observed at various scales and in particular in fault sliding and the accompanied seismic events. Stick-slip is conventionally associated with rate-dependent friction, in particular the intermittent change between static and kinetic friction. However the accumulation of elastic energy in the sliding plates on both sides of the fault can produce oscillations in the velocity of sliding even if the friction coefficient is constant. This manifests itself in terms of oscillations in the sliding velocity somewhat resembling the stick-slip movement. Furthermore, over long faults the sliding exhibits wave-like propagation. We present a model that shows that the zones of non-zero sliding velocities propagate along the fault with the velocity of p-wave. The mechanism of such fast wave propagation is the normal (tensile/compressive) stresses in the neighbouring elements (normal stresses on the planes normal to the fault surface). The strains associated with these stresses are controlled by the Young's modulus rather than shear modulus resulting in the p-wave velocity of propagation of the sliding zone. This manifests itself as a supersonic (with respect to the s-waves) propagation of an apparent shear rupture.

  12. Triggering mechanism and tsunamogenic potential of the Cape Fear Slide complex, U.S. Atlantic margin

    USGS Publications Warehouse

    Hornbach, Matthew J.; Lavier, Luc L.; Ruppel, Carolyn D.

    2007-01-01

    Analysis of new multibeam bathymetry data and seismic Chirp data acquired over the Cape Fear Slide complex on the U.S. Atlantic margin suggests that at least 5 major submarine slides have likely occurred there within the past 30,000 years, indicating that repetitive, large-scale mass wasting and associated tsunamis may be more common in this area than previously believed. Gas hydrate deposits and associated free gas as well as salt tectonics have been implicated in previous studies as triggers for the major Cape Fear slide events. Analysis of the interaction of the gas hydrate phase boundary and the various generations of slides indicates that only the most landward slide likely intersected the phase boundary and inferred high gas pressures below it. For much of the region, we believe that displacement along a newly recognized normal fault led to upward migration of salt, oversteepening of slopes, and repeated slope failures. Using new constraints on slide morphology, we develop the first tsunami model for the Cape Fear Slide complex. Our results indicate that if the most seaward Cape Fear slide event occurred today, it could produce waves in excess of 2 m at the present-day 100 m bathymetric contour.

  13. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    PubMed

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  14. Use of Cancer-Linked Fibroid Device Declines After FDA Warning

    MedlinePlus

    ... FDA Warning Rate of uterus removals done with power morcellators dropped significantly, study finds To use the ... Aug. 23, 2016 (HealthDay News) -- The use of power morcellators -- cutting tools used in minimally invasive gynecological ...

  15. FDA: Anti-Aging, Skin-Lightening Products May Contain Mercury

    MedlinePlus

    ... FDA: Anti-Aging, Skin-Lightening Products May Contain Mercury How you can eliminate the health risk to ... 3, 2016 (HealthDay News) -- Some skin products contain mercury and pose a threat to your health, the ...

  16. US FDA patient-reported outcome guidance: great expectations and unintended consequences.

    PubMed

    Fehnel, Sheri; DeMuro, Carla; McLeod, Lori; Coon, Cheryl; Gnanasakthy, Ari

    2013-08-01

    Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.

  17. FDA compliance program guidance manual (FY 83). section VI. radiological health

    SciTech Connect

    Not Available

    1982-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration field operations for project implementation.

  18. Indoor Tanning Raises Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products

    MedlinePlus

    ... the FDA make sure indoor tanning facilities are giving truthful and easy-to-read information to consumers. ... a Safer Spring Break More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food ...

  19. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  20. 21 CFR 801.57 - Discontinuation of legacy FDA identification numbers assigned to devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... request for continued use of an assigned labeler code must be submitted by email to: udi@fda.hhs.gov, or... address, email address, and phone number of the labeler who is currently using the labeler code; (2)...

  1. Getting Clever with the Sliding Ladder

    ERIC Educational Resources Information Center

    De, Subhranil

    2014-01-01

    The familiar system involving a uniform ladder sliding against a vertical wall and a horizontal floor is considered again. The floor is taken to be smooth and the wall to be possibly rough--a situation where no matter how large the static friction coefficient between the ladder and the wall, the ladder cannot lean at rest and must slide down.…

  2. The Cancer Digital Slide Archive - TCGA

    Cancer.gov

    Dr. David Gutman and Dr. Lee Cooper developed The Cancer Digital Slide Archive (CDSA), a web platform for accessing pathology slide images of TCGA samples. Find out how they did it and how to use the CDSA website in this Case Study.

  3. Effectively implementing FDA medication alerts utilizing patient centered medical home clinical pharmacists.

    PubMed

    Arenz, Barbara J; Diez, Heidi L; Bostwick, Jolene R; Kales, Helen C; Zivin, Kara; Dalack, Gregory W; Fluent, Tom E; Standiford, Connie J; Stano, Claire; Mi Choe, Hae

    2016-03-01

    FDA medication alerts can be successfully implemented within patient centered medical home (PCMH) clinics utilizing clinical pharmacists. Targeted selection of high-risk patients from an electronic database allows PCMH pharmacists to prioritize assessments. Trusting relationships between PCMH clinical pharmacists and primary care providers facilitates high response rates to pharmacist recommendations. This health system approach led by PCMH pharmacists provides a framework for proactive responses to FDA safety alerts and medication related quality measure improvement. PMID:27001101

  4. FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

    PubMed

    James, J S

    1998-03-01

    The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

  5. Thermal and thermomechanical effects in dry sliding

    NASA Technical Reports Server (NTRS)

    Kennedy, F. E., Jr.

    1984-01-01

    Developments in the study of interrelated thermal and mechanical phenomena in sliding systems are reviewed. The topics reviewed include mechanisms of frictional heating and the distribution of heat during sliding friction, the experimental measurement and analysis of surface and near-surface temperatures resulting from frictional heating, thermal deformation around sliding contacts and the changes in contact geometry caused by thermal deformation and thermoelastic instability, and the thermomechanical stress distribution around the frictionally heated and thermally deformed contact spots. The influence of the thermal and thermomechanical contact phenomena on friction and wear, surface melting, softening, chemical deterioration, and thermocracking are discussed. The phenomena have important implications in the design and application of sliding or sliding-rolling mechanical components such as dynamic seals, brakes, clutches, plastic bearings, solid or boundary-lubricated bearings, and gears.

  6. A Sliding Mode Control with Optimized Sliding Surface for Aircraft Pitch Axis Control System

    NASA Astrophysics Data System (ADS)

    Lee, Sangchul; Kim, Kwangjin; Kim, Youdan

    A sliding mode controller with an optimized sliding surface is proposed for an aircraft control system. The quadratic type of performance index for minimizing the angle of attack and the angular rate of the aircraft in the longitudinal motion is used to design the sliding surface. For optimization of the sliding surface, a Hamilton-Jacobi-Bellman (HJB) equation is formulated and it is solved through a numerical algorithm using a Generalized HJB (GHJB) equation and the Galerkin spectral method. The solution of this equation denotes a nonlinear sliding surface, on which the trajectory of the system approximately satisfies the optimality condition. Numerical simulation is performed for a nonlinear aircraft model with an optimized sliding surface and a simple linear sliding surface. The simulation result demonstrates that the proposed controller can be effectively applied to the longitudinal maneuver of an aircraft.

  7. Sliding mode control with PID sliding surface and experimental application to an electromechanical plant.

    PubMed

    Eker, Ilyas

    2006-01-01

    In this study, a sliding mode control system with a proportional+integral+derivative (PID) sliding surface is adopted to control the speed of an electromechanical plant. A robust sliding mode controller is derived so that the actual trajectory tracks the desired trajectory despite uncertainty, nonlinear dynamics, and external disturbances. The proposed sliding mode controller is chosen to ensure the stability of overall dynamics during the reaching phase and sliding phase. The stability of the system is guaranteed in the sense of the Lyapunov stability theorem. The chattering problem is overcome using a hyperbolic function for the sliding surface. Experimental results that are compared with the results of conventional PID verify that the proposed sliding mode controller can achieve favorable tracking performance, and it is robust with regard to uncertainties and disturbances.

  8. Sliding Over a Phase Transition

    NASA Astrophysics Data System (ADS)

    Tosatti, Erio; Benassi, Andrea; Vanossi, Andrea; Santoro, Giuseppe E.

    2011-03-01

    The frictional response experienced by a stick-slip slider when a phase transition occurs in the underlying solid substrate is a potentially exciting, poorly explored problem. We show, based on 2-dimensional simulations modeling the sliding of a nanotip, that indeed friction may be heavily affected by a continuous structural transition. First, friction turns nonmonotonic as temperature crosses the transition, peaking at the critical temperature Tc where fluctuations are strongest. Second, below Tc friction depends upon order parameter directions, and is much larger for those where the frictional slip can cause a local flip. This may open a route towards control of atomic scale friction by switching the order parameter direction by an external field or strain, with possible application to e.g., displacive ferroelectrics such as BaTi O3 , as well as ferro- and antiferro-distortive materials. Supported by project ESF FANAS/AFRI sponsored by the Italian Research Council (CNR).

  9. Slide crown lengthening procedure using wide surface incisions and cyanoacrylate.

    PubMed

    Szymaitis, Dennis W

    2011-01-01

    This article introduces the slide crown lengthening procedure (SCLP), which incorporates surgical design features to overcome present crown lengthening procedure (CLP) shortcomings. The result is a 75% decrease in required surgery on adjacent teeth and a corresponding 75% reduction in surgical time. Other advantages include a reduction in surgical morbidity, improvement in terminal esthetics, and fewer teeth subject to papillae removal and apically repositioned gingiva. The 20 to 30 degree incision forming the slide is the pivotal feature; it allows effortless flap positioning. This incision angle enables wide surface incisions to adhere flaps together by producing stronger fibrin clots, decreasing tissue retraction angles, and reforming disrupted fibrin clots as incision sides slide while maintaining contact. This enhanced fibrin clot eliminates the need for sutures. The slide produced by the 20 to 30 degree incision functions for crown lengthening on all sites (facial, lingual, or palatal). This versatile surgical design introduces a new healing dimension that adapts to and provides benefits for other dental surgeries, such as gingival grafts, endodontic surgery, implants, and extractions.

  10. 3D finite element modeling of sliding wear

    NASA Astrophysics Data System (ADS)

    Buentello Hernandez, Rodolfo G.

    Wear is defined as "the removal of material volume through some mechanical process between two surfaces". There are many mechanical situations that can induce wear and each can involve many wear mechanisms. This research focuses on the mechanical wear due to dry sliding between two surfaces. Currently there is a need to identify and compare materials that would endure sliding wear under severe conditions such as high velocities. The high costs associated with the field experimentation of systems subject to high-speed sliding, has prevented the collection of the necessary data required to fully characterize this phenomena. Simulating wear through Finite Elements (FE) would enable its prediction under different scenarios and would reduce experimentation costs. In the aerospace, automotive and weapon industries such a model can aid in material selection, design and/or testing of systems subjected to wear in bearings, gears, brakes, gun barrels, slippers, locomotive wheels, or even rocket test tracks. The 3D wear model presented in this dissertation allows one to reasonably predict high-speed sliding mechanical wear between two materials. The model predictions are reasonable, when compared against those measured on a sled slipper traveling over the Holloman High Speed Tests Track. This slipper traveled a distance of 5,816 meters in 8.14 seconds and reached a maximum velocity of 1,530 m/s.

  11. The debate on FDA reform: a view from the U.S. Senate. Food and Drug Administration.

    PubMed

    Baker, R

    1995-09-01

    The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs.

  12. Reform at FDA: faster access to promising drugs? Food and Drug Administration.

    PubMed

    Baker, R

    1995-06-01

    The Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs, vaccines, and medical devices are safe and effective, is under hot debate by Congress, the Clinton administration, and the AIDS community. The Clinton/Gore proposal favors excluding drug and biologic manufacturers from requirements for more environmental assessments and only indirectly addresses drug development. Oregon Democratic Congressman Ron Wyden introduced an FDA reform bill which calls for the FDA to use expert panels, independent testing organizations, and institutional review boards (IRB) to help speed new drugs and devices through the approval process. The bill calls for the use of the IRB for the approval (or denial) of applications for Phase I review of new drugs. Not surprisingly, the AIDS community has differing views on the reform at the FDA. The Treatment Action Group (TAG), whose members hold key positions in well-known AIDS groups, supports the status quo at FDA and is lobbying AIDS organizations across the country to sign on to its FDA Reform Principles. Other AIDS treatment activists, such as members of ACT UP, favor local IRB jurisdiction over Phase I research.

  13. Assessment of foetal risk associated with 93 non-US-FDA approved medications during pregnancy

    PubMed Central

    Al-jedai, Ahmed H.; Balhareth, Sakra S.; Algain, Roaa A.

    2012-01-01

    Health care practitioners utilize the United States-Food and Drug Administration (US-FDA) pregnancy categorization (A, B, C, D, X) for making decision on the appropriateness of certain medications during pregnancy. Many non US-FDA approved medications are registered and marketed in Saudi Arabia. However, these medications do not have an assigned pregnancy risk categorization like those approved in the US. The objective of this review is to evaluate, report, and categorize the foetal risk associated with non-US-FDA approved medications registered by the Saudi Food and Drug Authority (S-FDA) according to the US-FDA pregnancy risk categorization system. We identified 109 non-US-FDA approved medications in the Saudi National Formulary (SNF) as of October 2007. We searched for data on functional or anatomical birth defects or embryocidal-associated risk using different databases and references. An algorithm for risk assessment was used to determine a pregnancy risk category for each medication. Out of 93 eligible medications, 73% were assigned category risk C, 10 medications (11%) were assigned category risk D, and 12 medications (13%) were assigned category risk B. Only three medications were judged to be safe during pregnancy based on the available evidence and were assigned category risk A. Inconsistencies in defining and reporting the foetal risk category among different drug regulatory authorities could create confusion and affect prescribing. We believe that standardization and inclusion of this information in the medication package insert is extremely important to all health care practitioners. PMID:23960803

  14. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

    PubMed

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. PMID:27068243

  15. Whole slide imaging of unstained tissue using lensfree microscopy

    NASA Astrophysics Data System (ADS)

    Morel, Sophie Nhu An; Hervé, Lionel; Bordy, Thomas; Cioni, Olivier; Delon, Antoine; Fromentin, Catherine; Dinten, Jean-Marc; Allier, Cédric

    2016-04-01

    Pathologist examination of tissue slides provides insightful information about a patient's disease. Traditional analysis of tissue slides is performed under a binocular microscope, which requires staining of the sample and delays the examination. We present a simple cost-effective lensfree imaging method to record 2-4μm resolution wide-field (10 mm2 to 6 cm2) images of unstained tissue slides. The sample processing time is reduced as there is no need for staining. A wide field of view (10 mm2) lensfree hologram is recorded in a single shot and the image is reconstructed in 2s providing a very fast acquisition chain. The acquisition is multispectral, i.e. multiple holograms are recorded simultaneously at three different wavelengths, and a dedicated holographic reconstruction algorithm is used to retrieve both amplitude and phase. Whole tissue slides imaging is obtained by recording 130 holograms with X-Y translation stages and by computing the mosaic of a 25 x 25 mm2 reconstructed image. The reconstructed phase provides a phase-contrast-like image of the unstained specimen, revealing structures of healthy and diseased tissue. Slides from various organs can be reconstructed, e.g. lung, colon, ganglion, etc. To our knowledge, our method is the first technique that enables fast wide-field lensfree imaging of such unlabeled dense samples. This technique is much cheaper and compact than a conventional phase contrast microscope and could be made portable. In sum, we present a new methodology that could quickly provide useful information when a rapid diagnosis is needed, such as tumor margin identification on frozen section biopsies during surgery.

  16. Insights from new high-resolution data from the Traenadjupet Slide on the Norwegian margin

    NASA Astrophysics Data System (ADS)

    Mozzato, Alessandro; Tappin, David; Talling, Peter; Cartigny, Matthieu; Long, David; Hunt, James; Watts, Camilla; Pope, Ed; Allin, Joshua; Stanford, Jennifer; Dowdeswell, Julian

    2015-04-01

    Submarine landslides are among the largest mass flows on Earth and can be far larger than landslides on land. They can generate tsunami and therefore represent a significant geohazard. A series of large submarine landslides have been studied previously in unusual detail along the Norwegian continental margin, including the Storegga and Traenadjupet Slides. The most closely studied is the Storegga slide(1,2) which occurred 8.2k BP and moved >3,000 km3 of sediment(2). A tsunami with run up heights sometimes reaching 20m high has been identified from deposits mapped along the Norwegian, Shetland and mainland Scottish coasts (1). The Traenadjupet Slide is the second largest slide on the Norwegian margin with a volume of about 900km3. It has been dated to ~4k BP(3,4). The volume is comparable to that of the Storegga Slide. However, no major tsunami deposit at 4ka has yet been mapped that links to the Traenadjupet Slide (Stein Bondevik, pers. comm.). The purpose of this study is to obtain new insights into how the Traenadjupet Slide was emplaced. In particular, why did movement of 900km3 of sediment during the Traenadjupet Slide fail to produce a major tsunami at 4ka? We present a new field dataset for the Traendajupet Slide including MBES bathymetry, sub-bottom profiles, and piston cores acquired during the 64PE391 research expedition in July 2014, together with data acquired previously during the JCR51 cruise. These datasets cover a large part of Traenadjupet slide and give new insights into the mechanism of the slide failure. The Traenadjupet Slide morphology is very different to that of the Storegga Slide. The Storegga Slide disintegrated generating debris flows and turbidity currents that propagated for hundreds of kilometres. The Traenadjupet Slide, on the other hand, appears not to have disintegrated in a similar manner, but rather left thick mounded deposits at the foot of the slope(5). Several distinct lobes covered with 500m-scale sediment blocks are visible

  17. Time-varying sliding-coefficient-based decoupled terminal sliding-mode control for a class of fourth-order systems.

    PubMed

    Bayramoglu, Husnu; Komurcugil, Hasan

    2014-07-01

    A time-varying sliding-coefficient-based decoupled terminal sliding mode control strategy is presented for a class of fourth-order systems. First, the fourth-order system is decoupled into two second-order subsystems. The sliding surface of each subsystem was designed by utilizing time-varying coefficients. Then, the control target of one subsystem to another subsystem was embedded. Thereafter, a terminal sliding mode control method was utilized to make both subsystems converge to their equilibrium points in finite time. The simulation results on the inverted pendulum system demonstrate that the proposed method exhibits a considerable improvement in terms of a faster dynamic response and lower IAE and ITAE values as compared with the existing decoupled control methods.

  18. Were the Trænadjupet and Nyk Slides multi-staged?

    NASA Astrophysics Data System (ADS)

    Allin, Joshua; Mozzato, Alessandro; Tappin, David; Talling, Peter; Hunt, James

    2016-04-01

    Submarine landslides originating from active and extinct trough mouth fans are some of the largest single mass movements evident on Earth. These landslides are capable of damaging offshore infrastructure and can also trigger far-reaching tsunamis. For these reasons understanding the timing, dynamics, and triggering mechanisms of large submarine landslides is important for regional geohazard assessment. The Trænadjupet Slide occurred 4,000 ca. years ago and originated from the Trænadjupet paleo-ice stream on the Central Norwegian margin. The Trænadjupet Slide partially buried the deposits of a previous slide originating from the same section of the Norwegian margin; the Nyk Slide, which occurred at 16,000 ca years ago. Although the Trænadjupet Slide had an estimated volume of 900 km3 and originated from a shallow water depth, it does not appear to have triggered a tsunami. This is in contrast to the comparably-sized Storegga Slide, which produced a tsunami that devastated coastal areas as far away as Scotland. The apparent absence of a tsunami suggests that the failure dynamics for the Trænadjupet slide were different to that of other large slides along the Norwegian Margin. The deposits of both the Trænadjupet and Nyk Slides consist of several blocky lobes extending out into the Lofoten Basin. The lobate morphology of the deposits may imply that both slides occurred in a number of different and possibly temporally-disparate stages. Importantly, multi-staged failures have a much lower tsunamigenic potential due to the lower initial volume displacement. These staggered failures consisting of smaller sediment volumes might explain why no contemporaneous onshore tsunami deposits are found on nearby coastlines, particularly in the case of the post-glacial Trænadjupet Slide. Here we present a new sediment core dataset collected from the previously un-sampled lobes of the Trænadjupet and Nyk Slides. These cores will help us better characterise the deposit types

  19. The Giant Submarine Alika Debris Slide, Mauna Loa, Hawaii

    NASA Astrophysics Data System (ADS)

    Lipman, Peter W.; Normark, William R.; Moore, James G.; Wilson, John B.; Gutmacher, Christina E.

    1988-05-01

    A 4000-km2 area of submarine slump and slide deposits along the west flank of Mauna Loa volcano has been mapped with GLORIA side-scan sonar images, seismic reflection profiles, and new bathymetry. The youngest deposits are two debris avalanche lobes that travelled from their breakaway area near the present shoreline as much as 100 km into the Hawaiian Deep at water depths of 4800 m. The two lobes partly overlap and together are designated the Alika slide. They were derived from the same source area and probably formed in rapid succession. Distinction hummocky topography, marginal levees, and other features on lower slopes (0.3°-0.6°) of these deposits resemble subaerial volcanic debris avalanche deposits such as 1980 Mount St. Helens and suggest high emplacement velocities. The breakaway area for the Alika slide (10°-15° slopes) is characterized by large block slumps, bounded by normal faults, that probably represent multiple subsidence events before, during, and after the debris avalanches. Lower slopes of the slide contain distinctive lobate-terraced deposits that are interpreted as having been emplaced more slowly, prior to the debris avalanches. Estimated thicknesses of 50-200 m suggest volumes of 200-600 km3 for the two lobes. The combined volume of the entire slide and slump terrane is probably 1500-2000 km3. The slide deposits predate a 13-ka coral reef and probably postdate the block-faulted Ninole Basalt, roughly dated as a few hundred thousand years old. The Alika slide, or a similar deposit recognized on GLORIA images further north along the Hawaiian Ridge, probably triggered a giant wave that washed 325 m high on Lanai at about 100 ka. Slumping on Mauna Loa has been most intense adjacent to the large arcuate bend in its southwest rift zone, as the rift zone migrated westward away from the growing Kilauea volcano. Slumping events were probably triggered by seismic activity accompanying dike injection along the rift zone. Such massive slumps

  20. Towards a Computational Analysis of Status and Leadership Styles on FDA Panels

    NASA Astrophysics Data System (ADS)

    Broniatowski, David A.; Magee, Christopher L.

    Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.

  1. Activity Profile of an FDA-Approved Compound Library against Schistosoma mansoni

    PubMed Central

    Panic, Gordana; Vargas, Mireille; Scandale, Ivan; Keiser, Jennifer

    2015-01-01

    Background As plans to expand mass drug treatment campaigns to fight schistosomiasis form, worries about reliance on praziquantel as the sole available treatment motivate the investigation for novel antischistosomal compounds. Drug repurposing might be an inexpensive and effective source of novel antischistosomal leads. Methodology 1600 FDA approved compounds were first assayed against Schistosoma mansoni schistosomula at a concentration of 10 µM. Active compounds identified from this screen were advanced to the adult worm screen at 33.33 µM, followed by hit characterization. Leads with complementary pharmacokinetic and toxicity profiles were then selected for in vivo studies. Principal Findings The in vitro screen identified 121 and 36 compounds active against the schistosomula and adult stage, respectively. Further, in vitro characterization and comparison with already available pharmacokinetic and toxicity data identified 11 in vivo candidates. Doramectin (10 mg/kg) and clofazimine (400 mg/kg) were found to be active in vivo with worm burden reductions of 60.1% and 82.7%, respectively. Conclusions/Significance The work presented here expands the knowledge of antischistosomal properties of already approved compounds and underscores variations observed between target-based and phenotypic approaches and among laboratories. The two in vivo-active drugs identified in this study, doramectin and clofazimine are widely available and present as novel drug classes as starting points for further investigation. PMID:26230921

  2. Whole slide imaging for educational purposes

    PubMed Central

    Pantanowitz, Liron; Szymas, Janusz; Yagi, Yukako; Wilbur, David

    2012-01-01

    Digitized slides produced by whole slide image scanners can be easily shared over a network or by transferring image files to optical or other data storage devices. Navigation of digitized slides is interactive and intended to simulate viewing glass slides with a microscope (virtual microscopy). Image viewing software permits users to edit, annotate, analyze, and easily share whole slide images (WSI). As a result, WSI have begun to replace the traditional light microscope, offering a myriad of opportunities for education. This article focuses on current applications of WSI in education and proficiency testing. WSI has been successfully explored for graduate education (medical, dental, and veterinary schools), training of pathology residents, as an educational tool in allied pathology schools (e.g., cytotechnology), for virtual tracking and tutoring, tele-education (tele-conferencing), e-learning, virtual workshops, at tumor boards, with interactive publications, and on examinations. WSI supports flexible and cost-effective distant learning and augments problem-oriented teaching, competency evaluation, and proficiency testing. WSI viewed on touchscreen displays and with tablet technology are especially beneficial for education. Further investigation is necessary to develop superior WSI applications that better support education and to design viewing stations with ergonomic tools that improve the WSI-human interface and navigation of virtual slides. Studies to determine the impact of training pathologists without exposure to actual glass slides are also needed. PMID:23372987

  3. STS-80 Post Flight Presentation

    NASA Technical Reports Server (NTRS)

    1996-01-01

    The flight crew of STS-80, Cmdr. Kenneth D. Cockrell, Pilot Kent V. Rominger, Mission Specialists, Tamara E. Jernigan, Thomas D. Jones, and F. Story Musgrave give a post flight presentation of their mission. This presentation is divided into two parts first a slide presentation of still shots, and the second is a video presentation.

  4. Sliding mode pulse-width modulation technique for direct torque controlled induction motor drive

    NASA Astrophysics Data System (ADS)

    Bounadja, M.; Belarbi, A. W.; Belmadani, B.

    2010-05-01

    This paper presents a novel pulse-width modulation technique based sliding mode approach for direct torque control of an induction machine drive. Methodology begins with a sliding mode control of machine's torque and stator flux to generate the reference voltage vector and to reduce parameters sensitivity. Then, the switching control of the three-phase inverter is developed using sliding mode concept to make the system tracking reference voltage inputs. The main features of the proposed methodologies are the high tracking accuracy and the much easier implementation compared to the space vector modulation. Simulations are carried out to confirm the effectiveness of proposed control algorithms.

  5. The Earth surface slide movement at Soledad

    NASA Astrophysics Data System (ADS)

    Moreno, A.

    1986-11-01

    The Earth surface slide movement at Soledad is a mountain-slide type of movement. Estimations of the thickness of the layer which is moving range between 10 and 100 m. There is no proof that the movement is water induced, but it could be influenced by the water household. The slope of the slide area is H: D = 1: 2. The height difference in the moving area studied, according to this paper, is 1 km. The actual rate of movement is about 12 cm/yr.

  6. Increase in friction force with sliding speed

    NASA Astrophysics Data System (ADS)

    Cross, Rod

    2005-09-01

    A block sliding down an inclined plane normally accelerates. However, if the friction force increases with speed, then the block can slide at a constant terminal speed in a manner similar to the fall of an object through a fluid. Measurements of the increase in the coefficient of friction for tennis ball cloth sliding on a smooth surface are described over speeds varying by a factor of 9000. For the low speed measurements, the ball cloth was attached to the bottom of a weighted box and pulled along a horizontal surface by a constant horizontal force. Results at higher speeds were obtained by bouncing a tennis ball off the surface.

  7. XPS analysis of 440C steel surfaces lubricated with perfluoropolyethers under sliding conditions in high vacuum

    NASA Technical Reports Server (NTRS)

    Herrera-Fierro, Pilar; Masuko, Masabumi; Jones, William R., Jr.; Pepper, Stephen V.

    1994-01-01

    This work presents the results of the X-Ray Photoelectron Spectroscopy (XPS) analysis of AISI 440C ball surfaces lubricated with perfluoropolyether (PFPE) oils after friction experiments under sliding conditions at high load in air and vacuum environments. The PFPE lubricants tested were Demnum S100, Fomblin Z-25, and Krytox 143AB. It was found that all the PFPE lubricants were degraded by sliding contact causing the formation of inorganic fluorides on the metallic surfaces and a layer of organic decomposition products. KRYTOX 143AB was the least reactive of the three lubricants tested. It was also found that metal fluoride formed at off-scar areas. This suggests the formation of reactive species, such as COF2 or R(sub f)COF, during sliding experiments, which can diffuse through the lubricant film and react with the metallic surfaces away from the contact region. Comparison of reference specimens before sliding with those that had undergone the sliding tests showed that the amount of non-degraded PFPE remaining on the surface of the balls after the sliding experiments was greater than that of the balls without sliding.

  8. Interfacial dynamnics at sliding Ta/Al interfaces

    NASA Astrophysics Data System (ADS)

    Hammerberg, J. E.; Ravelo, R.; Holian, B. L.; Germann, T. C.; Olson, C. J.

    2002-03-01

    We present results of large-scale MD simulations of sliding Al(100)/Ta(100) interfaces at high shearing velocties. The Ta and Al interactions are modeled using EAM potentials. We discuss the structural evolution near the interface and compare our results with known 2-dimensional simulations which make use of Lennard-Jones potentials but in similar scaled-velocity regimes, namely, 0.01

  9. The new NIH and FDA medical research policies: targeting gender, promoting justice.

    PubMed

    Baird, K L

    1999-06-01

    The National Institutes of Health (NIH) and Food and Drug Administration (FDA) have both recently revised their policies regarding the inclusion of women in clinical trials. Pressured by women's health activists and members of Congress, the NIH has vastly improved its policies; it now requires that women and minorities the included in clinical trials and that an analysis of gender and racial differences be performed. The FDA policy states that women and men should be included in clinical trials if both would receive the drug when marketed and that it expects a gender analysis to be performed. The FDA also lifted its 1977 ban on including women of childbearing potential in the early phases of drug studies. Analyzing these NIH and FDA policies according to a gender justice framework, I find that the NIH has moved significantly toward the institution of gender justice as it applies to medical research policies and that the FDA has taken only small steps toward this goal and lags behind the NIH.

  10. Foam-filled cushions for sliding trays

    NASA Technical Reports Server (NTRS)

    Nahin, S. B.; Robb, P. H.

    1980-01-01

    Polytetrafluoroethylene tube filled with polyurethane foam forms low friction sliding surface that cushions vibrations and absorbs manufacturing tolerances and misalignment. Possible uses include packaging of components for shipping and seals for doors in lockers, cars, and refrigerators.

  11. Sliding scale insulin use: myth or insanity?

    PubMed

    Umpierrez, Guillermo E; Palacio, Andres; Smiley, Dawn

    2007-07-01

    Inpatient hyperglycemia in people with or without diabetes is associated with an increased risk of complications and mortality, a longer hospital stay, a higher admission rate to the intensive care unit, and higher hospitalization costs. Despite increasing evidence that supports intensive glycemic control in hospitalized patients, blood glucose control continues to be challenging, and sliding scale insulin coverage, a practice associated with limited therapeutic success, continues to be the most frequent insulin regimen in hospitalized patients. Sliding scale insulin has been in use for more than 80 years without much evidence to support its use as the standard of care. Several studies have revealed evidence of poor glycemic control and deleterious effects in sliding scale insulin use. To understand its wide use and acceptance, we reviewed the origin, advantages, and disadvantages of sliding scale insulin in the inpatient setting.

  12. Automated single-slide staining system

    NASA Technical Reports Server (NTRS)

    Mills, S. M.; Wilkins, J. R.

    1974-01-01

    Apparatus developed to Gram-stain single slides automatically is flexible enough to accommodate other types of staining procedures. Method frees operator and eliminates necessity for subjective evaluations as to length of staining or decolorizing time.

  13. Variations of the Sliding Ladder Problem

    ERIC Educational Resources Information Center

    Kapranidis, Stelios; Koo, Reginald

    2008-01-01

    This article takes another look at the sliding ladder problem that students meet in the study of related rates in calculus. Physically realistic situations with both constrained and understrained ladders are explored.

  14. The Louisiana Slide Library; A Humanities Program. Bulletin 1755.

    ERIC Educational Resources Information Center

    Louisiana Council for Music and Performing Arts, New Orleans.

    The Louisiana Slide Library is an extensive collection of slides, lectures, and tapes designed for use in the arts, the humanities, social and ethnic studies, languages, home economics, careers, crafts, and special education. This bibliography lists these slide sets and indicates the grade level intended for each set and the number of slides in…

  15. Ornamental Annual Plants and Their Uses. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with ornamental annual plants and their uses. Included in the script are narrations for use with a total of 254 slides illustrating 97 different plants. At least two slides are provided for each plant: one shows the growth habits of the…

  16. Gela submarine slide: gigantic basin-wide event in the Plio-Quaternary foredeep of Sicily

    SciTech Connect

    Argnani, A.; Trincardi, F.

    1988-08-01

    The Gela basin is a Pliocene-Quaternary foredeep basin located at the front of the Maghrebian fold-thrust belt of Sicily, filled with 2,500 m-thick shallowing-upward marine sediments. An important contribution to the basin fill comes from a huge, basin-wide submarine slide which extends for 3,500 km/sup 2/ and thickens as much as 450 m; the estimated sediment volume involved in the slide is close to 1,000 km/sup 3/. The authors investigation used more than 3,000 km of multichannel and single-channel seismic reflection profiles. The slide depositional geometries and facies relationships have been reconstructed from seismic interpretation to provide insight into transport and emplacement mechanisms. Apparently, the slide was not simply deposited via mass transfer from the slope into the basin. Indeed, the bulk of the slide is composed of basin sediments plastically deformed under the gravitational force driven by the correspondent slope sediments. Such a deformation occurred above an extremely effective decollement surface which controlled the slide distribution throughout the basin. More localized decollement planes are, however, present within the slide body and contributed to its complex deformation. The slide can thus be considered the result of a generalized gravitational collapse which affected the sediments lying above a peculiar decollement horizon. A general uplift characterized the late Quaternary evolution of the area, and volcanic activity was quite widespread and documented in the historical record. A punctuated episode of energy release (volcanic related ), superimposed to the uplift trend, may have triggered the slide in conjunction with potentially easy detachment of a decollement.

  17. Compact, Automated Centrifugal Slide-Staining System

    NASA Technical Reports Server (NTRS)

    Feeback, Daniel L.; Clarke, Mark S. F.

    2004-01-01

    The Directional Acceleration Vector-Driven Displacement of Fluids (DAVD-DOF) system, under development at the time of reporting the information for this article, would be a relatively compact, automated, centrifugally actuated system for staining blood smears and other microbiological samples on glass microscope slides in either a microgravitational or a normal Earth gravitational environment. The DAVD-DOF concept is a successor to the centrifuge-operated slide stainer (COSS) concept, which was reported in Slide-Staining System for Microgravity or Gravity (MSC-22949), NASA Tech Briefs, Vol. 25, No. 1 (January, 2001), page 64. The COSS includes reservoirs and a staining chamber that contains a microscope slide to which a biological sample is affixed. The staining chamber is sequentially filled with and drained of staining and related liquids from the reservoirs by use of a weighted plunger to force liquid from one reservoir to another at a constant level of hypergravity maintained in a standard swing-bucket centrifuge. In the DAVD-DOF system, a staining chamber containing a sample would also be sequentially filled and emptied, but with important differences. Instead of a simple microscope slide, one would use a special microscope slide on which would be fabricated a network of very small reservoirs and narrow channels connected to a staining chamber (see figure). Unlike in the COSS, displacement of liquid would be effected by use of the weight of the liquid itself, rather than the weight of a plunger.

  18. Slip and slide method of factoring trinomials with integer coefficients over the integers

    NASA Astrophysics Data System (ADS)

    Donnell, William A.

    2012-06-01

    In intermediate and college algebra courses there are a number of methods for factoring quadratic trinomials with integer coefficients over the integers. Some of these methods have been given names, such as trial and error, reversing FOIL, AC method, middle term splitting method and slip and slide method. The purpose of this article is to discuss the Slip and Slide Method and present a theoretical justification of why it works.

  19. Surface bound or cytoplasmic immunoglobulins: interpretation of the immunofluorescence observed in cytocentrifuge slides of human lymphocytes.

    PubMed Central

    Schuit, H R; Hijmans, W; Jansen, J

    1984-01-01

    Results of immunofluorescence observations in the study of normal and malignant blood lymphocytes are described. Data which support the proposition that most membrane bound immunoglobulin molecules are stable enough to remain intact during cytocentrifuge slide preparation are presented. Therefore not all positive cells in a fixed cytocentrifuge slide should be considered as containing cytoplasmic immunoglobulins. A correct interpretation is essential because of its bearing on our concepts of B lymphocyte differentiation. Images Fig. 3 PMID:6378456

  20. Robust Second Order Sliding mode Observer for the Estimation of the Vehicle States

    NASA Astrophysics Data System (ADS)

    Chaibet, A.; Nouveliere, L.; Hima, S.; Mammar, S.

    2008-06-01

    This paper is dedicated to the observation of non measurable variables for automotive systems. A non linear observer, based on a sliding mode approach, is presented for the estimation of the dynamic states of the vehicle. The considered technique is applied to the estimation problem for an automated vehicle following. Both the simulation and the experimental results are addressed to demonstrate the effectiveness of the sliding mode observer for different maneuvers, in terms of performances and robustness.

  1. FDA approval of comparative claims for prescription drugs--the Moxam case.

    PubMed

    Marcus, D

    1983-01-01

    FDA allowance of comparative claims as part of the approved labeling for new prescription drugs creates special problems. Claims contained in prescription drug labeling are viewed by physicians as embodying not just the normal puffery of the manufacturer, but the considered views of government agency charged with protecting public health. Thus, labeling claims for prescription drugs have an impact and significance that promotional claims for other products do not. In the Moxam case--a dispute between Upjohn and Lilly over the FDA's approval of a comparative claim for a new Lilly antibiotic--the agency recognized this fundamental reality. Faced with the prospect of having to provide a procedure to permit competitors to challenge approval of comparative claims, the FDA has moved toward a policy of not permitting such claims in labeling, while allowing them in advertising.

  2. Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights.

    PubMed

    Rose, Brenda

    2016-06-01

    As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 4 revised boxed warning from January through March 2016.

  3. Medical devices; medical device distributor reporting; opportunity for comments--FDA. Final rule; opportunity for comments.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing an opportunity for public comments on the final rule on medical device distributor reporting, which is published elsewhere in this issue of the Federal Register. The medical device distributor reporting tentative final rule became final on May 28, 1992, by operation of the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments). Although not required to do so, FDA realizes that there may be issues not previously considered, such as technical issues on specific provisions, and therefore is providing this additional time for comment. If changes are warranted by comments, FDA will make further changes in the rules.

  4. The FDA's role in medical device clinical studies of human subjects

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  5. The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician.

    PubMed

    Almond, Christopher S

    2012-05-01

    Pediatric medical devices play a vital role in the treatment of children with cardiovascular disease. Most cardiac medical devices used in children today are used off-label where the risk-benefit of devices has not been well characterized. Pediatric medical devices face a variety of challenges to FDA approval related in large part to the small target population, heterogeneity of the patient population and ethical considerations of device testing in children. While relatively few cardiac devices have received FDA approval in children, the number of devices navigating the approval process successfully is growing. Most pediatric device approvals are being granted through the humanitarian device exemption (HDE) pathway, which is designed for rare diseases making it suitable for devices treating congenital heart disease. This review summarizes the FDA review process for pediatric medical devices as it continues to evolve in response to the unique challenges of understanding device performance in the pediatric population. PMID:22661882

  6. Under the law, FDA must grant different standards for new dietary ingredients and food additives.

    PubMed

    Mister, Steven; Hathcock, John

    2012-04-01

    The FDA's draft Guidance on notifications for new dietary ingredients attempts to narrow the scope of "old" dietary ingredients that do not require notification to FDA and repeats some mistakes from the past by going beyond what is required or permitted by the Food, Drug & Cosmetic Act, as amended by the Dietary Supplements Health and Education Act of 1994. The draft Guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of "chemically altered" to include many changes that were not foreseen in the Congressional Record in 1994. Through these misinterpretations, FDA attempts to impose a food additives-like safety standard, and gain de facto premarket approval against the overt wishes of Congress.

  7. Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights.

    PubMed

    Rose, Brenda

    2016-06-01

    As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 4 revised boxed warning from January through March 2016. PMID:27354752

  8. Prescribing of FDA-approved and compounded hormone therapy differs by specialty

    PubMed Central

    Constantine, Ginger D.; Archer, David F.; Graham, Shelli; Bernick, Brian A.; Mirkin, Sebastian

    2016-01-01

    Abstract Objective: To determine the prescribing patterns of general practitioners (GPs), obstetrician/gynecologists (OB/GYNs), and wellness physicians (WPs) of menopausal hormone therapy (HT) for both compounded (CHT) and Food and Drug Administration (FDA)-approved products, using a survey of US physicians. Methods: Nine thousand one US physicians were invited to participate in a survey to report on their HT-prescribing patterns. Physicians were eligible if they prescribed HT for at least six patients per month. Results: The survey was completed by 440 eligible physicians (893 responded of 9,001 invited) including 171 GPs, 170 OB/GYNs, and 84 WPs. Physicians prescribed HT for 15% to 30% of their female patients, with WPs numerically most likely to prescribe HT. Menopausal symptoms were the leading reason for HT prescriptions among all specialties. WPs seemed more likely to prescribe HT for general/cardiovascular health (28%), and for shorter durations, than other specialties. WPs prescribed proportionally more compounded (vs FDA-approved) estrogens/progestogens than GPs or OB/GYNs, but OB/GYNs seemed to prescribe more compounded dehydroepiandrosterone and testosterone (prescribed alone) than did others. OB/GYNs seemed least likely to consider CHT being more safe or effective than FDA-approved HT. Symptom relief was the main determinant of efficacy for all specialties; WPs also used blood (61%) or saliva testing (25%) for dose adjustment. Conclusions: Although all physician specialties surveyed prescribed HT, differences in prescribing CHT versus FDA-approved formulations by medical specialty/practice seemed to exist. Of those surveyed, OB/GYNs and GPs prescribed proportionally more FDA-approved HT, whereas WPs, similarly, prescribed more CHT. More discussion is needed concerning physicians’ decisions to prescribe CHT versus FDA-approved formulations. PMID:27648594

  9. Real-time misfire detection via sliding mode observer

    NASA Astrophysics Data System (ADS)

    Wang, Yunsong; Chu, Fulei

    2005-07-01

    A new method to detect misfire in internal combustion engines is presented. It is based on the estimation of the cylinder deviation torque by using sliding mode observer. The input estimation problem is transformed into the control tracking problem. The sliding controller is utilised to continuously track the measured varying crank speed by changing the estimated deviation torque. During the process of tracking, the speed estimation errors decrease and the gradual stability of the dynamics is assured. The mean deviation torque during the power stroke derived from the estimated deviation torque can be employed to detect easily engine misfires. Experimental results for a four-cylinder engine indicate that the method is a suitable tool for real-time misfire detection on board vehicle under various working conditions.

  10. Evidence of Self-Organized Criticality in Dry Sliding Friction

    NASA Technical Reports Server (NTRS)

    Zypman, Fredy R.; Ferrante, John; Jansen, Mark; Scanlon, Kathleen; Abel, Phillip

    2003-01-01

    This letter presents experimental results on unlubricated friction, which suggests that stick-slip is described by self-organized criticality (SOC). The data, obtained with a pin-on-disc tribometer examines the variation of the friction force as a function of time-or sliding distance. This is the first time that standard tribological equipment has been used to examine the possibility of SOC. The materials were matching pins and discs of aluminium loaded with 250, 500 and 1000 g masses, and matching M50 steel couples loaded with a 1000 g mass. An analysis of the data shows that the probability distribution of slip sizes follows a power law. We perform a careful analysis of all the properties, beyond the two just mentioned, which are required to imply the presence of SOC. Our data strongly support the existence of SOC for stick-slip in dry sliding friction.

  11. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal.

    PubMed

    1998-08-27

    The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

  12. Sliding bubble dynamics and the effects on surface heat transfer

    NASA Astrophysics Data System (ADS)

    Donnelly, B.; Robinson, A. J.; Delauré, Y. M. C.; Murray, D. B.

    2012-11-01

    An investigation into the effects of a single sliding air bubble on heat transfer from a submerged, inclined surface has been undertaken. Existing literature has shown that both vapour and gas bubbles can increase heat transfer rates from adjacent heated surfaces. However, the mechanisms involved are complex and dynamic and in some cases poorly understood. The present study utilises high speed, high resolution, infrared thermography and video photography to measure two dimensional surface heat transfer and three dimensional bubble position and shape. This provides a unique insight into the complex interactions at the heated surface. Bubbles of volume 0.05, 0.1, 0.2 and 0.4 ml were released onto a surface inclined at 30 degrees to horizontal. Results confirmed that sliding bubbles can enhance heat transfer rates up to a factor of 9 and further insight was gained about the mechanisms behind this phenomenon. The enhancement effects were observed over large areas and persisted for a long duration with the bubble exhibiting complex shape and path oscillations. It is believed that the periodic wake structure present behind the sliding bubble affects the bubble motion and is responsible for the heat transfer effects observed. The nature of this wake is proposed to be that of a chain of horseshoe vortices.

  13. A sliding cell technique for diffusion measurements in liquid metals

    SciTech Connect

    Geng, Yongliang; Zhu, Chunao; Zhang, Bo

    2014-03-15

    The long capillary and shear cell techniques are the usual methods for diffusion measurements in liquid metals. Here we present a new “sliding cell technique” to measure interdiffusion in liquid alloys, which combines the merits of these two methods. Instead of a number of shear cells, as used in the shear cell method, only one sliding cell is designed to separate and join the liquid diffusion samples. Using the sliding cell technique, the influence of the heating process (which affects liquid diffusion measurements in the conventional long capillary method) can be eliminated. Time-dependent diffusion measurements at the same isothermal temperature were carried out in Al-Cu liquids. Compared with the previous results measured by in-situ X-ray radiography, the obtained liquid diffusion coefficient in this work is believed to be influenced by convective flow. The present work further supports the idea that to obtain accurate diffusion constants in liquid metals, the measurement conditions must be well controlled, and there should be no temperature gradients or other disturbances.

  14. FDA publishes checklist of Y2K high-risk devices.

    PubMed

    1999-09-01

    Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.

  15. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    Cancer.gov

    The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

  16. Imaging as a tumor biomarker in oncology drug trials for lung cancer: the FDA perspective.

    PubMed

    Petrick, N; Brown, D G; Suleiman, O; Myers, K J

    2008-10-01

    The US Food and Drug Administration (FDA) is committed to working with the oncology community to expedite the drug evaluation process in view of the many promising new oncology drugs under laboratory development and the time and expense required for such new drugs to reach the patient population. One significant advance would be to enable quantitative imaging as a tumor biomarker. The FDA is working with the pharmaceutical industry, academia, and sister stakeholders in the government, primarily through collaborative educational and research efforts, to identify how imaging can serve this function. PMID:18716616

  17. Sliding Wear Response of Beryl Reinforced Aluminum Composite - A Factorial Design Approach

    NASA Astrophysics Data System (ADS)

    Bharat, V.; Durga Prasad, B.; Prabhakar, M. Bhovi; Venkateswarlu, K.

    2016-02-01

    Al-Beryl MMCs were successfully fabricated using powder metallurgy route. Processing conditions such as beryl content and particle size were varied and its influence on dry sliding wear response was studied. Effect of test parameters like applied load and sliding distance on wear performance of Al-Beryl MMCs were discussed detail. Sliding wear tests were conducted using a pin on disc machine based on the 24 (4 factors at 2 levels) factorial design. Analysis of variance (ANOVA) was performed to obtain the contribution of control parameters on wear rate. The present study shows that wear resistance of Al-beryl MMCs not only depends on the beryl content but also influenced by normal load, sliding distance and particle size. The results show that most significant variables affecting wear rate of Al - beryl MMCs are size of the beryl particles (22%), beryl content (19.60%), sliding distance (18.47%), and normal load (10.30%). The interaction effects of these parameters are less significant in influencing wear rate compared to the individual parameters. The correlation between sliding wear and its parameters was obtained by multiple regression analysis. Regression model developed in the present study can be successfully implemented to predict the wear response of Al-Beryl MMCs.

  18. Musical slide show MAF with protection and governance using MPEG-21 IPMP Components and REL

    NASA Astrophysics Data System (ADS)

    Sabirin, Muhammad Syah Houari; Tan, Hendry; Lim, Jeongyeon; Kim, Munchurl

    2007-02-01

    The Musical Slide Show Multimedia Application Format (MAF) which is currently being standardized by the Moving Picture Expert Group (MPEG) conveys the concept of combining several established standard technologies in a single file format. It defines the format of packing up MP3 audio data, along with JPEG images, MPEG-7 Simple Profile metadata, timed text, and MPEG-4 LASeR script. The presentation of Musical Slide Show MAF contents is made in a synchronized manner with JPEG images, timed text to MP3 audio track. Also, the rendering effect on JPEG images can be supported by the MPEG-4 LASeR script. This Musical Slide Show MAF will enrich the consumption of MP3 contents assisted with synchronized and rendered JPEG images, text as well as MPEG-7 metadata about the MP3 audio contents. However, there is no protection and governance mechanism for Musical Slide Show MAF which is the essential elements to deploy the sorts of contents. In this paper, to manage the Musical Slide Show MAF contents in a controlled manner, we present a protection and governance mechanism by using MPEG-21 Intellectual Property Management and Protection (IPMP) Components and MPEG-21 Rights Expression Language (REL) technologies We implement an authoring tool and a player tool for Musical Slide Show MAF contents and show the experimental results as well.

  19. Registration of sliding objects using direction dependent B-splines decomposition

    NASA Astrophysics Data System (ADS)

    Delmon, V.; Rit, S.; Pinho, R.; Sarrut, D.

    2013-03-01

    Sliding motion is a challenge for deformable image registration because it leads to discontinuities in the sought deformation. In this paper, we present a method to handle sliding motion using multiple B-spline transforms. The proposed method decomposes the sought deformation into sliding regions to allow discontinuities at their interfaces, but prevents unrealistic solutions by forcing those interfaces to match. The method was evaluated on 16 lung cancer patients against a single B-spline transform approach and a multi B-spline transforms approach without the sliding constraint at the interface. The target registration error (TRE) was significantly lower with the proposed method (TRE = 1.5 mm) than with the single B-spline approach (TRE = 3.7 mm) and was comparable to the multi B-spline approach without the sliding constraint (TRE = 1.4 mm). The proposed method was also more accurate along region interfaces, with 37% less gaps and overlaps when compared to the multi B-spline transforms without the sliding constraint. This work was presented in part at the 4th International Workshop on Pulmonary Image Analysis during the Medical Image Computing and Computer Assisted Intervention (MICCAI) in Toronto, Canada (2011).

  20. Terminal sliding mode tracking control for a class of SISO uncertain nonlinear systems.

    PubMed

    Chen, Mou; Wu, Qing-Xian; Cui, Rong-Xin

    2013-03-01

    In this paper, the terminal sliding mode tracking control is proposed for the uncertain single-input and single-output (SISO) nonlinear system with unknown external disturbance. For the unmeasured disturbance of nonlinear systems, terminal sliding mode disturbance observer is presented. The developed disturbance observer can guarantee the disturbance approximation error to converge to zero in the finite time. Based on the output of designed disturbance observer, the terminal sliding mode tracking control is presented for uncertain SISO nonlinear systems. Subsequently, terminal sliding mode tracking control is developed using disturbance observer technique for the uncertain SISO nonlinear system with control singularity and unknown non-symmetric input saturation. The effects of the control singularity and unknown input saturation are combined with the external disturbance which is approximated using the disturbance observer. Under the proposed terminal sliding mode tracking control techniques, the finite time convergence of all closed-loop signals are guaranteed via Lyapunov analysis. Numerical simulation results are given to illustrate the effectiveness of the proposed terminal sliding mode tracking control.

  1. Improving Student Group Marketing Presentations: A Modified Pecha Kucha Approach

    ERIC Educational Resources Information Center

    Oliver, Jason; Kowalczyk, Christine

    2013-01-01

    Student presentations can often seem like a formality rather than a lesson in representing oneself or group in a professional manner. To improve the quality of group presentations, the authors modified the popular presentation style of Pecha Kucha (20 slides, 20 seconds per slide) for marketing courses to help students prepare and deliver…

  2. Analysis of slide exploration strategy of cytologists when reading digital slides

    NASA Astrophysics Data System (ADS)

    Pantanowitz, Liron; Parwani, Anil; Tseytlin, Eugene; Mello-Thoms, Claudia

    2012-02-01

    Cytology is the sub-domain of Pathology that deals mainly with the diagnosis of cellular changes caused by disease. Current clinical practice involves a cytotechnologist that manually screens glass slides containing fixed cytology material using a light microscope. Screened slides are then forwarded to a specialized pathologist, a cytopathologist, for microscopic review and final diagnostic interpretation. If no abnormalities are detected, the specimen is interpreted as "normal", otherwise the abnormalities are marked with a pen on the glass slide by the cytotechnologist and then are used to render a diagnosis. As Pathology is migrating towards a digital environment it is important to determine whether these crucial screening and diagnostic tasks can be performed as well using digital slides as the current practice with glass slides. The purpose of this work is to make this assessment, by using a set of digital slides depicting cytological materials of different disease processes in several organs, and then to analyze how different cytologists including cytotechnologists, cytopathologists and cytotechnology-trainees explored the digital slides. We will (1) collect visual search data from the cytologists as they navigate the digital slides, as well as record any electronic marks (annotations) made by the cytologists; (2) convert the dynamic visual search data into a static representation of the observers' exploration strategy using 'search maps'; and (3) determine slide coverage, per viewing magnification range, for each group. We have developed a virtual microscope to collect this data, and this interface allows for interactive navigation of the virtual slide (including panning and zooming), as well as annotation of reportable findings. Furthermore, all interactions with the interface are time stamped, which allows us to recreate the cytologists' search strategy.

  3. Stain Specific Standardization of Whole-Slide Histopathological Images.

    PubMed

    Bejnordi, Babak Ehteshami; Litjens, Geert; Timofeeva, Nadya; Otte-Höller, Irene; Homeyer, André; Karssemeijer, Nico; van der Laak, Jeroen A W M

    2016-02-01

    Variations in the color and intensity of hematoxylin and eosin (H&E) stained histological slides can potentially hamper the effectiveness of quantitative image analysis. This paper presents a fully automated algorithm for standardization of whole-slide histopathological images to reduce the effect of these variations. The proposed algorithm, called whole-slide image color standardizer (WSICS), utilizes color and spatial information to classify the image pixels into different stain components. The chromatic and density distributions for each of the stain components in the hue-saturation-density color model are aligned to match the corresponding distributions from a template whole-slide image (WSI). The performance of the WSICS algorithm was evaluated on two datasets. The first originated from 125 H&E stained WSIs of lymph nodes, sampled from 3 patients, and stained in 5 different laboratories on different days of the week. The second comprised 30 H&E stained WSIs of rat liver sections. The result of qualitative and quantitative evaluations using the first dataset demonstrate that the WSICS algorithm outperforms competing methods in terms of achieving color constancy. The WSICS algorithm consistently yields the smallest standard deviation and coefficient of variation of the normalized median intensity measure. Using the second dataset, we evaluated the impact of our algorithm on the performance of an already published necrosis quantification system. The performance of this system was significantly improved by utilizing the WSICS algorithm. The results of the empirical evaluations collectively demonstrate the potential contribution of the proposed standardization algorithm to improved diagnostic accuracy and consistency in computer-aided diagnosis for histopathology data.

  4. The Relation Between Grain-Boundary Structure and Sliding Resistance

    SciTech Connect

    Hoagland, Richard G.; Kurtz, Richard J.

    2002-04-01

    During sliding, the grain boundary (GB) energy depends on the atomic structures produced during relative translation of the two grains. The variation of the GB energy within the two-dimensional boundary unit cell (BUC) constitutes the GB gamma surface. Maxima in the slope of the gamma surface determines the sliding resistance, i.e., the stress required to move the system over the lowest saddle points along a particular path within the BUC. In this paper we present the results of an atomistic study of the gamma surfaces for two types of boundaries in an fcc metal, a, Sigma 11<110>{131} is a low energy boundary and has a simple gamma surface with a single stable configuration located at the corners and center of the BUC. The resistance to sliding was determined by chain-of-states methods along four shear vectors connecting equivalent states within the BUC and is found to be very high in all cases. The asymmetric GB has a higher GB energy and its gamma surface is much more complex, with distinctly different structures appearing at various locations in the BUC. At certain locations more than one structure is found for the asymmetric GB. Although complex, a chain-of-states calculation along one path across the BUC suggests that the shear strength of this GB is also quite high. Extrinsic GB dislocations are found to lower the resistance to shear considerably, and, therefore, perform the same role in shear of GBs as do glide dislocations in slip of the lattice. The existence of multiple configurations has significant implications for the interaction of lattice dislocations with GBs, the core structure of GB dislocations, the temperature dependence of GB properties, and the GB sliding resistance, which we discuss.

  5. On a model of frictional sliding

    NASA Astrophysics Data System (ADS)

    Estrin, Y.; Bréchet, Y.

    1996-10-01

    A model of frictional sliding with an N-shaped curve for the sliding velocity dependence of the coefficient of friction is considered. This type of friction law is shown to be related to dynamic i.e., velocity dependent ‘ageing’ of asperity junctions. Mechanisms of ‘ageing’ for ductile (Bowden-Tabor) and brittle (Byerlee) materials, though different in nature, lead to qualitatively similar N-shaped velocity dependencies of the coefficient of friction. Estimates for the velocities limiting the range of negative velocity sensitivity of the coefficient of friction are obtained for the ductile case and—albeit with a lesser degree of reliability—for the brittle one. It is shown by linear stability analysis that discontinuous sliding (stick-slip) is associated with the descending portion of the N-shaped curve. An instability criterion is obtained. An expression for the period of the attendant relaxation oscillations of the sliding velocity is given in terms of the calculated velocity dependence of the coefficient of friction. It is suggested that the micromechanically motivated friction law proposed should be used in models of earthquakes due to discontinuous frictional sliding on a crustal fault.

  6. Resistance to Sliding on Atomic Scales

    NASA Technical Reports Server (NTRS)

    Dominik, C.; Tielens, A.; Cuzzi, Jeffrey (Technical Monitor)

    1995-01-01

    The structure and stability of agglomerates of micron-sized particles is determined by the mechanical properties of the individual contacts between the constituent particles. In this paper we study the possibility of aggregate rearrangements by sliding. Since the contacts between (sub)micron particles are only a few hundred atoms in diameter, processes on atomic levels will play the dominating roll. We study a theoretical model of sliding friction for surfaces that are either flat or contain steps in their grids. The results show that sliding over flat surfaces may produce a large range of friction coefficients, including zero if the adhesive forces are small compared to the binding forces inside a body. However, both grid alignment and steps in the surface will lead to high values for friction. These processes combined virtually eliminate the possibility of sliding in a collision of two (sub)micron sized particles at velocities low enough for sticking to occur. On the other hand we show that in collisions between aggregates sliding may be an important factor for energy dissipation and compaction.

  7. Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning

    ERIC Educational Resources Information Center

    Taylor, Christy Marie

    2013-01-01

    In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…

  8. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Affecting the Hematopoietic System.'' That draft guidance, when finalized, is intended to supersede the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  9. Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

    PubMed

    Bradford, W David; Kleit, Andrew N

    2015-07-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. PMID:25059655

  10. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of the... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on...

  11. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false FDA recognition of exclusive marketing rights. 516.34 Section 516.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... for maintaining MUMS-designated drug exclusive marketing rights for the full 7-year term. This...

  12. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  13. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  14. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  15. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  16. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  17. 21 CFR 1271.3 - How does FDA define important terms in this part?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... CFR 121.2, that are intended for use in organ transplantation and labeled “For use in organ... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS General Provisions § 1271.3 How does FDA... use means the implantation, transplantation, infusion, or transfer of human cells or tissue back...

  18. 21 CFR 1271.3 - How does FDA define important terms in this part?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... CFR 121.2, that are intended for use in organ transplantation and labeled “For use in organ... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS General Provisions § 1271.3 How does FDA... use means the implantation, transplantation, infusion, or transfer of human cells or tissue back...

  19. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  20. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements... dosage directions. 10. A graphic appears at the bottom of the first panel leading the reader to the...

  1. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements... dosage directions. 10. A graphic appears at the bottom of the first panel leading the reader to the...

  2. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA define the terms used in this part? Some of the terms we use in this part are specific to medical device... services or any other facility) or operated by another medical entity (e.g., under the common...

  3. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced...

  4. Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems.

    PubMed

    Sapsford, Kim E; Lauritsen, Kristina; Tyner, Katherine M

    2012-12-01

    The US FDA is the US agency responsible for regulating intelligent drug-delivery systems (IDDS). IDDS can be classified as a device, drug, biologic or combination product. In this perspective, the current regulatory framework for IDDS and future perspectives on how the field is expected to evolve from a regulatory standpoint is discussed.

  5. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA... reporting and reflect the language used in the statute (law). Other terms are more general and reflect our... recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF...

  6. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Will FDA assign me a registration number? 1271.27 Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN...

  7. Formation of a 6FDA-based ring polyimide with nanoscale cavity evaluated by DFT calculations

    NASA Astrophysics Data System (ADS)

    Fukuda, Mitsuhiro; Takao, Yoshimi; Tamai, Yoshinori

    2005-04-01

    The computer-aided molecular design of a rigid ring molecule has been performed. As a candidate molecule, the polyimide derived from 2,2-bis(3,4-carboxylphenyl) hexafluoropropane dianhydride (6FDA) with m-phenylenediamine (MDA) has been used. The optimized structures of the 6FDA-MDA model compounds including a precursor type amic acid model were investigated using the density functional theory (DFT) at the B3LYP/6-311G(d,p) level. Using the optimized structures of the model compounds, the probable combinations to form a flat ring polyimide are considered by taking the spatial angles between the respective aromatic groups into consideration. We selected several combinations with different conformations and the number of monomer units. We showed that the dimer, trimer and tetramer of not only the 6FDA-based ring imide but also the corresponding ring amic acid can have a stable geometry. Each of them contains a cavity of sub-nanometer size and characteristic shape. Among them, the interaction energy with some guest molecules are evaluated for the smallest ring imide constructed from two units of 6FDA-MDA using the DFT calculations.

  8. Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.

    PubMed

    Bobo, Daniel; Robinson, Kye J; Islam, Jiaul; Thurecht, Kristofer J; Corrie, Simon R

    2016-10-01

    In this review we provide an up to date snapshot of nanomedicines either currently approved by the US FDA, or in the FDA clinical trials process. We define nanomedicines as therapeutic or imaging agents which comprise a nanoparticle in order to control the biodistribution, enhance the efficacy, or otherwise reduce toxicity of a drug or biologic. We identified 51 FDA-approved nanomedicines that met this definition and 77 products in clinical trials, with ~40% of trials listed in clinicaltrials.gov started in 2014 or 2015. While FDA approved materials are heavily weighted to polymeric, liposomal, and nanocrystal formulations, there is a trend towards the development of more complex materials comprising micelles, protein-based NPs, and also the emergence of a variety of inorganic and metallic particles in clinical trials. We then provide an overview of the different material categories represented in our search, highlighting nanomedicines that have either been recently approved, or are already in clinical trials. We conclude with some comments on future perspectives for nanomedicines, which we expect to include more actively-targeted materials, multi-functional materials ("theranostics") and more complicated materials that blur the boundaries of traditional material categories. A key challenge for researchers, industry, and regulators is how to classify new materials and what additional testing (e.g. safety and toxicity) is required before products become available. PMID:27299311

  9. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

  10. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

  11. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

  12. NCL Partnerships - U.S. Food and Drug Administration (FDA)- Nanotechnology Characterization Laboratory

    Cancer.gov

    The activities within the NCL represent a formal scientific interaction of three Federal agencies: National Cancer Institute and U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services, and National Institute of Standards and Technology (NIST) of the Department of Commerce.

  13. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention order? 1.393 Section 1.393 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...

  14. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  15. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  16. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  17. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  18. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  19. DMSO, Hobby Shops and the FDA: The Diffusion of a Health Policy Dilemma.

    ERIC Educational Resources Information Center

    Weinstock, Edward; Davis, Phillip

    1985-01-01

    Despite being banned by the FDA, DMSO (dimethyl sulfoxide) usage has spread rapidly among arthritic victims and weekend athletes. This study looked at current and past users to learn how they discovered DMSO, their reactions to buying an illegal drug, and possible implications for public health policy. (MT)

  20. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Will FDA assign me a registration number? 1271.27... (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will...

  1. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Will FDA assign me a registration number? 1271.27... (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will...

  2. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Will FDA assign me a registration number? 1271.27... (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will...

  3. Quantitative analysis on the characteristics of targets with FDA approved drugs

    PubMed Central

    Sakharkar, Meena K.; Li, Peng; Zhong, Zhaowei; Sakharkar, Kishore R.

    2008-01-01

    Accumulated knowledge of genomic information, systems biology, and disease mechanisms provide an unprecedented opportunity to elucidate the genetic basis of diseases, and to discover new and novel therapeutic targets from the wealth of genomic data. With hundreds to a few thousand potential targets available in the human genome alone, target selection and validation has become a critical component of drug discovery process. The explorations on quantitative characteristics of the currently explored targets (those without any marketed drug) and successful targets (targeted by at least one marketed drug) could help discern simple rules for selecting a putative successful target. Here we use integrative in silico (computational) approaches to quantitatively analyze the characteristics of 133 targets with FDA approved drugs and 3120 human disease genes (therapeutic targets) not targeted by FDA approved drugs. This is the first attempt to comparatively analyze targets with FDA approved drugs and targets with no FDA approved drug or no drugs available for them. Our results show that proteins with 5 or fewer number of homologs outside their own family, proteins with single-exon gene architecture and proteins interacting with more than 3 partners are more likely to be targetable. These quantitative characteristics could serve as criteria to search for promising targetable disease genes. PMID:18167532

  4. ADVERSE PRE- AND POSTNATAL EVENTS REPORTED TO FDA IN ASSOCIATION WITH MATERNAL ATENOLOL TREATMENT IN PREGNANCY

    EPA Science Inventory

    Atenolol is a beta-adrenoreceptor blocker used for treatment of hypertension in pregnancy. This study evaluates the reporting frequency of adverse pre- and postnatal outcomes in a series of 70 cases of maternal exposure during gestation, derived from 140 reports to FDA with Ateno...

  5. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... HUMAN SERVICES Food and Drug Administration FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. SUMMARY: As...

  6. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...; (7) The address and location where the article of food is to be detained and the appropriate storage... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention order? 1.393 Section 1.393 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  7. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...; (7) The address and location where the article of food is to be detained and the appropriate storage... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What information must FDA include in the detention order? 1.393 Section 1.393 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  8. Presenting Mitosis

    ERIC Educational Resources Information Center

    Roche, Stephanie; Sterling, Donna R.

    2005-01-01

    When the topic of cell division is introduced in the classroom, students can showcase their interpretations of the stages of mitosis by creating a slide show illustrating prophase, metaphase, anaphase, and telophase (see samples in Figure 1). With the help of a computer, they can create a model of mitosis that will help them distinguish the…

  9. Education techniques for lifelong learning: making a PowerPoint presentation.

    PubMed

    Collins, Jannette

    2004-01-01

    Most radiologists are now creating their own image and text slides for oral presentations. PowerPoint software offers a tremendous number of options for personalizing slides. Having choices of font, color scheme, display options, sound, and graphics provide an opportunity to enhance a presentation in ways that were not possible with 35-mm slides and slide projectors. However, inappropriate use of PowerPoint features can substantially degrade the quality of a presentation. Many of the "rules" for creating an effective presentation given with slide projectors apply to electronic presentations, but some of the options available with only electronic presentations (eg, building, transitioning, and sound) necessitate new "rules." The article provides tips on how to develop effective text and image slides for electronic presentation by using PowerPoint, including the appropriate use of text, font, color, sound, graphics, slide display, and radiologic images.

  10. Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library

    PubMed Central

    Feng, Jie; Weitner, Megan; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Zhang, Ying

    2015-01-01

    Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2–4 week antibiotic treatment, 10%–20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS). While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics) used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV), thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin), and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy production, and

  11. Identification of novel activity against Borrelia burgdorferi persisters using an FDA approved drug library

    PubMed Central

    Feng, Jie; Wang, Ting; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Auwaerter, Paul G; Zhang, Ying

    2014-01-01

    Although antibiotic treatment for Lyme disease is effective in the majority of cases, especially during the early phase of the disease, a minority of patients suffer from post-treatment Lyme disease syndrome (PTLDS). It is unclear what mechanisms drive this problem, and although slow or ineffective killing of Borrelia burgdorferi has been suggested as an explanation, there is a lack of evidence that viable organisms are present in PTLDS. Although not a clinical surrogate, insight may be gained by examining stationary-phase in vitro Borrelia burgdorferi persisters that survive treatment with the antibiotics doxycycline and amoxicillin. To identify drug candidates that can eliminate B. burgdorferi persisters more effectively, we screened an Food and Drug Administration (FDA)-approved drug library consisting of 1524 compounds against stationary-phase B. burgdorferi by using a newly developed high throughput SYBR Green I/propidium iodide (PI) assay. We identified 165 agents approved for use in other disease conditions that had more activity than doxycycline and amoxicillin against B. burgdorferi persisters. The top 27 drug candidates from the 165 hits were confirmed to have higher anti-persister activity than the current frontline antibiotics. Among the top 27 confirmed drug candidates from the 165 hits, daptomycin, clofazimine, carbomycin, sulfa drugs (e.g., sulfamethoxazole), and certain cephalosporins (e.g. cefoperazone) had the highest anti-persister activity. In addition, some drug candidates, such as daptomycin and clofazimine (which had the highest activity against non-growing persisters), had relatively poor activity or a high minimal inhibitory concentration (MIC) against growing B. burgdorferi. Our findings may have implications for the development of a more effective treatment for Lyme disease and for the relief of long-term symptoms that afflict some Lyme disease patients. PMID:26038747

  12. Identification of novel activity against Borrelia burgdorferi persisters using an FDA approved drug library.

    PubMed

    Feng, Jie; Wang, Ting; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Auwaerter, Paul G; Zhang, Ying

    2014-07-01

    Although antibiotic treatment for Lyme disease is effective in the majority of cases, especially during the early phase of the disease, a minority of patients suffer from post-treatment Lyme disease syndrome (PTLDS). It is unclear what mechanisms drive this problem, and although slow or ineffective killing of Borrelia burgdorferi has been suggested as an explanation, there is a lack of evidence that viable organisms are present in PTLDS. Although not a clinical surrogate, insight may be gained by examining stationary-phase in vitro Borrelia burgdorferi persisters that survive treatment with the antibiotics doxycycline and amoxicillin. To identify drug candidates that can eliminate B. burgdorferi persisters more effectively, we screened an Food and Drug Administration (FDA)-approved drug library consisting of 1524 compounds against stationary-phase B. burgdorferi by using a newly developed high throughput SYBR Green I/propidium iodide (PI) assay. We identified 165 agents approved for use in other disease conditions that had more activity than doxycycline and amoxicillin against B. burgdorferi persisters. The top 27 drug candidates from the 165 hits were confirmed to have higher anti-persister activity than the current frontline antibiotics. Among the top 27 confirmed drug candidates from the 165 hits, daptomycin, clofazimine, carbomycin, sulfa drugs (e.g., sulfamethoxazole), and certain cephalosporins (e.g. cefoperazone) had the highest anti-persister activity. In addition, some drug candidates, such as daptomycin and clofazimine (which had the highest activity against non-growing persisters), had relatively poor activity or a high minimal inhibitory concentration (MIC) against growing B. burgdorferi. Our findings may have implications for the development of a more effective treatment for Lyme disease and for the relief of long-term symptoms that afflict some Lyme disease patients.

  13. Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers

    PubMed Central

    Butterfield, Lisa H.; Palucka, A. Karolina; Britten, Cedrik M.; Dhodapkar, Madhav V.; Håkansson, Leif; Janetzki, Sylvia; Kawakami, Yutaka; Kleen, Thomas-Oliver; Lee, Peter P.; Maccalli, Cristina; Maecker, Holden T.; Maino, Vernon C.; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Pawelec, Graham; Potter, Douglas M.; Rivoltini, Licia; Salazar, Lupe G.; Schendel, Dolores J.; Slingluff, Craig L.; Song, Wenru; Stroncek, David F.; Tahara, Hideaki; Thurin, Magdalena; Trinchieri, Giorgio; van Der Burg, Sjoerd H.; Whiteside, Theresa L.; Wigginton, Jon M.; Marincola, Francesco; Khleif, Samir; Fox, Bernard A.; Disis, Mary L.

    2011-01-01

    Purpose To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of anti-tumor immunity to measure and which assays are optimal for those measurements. Experimental Design The iSBTc-SITC, FDA and NCI partnered to address these issues for immunotherapy of cancer. Here, we review the major challenges, give examples of approaches and solutions and present our recommendations. Results and Conclusions While specific immune parameters and assays are not yet validated, we recommend following standardized (accurate, precise and reproducible) protocols and use of functional assays for the primary immunologic readouts of a trial; consideration of central laboratories for immune monitoring of large, multi-institutional trials; and standardized testing of several phenotypic and functional potential potency assays specific to any cellular product. When reporting results, the full QA/QC performed, selected examples of truly representative raw data and assay performance characteristics should be included. Lastly, to promote broader analysis of multiple aspects of immunity, and gather data on variability, we recommend that in addition to cells and serum, that RNA and DNA samples be banked (under standardized conditions) for later testing. We also recommend that sufficient blood be drawn to allow for planned testing of the primary hypothesis being addressed in the trial, and that additional baseline and post-treatment blood is banked for testing novel hypotheses (or generating new hypotheses) that arise in the field. PMID:21558394

  14. Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library.

    PubMed

    Feng, Jie; Weitner, Megan; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Zhang, Ying

    2015-01-01

    Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2-4 week antibiotic treatment, 10%-20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS). While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics) used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV), thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin), and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy production, and reactive

  15. DOE/FDA/EPA: Workshop on methylmercury and human health

    SciTech Connect

    Moskowitz, P.D.; Saroff, L.; Bolger, M.; Cicmanec, J.; Durkee, S.

    1994-12-31

    In the US the general population is exposed to methylmercury (MeHg) principally through the consumption of fish. There is continuing discussion about the sources of this form of mercury (Hg), the magnitudes and trends in exposures to consumers, and the significance of the sources and their contributions to human health. In response to these discussions, the US Department of Energy, the US Food and Drug Administration, and the US Environmental Protection Agency cosponsored a two-day workshop to discuss data and methods available for characterizing the risk to human health presented by MeHg. This workshop was attended by 45 individuals representing various Federal and state organizations and interested stakeholders. The agenda covered: Agency interests; probabilistic approach to risk assessment; emission sources; atmospheric transport; biogeochemical cycling; exposure assessment; health effects of MeHg; and research needs.

  16. Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment.

    PubMed

    Fatehi, Leili; Hall, Ralph F

    2015-01-01

    Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges. This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value ofPOA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes

  17. NEMD simulations for ductile metal sliding

    SciTech Connect

    Hammerberg, James E; Germann, Timothy C; Ravelo, Ramon J; Holian, Brad L

    2011-01-31

    We have studied the sliding behavior for a 19 M Al(110)/Al(110) defective crystal at 15 GPa as a function of relative sliding velocity. The general features are qualitatively similar to smaller scale (1.4 M) atom simulations for Al(111)/Al(110) nondefective single crystal sliding. The critical velocity, v{sub c}, is approximately the same for the defective crystal as the size scaled v{sub c}. The lower velocity tangential force is depressed relative to the perfect crystal. The critical temperature, T*, is depressed relative to the perfect crystal. These conclusions are consistent with a lower value for f{sub c} for the defective crystal. The detailed features of structural transformation and the high velocity regime remain to be mapped.

  18. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    PubMed

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. PMID:26791369

  19. From bench to FDA to bedside: US regulatory trends for new stem cell therapies.

    PubMed

    Knoepfler, Paul S

    2015-03-01

    The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as "The Valley of Death". This moniker seems appropriate because it is at this point, and in particular in the work that ensues after Phase 1, clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here.

  20. From Bench to FDA to Bedside: US Regulatory Trends for New Stem Cell Therapies

    PubMed Central

    Knoepfler, Paul S.

    2015-01-01

    The phrase “bench to bedside” is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as “The Valley of Death”. This moniker seems appropriate because it is at this point and in particular in the work that ensues after Phase 1 clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here. PMID:25489841

  1. Use of surrogate outcomes in US FDA drug approvals, 2003–2012: a survey

    PubMed Central

    Yu, Tsung; Hsu, Yea-Jen; Fain, Kevin M; Boyd, Cynthia M; Holbrook, Janet T; Puhan, Milo A

    2015-01-01

    Objective To evaluate, across a spectrum of diseases, how often surrogate outcomes are used as a basis for drug approvals by the US Food and Drug Administration (FDA), and whether and how the rationale for using treatment effects on surrogates as predictors of treatment effects on patient-centred outcomes is discussed. Study design and setting We used the Drugs@FDA website to identify drug approvals produced from 2003 to 2012 by the FDA. We focused on four diseases (chronic obstructive pulmonary disease (COPD), type 1 or 2 diabetes, glaucoma and osteoporosis) for which surrogates are commonly used in trials. We reviewed the drug labels and medical reviews to provide empirical evidence on how surrogate outcomes are handled by the FDA. Results Of 1043 approvals screened, 58 (6%) were for the four diseases of interest. Most drugs for COPD (7/9, 78%), diabetes (26/26, 100%) and glaucoma (9/9, 100%) were approved based on surrogates while for osteoporosis, most drugs (10/14, 71%) were also approved for patient-centred outcomes (fractures). The rationale for using surrogates was discussed in 11 of the 43 (26%) drug approvals based on surrogates. In these drug approvals, we found drug approvals for diabetes are more likely than the other examined conditions to contain a discussion of trial evidence demonstrating that treatment effects on surrogate outcomes predict treatment effects on patient-centred outcomes. Conclusions Our results suggest that the FDA did not use a consistent approach to address surrogates in assessing the benefits and harms of drugs for COPD, type 1 or 2 diabetes, glaucoma and osteoporosis. For evaluating new drugs, patient-centred outcomes should be chosen whenever possible. If the use of surrogate outcomes is necessary, then a consistent approach is important to review the evidence for surrogacy and consider surrogate's usage in the treatment and population under study. PMID:26614616

  2. FDA & digital mammography: why has FDA required full field digital mammography systems to be regulated as potentially dangerous devices for more than 10 years?

    PubMed

    Nields, Morgan W

    2010-05-01

    Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience

  3. Universal fuzzy integral sliding-mode controllers for stochastic nonlinear systems.

    PubMed

    Gao, Qing; Liu, Lu; Feng, Gang; Wang, Yong

    2014-12-01

    In this paper, the universal integral sliding-mode controller problem for the general stochastic nonlinear systems modeled by Itô type stochastic differential equations is investigated. One of the main contributions is that a novel dynamic integral sliding mode control (DISMC) scheme is developed for stochastic nonlinear systems based on their stochastic T-S fuzzy approximation models. The key advantage of the proposed DISMC scheme is that two very restrictive assumptions in most existing ISMC approaches to stochastic fuzzy systems have been removed. Based on the stochastic Lyapunov theory, it is shown that the closed-loop control system trajectories are kept on the integral sliding surface almost surely since the initial time, and moreover, the stochastic stability of the sliding motion can be guaranteed in terms of linear matrix inequalities. Another main contribution is that the results of universal fuzzy integral sliding-mode controllers for two classes of stochastic nonlinear systems, along with constructive procedures to obtain the universal fuzzy integral sliding-mode controllers, are provided, respectively. Simulation results from an inverted pendulum example are presented to illustrate the advantages and effectiveness of the proposed approaches.

  4. Newly recognized submarine slide complexes in the southern California Bight

    NASA Astrophysics Data System (ADS)

    Conrad, J. E.; Lee, H. J.; Edwards, B. D.; McGann, M.; Sliter, R. W.

    2012-12-01

    New high-resolution bathymetric and seismic-reflection surveys have imaged large (<0.5 km3) submarine landslides offshore southern California that have not been previously recognized in the Borderland. The new data show several large slides or slide complexes that include: 1) a slide complex consisting of numerous (>7) individual overlapping slides along the western margin of Santa Cruz Basin (SCB slide); 2) a series of slumps and slide scars on the slope south of San Pedro shelf (SPS slide); and 3) a slope failure along the shelf edge in northern San Diego County, termed the Del Mar slide. The SCB slide complex extends for 30 km along the western slope of Santa Cruz Basin, with debris lobes extending 5-8 km into the basin. Head scarps of some of these slides are 50-75 m high. The SPS slide complex also appears to consist of multiple slides, which roughly parallel the Palos Verdes Fault and the San Gabriel Canyon submarine channel on the shelf edge and slope south of San Pedro shelf. Slide deposits associated with this complex are only partially mapped due to limited high-resolution bathymetric coverage, but extend to the south in the area SW of Lasuen Knoll. Seismic-reflection profiles show that some of these deposits are up to 20 m thick. The Del Mar slide is located about 10 km north of La Jolla Canyon and extends about 6 km along the shelf edge. The head scarp lies along the trend of a branch of the Rose Canyon Fault Zone. Radiocarbon ages of sediment overlying this slide indicate the Del Mar slide is approximately 12-16 ka. These large slide complexes have several characteristics in common. Nearly all occur in areas of tectonic uplift. All of the complexes show evidence of recurrent slide activity, exhibiting multiple headwall scarps and debris lobes, and where available, high-resolution seismic-reflection profiles of these slide areas provide evidence of older, buried mass transport deposits. Assuming typical sedimentation rates, the recurrence interval of

  5. Optimal second order sliding mode control for nonlinear uncertain systems.

    PubMed

    Das, Madhulika; Mahanta, Chitralekha

    2014-07-01

    In this paper, a chattering free optimal second order sliding mode control (OSOSMC) method is proposed to stabilize nonlinear systems affected by uncertainties. The nonlinear optimal control strategy is based on the control Lyapunov function (CLF). For ensuring robustness of the optimal controller in the presence of parametric uncertainty and external disturbances, a sliding mode control scheme is realized by combining an integral and a terminal sliding surface. The resulting second order sliding mode can effectively reduce chattering in the control input. Simulation results confirm the supremacy of the proposed optimal second order sliding mode control over some existing sliding mode controllers in controlling nonlinear systems affected by uncertainty.

  6. An adaptive supervisory sliding fuzzy cerebellar model articulation controller for sensorless vector-controlled induction motor drive systems.

    PubMed

    Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

    2015-01-01

    This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes--the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC--were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes. PMID:25815450

  7. An Adaptive Supervisory Sliding Fuzzy Cerebellar Model Articulation Controller for Sensorless Vector-Controlled Induction Motor Drive Systems

    PubMed Central

    Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

    2015-01-01

    This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes—the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC—were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes. PMID:25815450

  8. Type 2 diabetes mellitus and Invokana: an FDA approved drug.

    PubMed

    Akhtar, Nida

    2013-11-01

    Diabetes Mellitus is a chronic metabolic disease affecting wide range of people across the globe. In India the rate of subjects being suffered from diabetes is continuously increasing. So, the development of drugs for its effective treatment is essential. Thereby, various attempts have been made to discover newer drugs, to reduce the rate of anti diabetic occurrence. Anti-diabetic drugs were found to treat diabetes mellitus by lowering glucose levels in the blood. Both the use antidiabetic drugs as well as the changes in lifestyle and proper diet can significantly affect the severity of diabetes mellitus and also reduces the symptoms and occurrence of the disease. Researches in the past few years on diabetes mellitus showed that this disease is spreading at a very faster rate, thereby; various attempts have been made to treat it efficaciously. Development and approval of antidiabetic drugs is quite necessary. There are different classes of anti-diabetic drugs reported to treat diabetes. The objective of the present review is to explore Invokana as a newly approved antidiabetic drug for the effective treatment of type 2 diabetes. This review focuses mainly on the various aspects of diabetes mellitus and its treatment perspectives. From the various clinical studies done on Invokana, it was concluded that and Invokana was found to be very effective for the efficacious therapy of diabetes mellitus.

  9. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Implementation of the Fee... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  10. 77 FR 70955 - FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 FDA Actions Related to Nicotine Replacement... public on FDA consideration of applicable approval mechanisms and additional indications for nicotine..., including nicotine-containing gums, patches, and lozenges, are already marketed for smoking cessation....

  11. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  12. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation.

    PubMed

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-03-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  13. Sliding mode control of wind-induced vibrations using fuzzy sliding surface and gain adaptation

    NASA Astrophysics Data System (ADS)

    Thenozhi, Suresh; Yu, Wen

    2016-04-01

    Although fuzzy/adaptive sliding mode control can reduce the chattering problem in structural vibration control applications, they require the equivalent control and the upper bounds of the system uncertainties. In this paper, we used fuzzy logic to approximate the standard sliding surface and designed a dead-zone adaptive law for tuning the switching gain of the sliding mode control. The stability of the proposed controller is established using Lyapunov stability theory. A six-storey building prototype equipped with an active mass damper has been used to demonstrate the effectiveness of the proposed controller towards the wind-induced vibrations.

  14. Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

    NASA Technical Reports Server (NTRS)

    Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

    2007-01-01

    Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training

  15. How to Prepare Clay-Lift and Sandwich Slides.

    ERIC Educational Resources Information Center

    Barman, Charles R.

    1984-01-01

    Describes two techniques for making 35 millimeter slides without using photographic film. One method uses clear adhesive contact paper and the other uses transparency film. Both techniques are inexpensive and require only a few minutes of preparation per slide. (JM)

  16. 45. March 26, 1935 View of the big slide of ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    45. March 26, 1935 View of the big slide of several hundred cubic yards of rock, spring of 1934. Another slide occurred at this same location on May 26, 1935. - Scotts Bluff Summit Road, Gering, Scotts Bluff County, NE

  17. Ceramic wear in indentation and sliding

    NASA Technical Reports Server (NTRS)

    Miyoshi, K.; Buckley, D. H.

    1984-01-01

    The various wear mechanisms involved with single-crystal ceramic materials in indentation and in sliding contacts. Experiments simulating interfacial events have been conducted with hemispherical, conical and pyramidal indenters (riders). With spherical riders, under either abrasive or adhesive conditions, two types of fracture pits have been observed. First, spherical-shaped fracture pits and wear particles are found as a result of either indenting or sliding. These are shown to be due to a spherical-shaped fracture along the circular or spherical stress trajectories. Second, polyhedral fracture pits and debris, produced by anisotropic fracture, and also found both during indenting and sliding. These are primarily controlled by surface and subsurface cracking along cleavage planes. Several quantitative results have also been obtained from this work. For example, using a pyramidal diamond, crack length of Mn-Zn ferrite in the indentation process grows linearly with increasing normal load. Moreover, the critical load to fracture both in indentation and sliding is essentially isotropic and is found to be directly proportional to the indenter radius.

  18. Enhancing Creative Thinking through Designing Electronic Slides

    ERIC Educational Resources Information Center

    Mokaram, Al-Ali Khaled; Al-Shabatat, Ahmad Mohammad; Fong, Fook Soon; Abdallah, Andaleeb Ahmad

    2011-01-01

    During the shifting of teaching and learning methods using computer technologies, much emphasis was paid on the knowledge content more than the thinking skills. Thus, this study investigated the effects of a computer application, namely, designing electronic slides on the development of creative thinking skills of a sample of undergraduate…

  19. Simulation of sliding of liquid droplets

    NASA Astrophysics Data System (ADS)

    Alen, Saif Khan; Farhat, Nazia; Rahman, Md. Ashiqur

    2016-07-01

    Numerical simulations of sliding behavior of liquid droplets on flat and periodic microgrooved surfaces with a range of groove geometry are conducted. A numerical model is developed which is capable of predicting the critical sliding angle of the drop by comparing the advancing and the receding angles obtained from numerical and experimental findings. The effect of microgroove topography, droplet size and inclination angle on the droplet sliding characteristics is analysed. Using an open-source platform (Surface Evolver), a 3D drop-shape model is developed to numerically determine the drop stability and contact angle hysteresis on tilted surfaces. In this numerical model, the three phase contact line of the drop is obtained by numerically calculating the vertex force and local contact angle at each vertex of the base contour. Several numerical models are developed based on various assumptions of base contour shape (circular or elliptical) and implementation of gravitational force to the droplet. Droplet shapes and critical sliding angles, obtained from these numerical models, are compared with those of experimental results and are found to be in very good agreement.

  20. Particle Sliding on a Rough Incline

    ERIC Educational Resources Information Center

    Zurcher, Ulrich

    2007-01-01

    We study a particle sliding on a rough inclined plane as an example of a mechanical problem with nonholonomic constraint. The particle is launched in an arbitrary direction so that its motion has both a horizontal and a "vertical" (i.e., up- and downhill) direction. The friction force acts along the instantaneous velocity, so that the horizontal…

  1. Color Microfiche as a Replacement for Slides.

    ERIC Educational Resources Information Center

    Schwarz, Philip

    This is the summary of a larger paper describing the evolution of a mediated elementary accounting course at the University of Wisconsin-Stout. The course was initially developed as a 25 slide-tape lesson course which included 950 visuals and approximately 25 hours of instruction. One hundred students per semester took the course in the following…

  2. Four Key Keys to Powerful Presentations in PowerPoint: Take Your Presentations to the Next Level

    ERIC Educational Resources Information Center

    Howell, Dusti D.

    2008-01-01

    If a person is on a presentation and he/she does not know how to go back to a previous PowerPoint slide, his/her credibility will be clouded and the audience will become frustrated. More sophisticated presenters use handheld remotes to control the basic navigation of slides. Even in this case, keyboard shortcuts can be an added benefit. For those…

  3. Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

    PubMed Central

    Kim, Hyosun

    2015-01-01

    Background: For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. Methods: The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Results: Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion: Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus

  4. Rolling motion: experiments and simulations focusing on sliding friction forces

    NASA Astrophysics Data System (ADS)

    Onorato, Pasquale; Malgieri, Massimiliano; De Ambrosis, Anna

    2016-05-01

    The paper presents an activity sequence aimed at elucidating the role of sliding friction forces in determining/shaping the rolling motion. The sequence is based on experiments and computer simulations and it is devoted both to high school and undergraduate students. Measurements are carried out by using the open source Tracker Video Analysis software, while interactive simulations are realized by means of Algodoo, a freeware 2D-simulation software. Data collected from questionnaires before and after the activities, and from final reports, show the effectiveness of combining simulations and Video Based Analysis experiments in improving students' understanding of rolling motion.

  5. Experimental Study of Sliding Friction for PET Track Membranes

    NASA Astrophysics Data System (ADS)

    Filippova, E. O.; Filippov, A. V.; Shulepov, I. A.

    2016-04-01

    The article is presented results of a study of the process for a dry friction metal-polymer couple on scheme disc-finger. Track membrane from polyethylene terephthalate was a research material. Membrane had pores with 0.4 and 0.8 μm diameters. The effect of the sliding velocity for membranes with pores of 0.8 microns was determined. Research was shown that increasing pore’s diameter caused a reduction of the friction coefficient and downturn its magnitude vibrations. The study showed that track membrane have adequate resistance to wear and can be successfully used in surgical procedures in the layers of the cornea.

  6. Risk Analysis for Unintentional Slide Deployment During Airline Operations.

    PubMed

    Ayra, Eduardo S; Insua, David Ríos; Castellanos, María Eugenia; Larbi, Lydia

    2015-09-01

    We present a risk analysis undertaken to mitigate problems in relation to the unintended deployment of slides under normal operations within a commercial airline. This type of incident entails relevant costs for the airline industry. After assessing the likelihood and severity of its consequences, we conclude that such risks need to be managed. We then evaluate the effectiveness of various countermeasures, describing and justifying the chosen ones. We also discuss several issues faced when implementing and communicating the proposed measures, thus fully illustrating the risk analysis process.

  7. Adaptive second-order sliding mode control with uncertainty compensation

    NASA Astrophysics Data System (ADS)

    Bartolini, G.; Levant, A.; Pisano, A.; Usai, E.

    2016-09-01

    This paper endows the second-order sliding mode control (2-SMC) approach with additional capabilities of learning and control adaptation. We present a 2-SMC scheme that estimates and compensates for the uncertainties affecting the system dynamics. It also adjusts the discontinuous control effort online, so that it can be reduced to arbitrarily small values. The proposed scheme is particularly useful when the available information regarding the uncertainties is conservative, and the classical `fixed-gain' SMC would inevitably lead to largely oversized discontinuous control effort. Benefits from the viewpoint of chattering reduction are obtained, as confirmed by computer simulations.

  8. ArrayTrack: a free FDA bioinformatics tool to support emerging biomedical research--an update.

    PubMed

    Xu, Joshua; Kelly, Reagan; Fang, Hong; Tong, Weida

    2010-08-01

    ArrayTrack is a Food and Drug Administration (FDA) bioinformatics tool that has been widely adopted by the research community for genomics studies. It provides an integrated environment for microarray data management, analysis and interpretation. Most of its functionality for statistical, pathway and gene ontology analysis can also be applied independently to data generated by other molecular technologies. ArrayTrack has been undergoing active development and enhancement since its inception in 2001. This review summarises its key functionalities, with emphasis on the most recent extensions in support of the evolving needs of FDA's research programmes. ArrayTrack has added capability to manage, analyse and interpret proteomics and metabolomics data after quantification of peptides and metabolites abundance, respectively. Annotation information about single nucleotide polymorphisms and quantitative trait loci has been integrated to support genetics-related studies. Other extensions have been added to manage and analyse genomics data related to bacterial food-borne pathogens.

  9. Repurposing FDA-approved drugs as therapeutics to treat Rift Valley fever virus infection

    PubMed Central

    Benedict, Ashwini; Bansal, Neha; Senina, Svetlana; Hooper, Idris; Lundberg, Lindsay; de la Fuente, Cynthia; Narayanan, Aarthi; Gutting, Bradford; Kehn-Hall, Kylene

    2015-01-01

    There are currently no FDA-approved therapeutics available to treat Rift Valley fever virus (RVFV) infection. In an effort to repurpose drugs for RVFV treatment, a library of FDA-approved drugs was screened to determine their ability to inhibit RVFV. Several drugs from varying compound classes, including inhibitors of growth factor receptors, microtubule assembly/disassembly, and DNA synthesis, were found to reduce RVFV replication. The hepatocellular and renal cell carcinoma drug, sorafenib, was the most effective inhibitor, being non-toxic and demonstrating inhibition of RVFV in a cell-type and virus strain independent manner. Mechanism of action studies indicated that sorafenib targets at least two stages in the virus infectious cycle, RNA synthesis and viral egress. Computational modeling studies also support this conclusion. siRNA knockdown of Raf proteins indicated that non-classical targets of sorafenib are likely important for the replication of RVFV. PMID:26217313

  10. Screening of FDA-Approved Drugs for Treatment of Emerging Pathogens.

    PubMed

    Sisk, Jeanne M; Frieman, Matthew B

    2015-09-11

    The current outbreaks of Middle East Respiratory Syndrome (MERS) and Ebolavirus (EboV) have revealed a gap in the development and availability of drugs to treat these infections. To date, there are no approved treatments for patients infected with MERS coronavirus (MERS-CoV), a virus that continues to infect new patients and that has now spread from the Middle East to Asia. Despite a downward trend in the number of new EboV cases in West Africa, new infections are still occurring, and many patients continue to suffer from this illness. People infected with MERS and Ebola viruses receive only supportive care in hopes of recovery. Investigation into repurposing drugs approved by the FDA is gaining interest. To identify better treatment strategies, several groups have used drug screens to repurpose FDA-approved drugs as inhibitors of MERS-CoV and EboV. PMID:27617922

  11. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

    PubMed

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses. PMID:22400144

  12. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    PubMed

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources. PMID:19042521

  13. Killing with kindness: why the FDA need not certify drugs used for execution safe and effective.

    PubMed

    Annas, G J

    1985-09-01

    In 1977, Texas and Oklahoma became the first states to legalize administration of the death penalty by lethal injection; by late 1985, 14 other states had followed suit. Opponents of the death penalty petitioned the Food and Drug Administration in 1980 to declare drugs specified for use in executions as "not approved," and to prevent their use for that purpose. When the FDA denied their request, the petitioners took legal action against the agency, eventually arguing their case before the U.S. Supreme Court, which ruled against them in Heckler v. Chaney (1985). Annas discusses the Court's action, which dealt only with the judicial reviewability under federal statute of the FDA's decision not to exercise its authority over the use of drugs in interstate commerce. He notes that, by dealing only with procedural issues, the Court avoided ruling on the death penalty itself.

  14. Bodies of evidence: activists, patients, and the FDA regulation of Depo-Provera.

    PubMed

    Kline, Wendy

    2010-01-01

    In January 1983, the FDA held one of only two scientific "Public Boards of Inquiry" in the history of the administration to determine whether to approve Depo-Provera for use as a contraceptive in the United States. At the hearing, ideas about gender and power played a central role in negotiations between scientists, doctors, patients, and women's health activists. The nature of the Depo-Provera Public Board of Inquiry lends itself to analysis of the interaction between and among these groups, each of which had a vested interest in the outcome of the FDA decision. The stories and strategies emerging from the actors involved in the Public Board of Inquiry reveal the enormous complexity of regulating reproduction in the late twentieth century.

  15. FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys | Division of Cancer Prevention

    Cancer.gov

    The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |

  16. [Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case].

    PubMed

    Tang, Jian-yuan; Huang, Fang-hua; Zhu, Fei-peng

    2009-11-01

    FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.

  17. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health

    SciTech Connect

    Not Available

    1983-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section VI provides those chapters of the Compliance Program Guidance Manual which pertain to the area of radiological health. Some of the areas of coverage include laser standards; compliance testing of x-ray equipment, ultrasonic therapy devices, mercury vapor lamps, television receivers, and microwave ovens; radiation policy; and imported electronic products.

  18. FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine.

    PubMed

    Trumbo, Paula R

    2016-09-01

    The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, "This salt does not supply iodide, a necessary nutrient." If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

  19. FDA Approves Test to Aid Post-PSA Biopsy Decisions | Division of Cancer Prevention

    Cancer.gov

    The Food and Drug Administration (FDA) has approved a test to help men with elevated prostate-specific antigen (PSA) test scores decide whether to have a biopsy to test for prostate cancer. The Access Hybritech p2PSA test is approved for use in men aged 50 or older who have a PSA test score between 4 and 10 ng/ml but who show no signs of cancer during a digital rectal exam. |

  20. Adaptive Actor-Critic Design-Based Integral Sliding-Mode Control for Partially Unknown Nonlinear Systems With Input Disturbances.

    PubMed

    Fan, Quan-Yong; Yang, Guang-Hong

    2016-01-01

    This paper is concerned with the problem of integral sliding-mode control for a class of nonlinear systems with input disturbances and unknown nonlinear terms through the adaptive actor-critic (AC) control method. The main objective is to design a sliding-mode control methodology based on the adaptive dynamic programming (ADP) method, so that the closed-loop system with time-varying disturbances is stable and the nearly optimal performance of the sliding-mode dynamics can be guaranteed. In the first step, a neural network (NN)-based observer and a disturbance observer are designed to approximate the unknown nonlinear terms and estimate the input disturbances, respectively. Based on the NN approximations and disturbance estimations, the discontinuous part of the sliding-mode control is constructed to eliminate the effect of the disturbances and attain the expected equivalent sliding-mode dynamics. Then, the ADP method with AC structure is presented to learn the optimal control for the sliding-mode dynamics online. Reconstructed tuning laws are developed to guarantee the stability of the sliding-mode dynamics and the convergence of the weights of critic and actor NNs. Finally, the simulation results are presented to illustrate the effectiveness of the proposed method.

  1. Adaptive Actor-Critic Design-Based Integral Sliding-Mode Control for Partially Unknown Nonlinear Systems With Input Disturbances.

    PubMed

    Fan, Quan-Yong; Yang, Guang-Hong

    2016-01-01

    This paper is concerned with the problem of integral sliding-mode control for a class of nonlinear systems with input disturbances and unknown nonlinear terms through the adaptive actor-critic (AC) control method. The main objective is to design a sliding-mode control methodology based on the adaptive dynamic programming (ADP) method, so that the closed-loop system with time-varying disturbances is stable and the nearly optimal performance of the sliding-mode dynamics can be guaranteed. In the first step, a neural network (NN)-based observer and a disturbance observer are designed to approximate the unknown nonlinear terms and estimate the input disturbances, respectively. Based on the NN approximations and disturbance estimations, the discontinuous part of the sliding-mode control is constructed to eliminate the effect of the disturbances and attain the expected equivalent sliding-mode dynamics. Then, the ADP method with AC structure is presented to learn the optimal control for the sliding-mode dynamics online. Reconstructed tuning laws are developed to guarantee the stability of the sliding-mode dynamics and the convergence of the weights of critic and actor NNs. Finally, the simulation results are presented to illustrate the effectiveness of the proposed method. PMID:26357411

  2. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    PubMed Central

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  3. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

    PubMed

    Rosania, Larry

    2010-01-01

    Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective. PMID:24479237

  4. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    PubMed

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

  5. The role of data audits in detecting scientific misconduct. Results of the FDA program.

    PubMed

    Shapiro, M F; Charrow, R P

    1989-05-01

    To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly.

  6. The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization.

    PubMed

    Gruber, Marion F

    2015-11-25

    The FDA has responsibility for ensuring that prescription drug and biological products including vaccines are accompanied by labeling that summarizes scientific information concerning their safe and effective use. As part of a broader effort to improve the content and format of prescription drug labeling FDA published a final rule, the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the "Pregnancy and Lactation Labeling Rule (PLLR)." The most significant change to be implemented by this Rule is the removal of the letter risk categories A, B, C, D and X from all labeling, replacing them with a narrative summary of the risks of using a drug or biological product including vaccines during pregnancy. The PLLR requires an evaluation of available information about a product's use in pregnancy and provides an opportunity to update labeling when new information about use of a vaccine in pregnancy becomes available. Implementation of the provisions articulated in the PLLR, as they apply to vaccine product labeling, will require close collaboration between FDA and the vaccine manufacturer for both currently licensed vaccines and those in development.

  7. Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor.

    PubMed

    Arns, Martijn; Loo, Sandra K; Sterman, M Barry; Heinrich, Hartmut; Kuntsi, Jonna; Asherson, Philip; Banaschewski, Tobias; Brandeis, Daniel

    2016-05-01

    Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD Assessment Aid (NEBA) Health test. The NEBA test relies upon an EEG-based measure, called the theta to beta ratio (TBR). Although this measure has yielded large differences between ADHD and non-ADHD groups in studies prior to 2009, recent studies and a meta-analysis could not replicate these findings. In this article, we have used the NEBA device as an exemplar for a discussion that distinguishes between FDA de novo marketing approval for a device and any claims that that device is empirically supported, scientifically validated with replicated findings. It is understood that the aims of each differ; however, for many, including the lay public as well as some mental health professionals, these terms may be confused and treated as though they are synonymous. With regard to the TBR measure, there is no reliable association or replication for its clinical usage in the ADHD diagnostic process. The recommendation for potential consumers of the NEBA Health test (as well as perhaps for other existing FDA-approved diagnostic tests) is caveat emptor (let the buyer beware!). PMID:27090383

  8. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

    PubMed

    Rosania, Larry

    2010-01-01

    Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

  9. Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008

    PubMed Central

    Kornfield, Rachel; Watson, Sydeaka; Higashi, Ashley S.; Conti, Rena M.; Dusetzina, Stacie B.; Garfield, Craig F.; Dorsey, E. Ray; Huskamp, Haiden A.; Alexander, G. Caleb

    2014-01-01

    Objective This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. Methods Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. Results In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies—clonidine, guanfacine, and bupropion—was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. Conclusions FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit. PMID:23318985

  10. Stability of sliding Couette-Poiseuille flow in an annulus subject to axisymmetric and asymmetric disturbances

    NASA Astrophysics Data System (ADS)

    Sadeghi, Venus M.; Higgins, Brian G.

    1991-09-01

    The linear stability of pressure-driven flow between a sliding inner cylinder and a stationary outer cylinder is studied numerically. Attention is restricted to axisymmetric disturbances (n=0), and asymmetric disturbances with azimuthal wave numbers n=1, 2, and 3. Neutral stability curves in the Reynolds number versus the wave-number plane are presented as a function of the sliding velocity of the inner cylinder for select values of the radius ratio κ. Overall, the sliding velocity of the inner cylinder has a net stabilizing effect on all modes studied. Results presented for κ=2 show that individual disturbance modes can be completely stabilized by increasing the sliding velocity. In particular, when the sliding velocity is approximately 25% of the maximum Poiseuille velocity, the neutral curve for the n=2 mode vanishes; at 36% of the maximum Poiseuille velocity, the neutral curve for the n=0 mode vanishes, and at 65%, the neutral curve for the n=1 mode vanishes. For a stationary inner cylinder the asymmetric modes are generally the least stable, though this conclusion does depend on the magnitude of κ. As κ→1 the axisymmetric mode is found to be the most dangerous.

  11. Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

    PubMed

    Pelletier, David L

    2005-05-01

    The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

  12. Apparatus for correcting precision errors in slide straightness in machine tools

    DOEpatents

    Robinson, Samuel C.; Gerth, Howard L.

    1981-01-01

    The present invention is directed to a mechanism by which small deviations in slideway straightness and roll of a precision machining apparatus may be compensated for. The mechanism of the present invention comprises a fixture support disposed between the slideway carriage and the tool or workpiece fixture and provided with a hinge-like coupling between the carriage and the fixture support so as to allow for the minute and precise displacement of the fixture support in a direction normal to the direction of the slide path so as to readily compensate for slight deviations in the straightness and roll of the slide path.

  13. Apparatus for correcting precision errors in slide straigntness in machine tools

    DOEpatents

    Robinson, S.C.; Gerth, H.L.

    The present invention is directed to a mechanism by which small deviations in slideway straightness and roll of a precision machining apparatus may be compensated for. The mechanism of the present invention comprises a fixture support disposed between the slideway carriage and the tool or workpiece fixture and provided with a hinge-like coupling between the carriage and the fixture support so as to allow for the minute and precise displacement of the fixture support in a direction normal to the direction of the slide path soa as to readily compensate for slight deviations in the straightness and roll of the slide path.

  14. Certainty equivalence adaptation combined with super-twisting sliding-mode control

    NASA Astrophysics Data System (ADS)

    Barth, A.; Reichhartinger, M.; Wulff, K.; Horn, M.; Reger, J.

    2016-09-01

    In this paper, a Lyapunov-based control concept is presented that combines variable structure and adaptive control. The considered system class consists of nonlinear single input systems which are affected by matched structured and unstructured uncertainties. Resorting to the certainty equivalence principle, the controller exploits advantages of both the sliding-mode and the adaptive control methodology. It is demonstrated that the gains of the discontinuous control action may be reduced remarkably when compared with pure sliding-mode-based approaches. The efficiency of the presented concept is demonstrated in detail, using results of numerical simulations.

  15. Smith predictor based-sliding mode controller for integrating processes with elevated deadtime.

    PubMed

    Camacho, Oscar; De la Cruz, Francisco

    2004-04-01

    An approach to control integrating processes with elevated deadtime using a Smith predictor sliding mode controller is presented. A PID sliding surface and an integrating first-order plus deadtime model have been used to synthesize the controller. Since the performance of existing controllers with a Smith predictor decrease in the presence of modeling errors, this paper presents a simple approach to combining the Smith predictor with the sliding mode concept, which is a proven, simple, and robust procedure. The proposed scheme has a set of tuning equations as a function of the characteristic parameters of the model. For implementation of our proposed approach, computer based industrial controllers that execute PID algorithms can be used. The performance and robustness of the proposed controller are compared with the Matausek-Micić scheme for linear systems using simulations. PMID:15098585

  16. Smith predictor based-sliding mode controller for integrating processes with elevated deadtime.

    PubMed

    Camacho, Oscar; De la Cruz, Francisco

    2004-04-01

    An approach to control integrating processes with elevated deadtime using a Smith predictor sliding mode controller is presented. A PID sliding surface and an integrating first-order plus deadtime model have been used to synthesize the controller. Since the performance of existing controllers with a Smith predictor decrease in the presence of modeling errors, this paper presents a simple approach to combining the Smith predictor with the sliding mode concept, which is a proven, simple, and robust procedure. The proposed scheme has a set of tuning equations as a function of the characteristic parameters of the model. For implementation of our proposed approach, computer based industrial controllers that execute PID algorithms can be used. The performance and robustness of the proposed controller are compared with the Matausek-Micić scheme for linear systems using simulations.

  17. Exit Presentation -- Maintaining Balance

    NASA Technical Reports Server (NTRS)

    Heap, Erin

    2010-01-01

    This slide presentation reviews the projects which the author engaged in during an internship at Johnson Space Center. Project 1 was involved with Stochastic Resonance (SR). Stochastic resonance is a phenomenon in which the response of a non-linear system to a weak input signal is optimized by the presence of a particular non-zero level of noise. The goal of this project was to develop a countermeasure for sensorimotor disturbances that are experienced after long duration space flight. The second project was a pilot study that was to examine how adaptation to a novel functional task was affected by postural disturbance.

  18. Texturing in metals as a result of sliding

    NASA Technical Reports Server (NTRS)

    Wheeler, D. R.; Buckley, D. H.

    1973-01-01

    Sliding friction experiments were conducted with copper, nickel, iron, and cobalt sliding on themselves in air and argon. The resulting wear surfaces were examined with X-ray analysis to determine if surface texturing had occurred as a result of sliding. Results of the investigation indicate that, for the face-centered-cubic metals copper and nickel, a (111) texture develops with the (111) planes tilted 10 deg in the direction of sliding. The body-centered-cubic metal iron exhibited a (110) texture with the (100) direction oriented in the direction of sliding. It also exhibited a 10 deg tilt in the direction of sliding. The environment influenced the results in that the degree of texture observed in argon was less than that seen in air for iron. No texturing was observed for the close-packed-hexagonal metal cobalt. Recrystallization was observed with copper as a result of sliding.

  19. Sliding friction on wet and dry sand.

    PubMed

    Fall, A; Weber, B; Pakpour, M; Lenoir, N; Shahidzadeh, N; Fiscina, J; Wagner, C; Bonn, D

    2014-05-01

    We show experimentally that the sliding friction on sand is greatly reduced by the addition of some-but not too much-water. The formation of capillary water bridges increases the shear modulus of the sand, which facilitates the sliding. Too much water, on the other hand, makes the capillary bridges coalesce, resulting in a decrease of the modulus; in this case, we observe that the friction coefficient increases again. Our results, therefore, show that the friction coefficient is directly related to the shear modulus; this has important repercussions for the transport of granular materials. In addition, the polydispersity of the sand is shown to also have a large effect on the friction coefficient. PMID:24836256

  20. Plastic deformation at surface during unlubricated sliding

    NASA Technical Reports Server (NTRS)

    Yamamoto, T.; Buckley, D. H.

    1982-01-01

    The plastic deformation and wear of 304 stainless-steel surface slid against an aluminum oxide rider were observed by using a scanning electron microscope and an optical microscope. Experiments were conducted in a vacuum of 0.000001 Pa and in an environment of 0.0005 Pa chlorine gas at 25 C. The load was 500 grams and the sliding velocity was 0.5 centimeter per second. The deformed surface layer which accumulates and develops successively is left behind the rider, and step-shaped protuberances are developed even after single pass sliding under both environmental conditions. A fully developed surface layer is gradually torn off leaving a characteristic pattern. These observations result from both adhesion and an adhesive wear mechanism.

  1. Operational seismic network estimates rock slide properties

    NASA Astrophysics Data System (ADS)

    Schultz, Colin

    2012-02-01

    During the spring of 1991, two subsequent landslides near Randa, Switzerland, dropped 30,000,000 cubic meters of debris on the town below. The rocks dammed the Vispa River, a temporary reservoir that would have failed catastrophically had the army not carved a channel through it. Many rock slides occur in remote alpine locations, so it can sometimes take days or weeks before they are detected, a delay that could have cost the town of Randa. Rock slides can range from deadly, to disruptive, to simple scientific curiosities.Dammeier et al. have developed a method to remotely estimate their volume, location, and runout distances that could potentially be used in real time.

  2. NASA SMD E/PO Community Addresses the needs of the Higher Ed Community: Introducing Slide sets for the Introductory Earth and Space Science Instructor

    NASA Astrophysics Data System (ADS)

    Buxner, S.; Meinke, B. K.; Brain, D.; Schneider, N. M.; Schultz, G. R.; Smith, D. A.; Grier, J.; Shipp, S. S.

    2014-12-01

    The NASA Science Mission Directorate (SMD) Science Education and Public Outreach (E/PO) community and Forums work together to bring the cutting-edge discoveries of NASA Astrophysics and Planetary Science missions to the introductory astronomy college classroom. These mission- and grant-based E/PO programs are uniquely poised to foster collaboration between scientists with content expertise and educators with pedagogy expertise. We present two new opportunities for college instructors to bring the latest NASA discoveries in Space Science into their classrooms. The NASA Science Mission Directorate (SMD) Astrophysics Education and Public Outreach Forum is coordinating the development of a pilot series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The "Astro 101 slide sets" are presentations 5-7 slides in length on a new development or discovery from a NASA Astrophysics mission relevant to topics in introductory astronomy courses. We intend for these slide sets to help Astronomy 101 instructors include new developments (discoveries not yet in their textbooks) into the broader context of the course. In a similar effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division of Planetary Sciences (DPS) has developed the Discovery slide sets, which are 3-slide presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides which cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and sets are available in Farsi and Spanish. The NASA SMD Planetary Science Forum has recently partnered with the DPS to continue producing the

  3. [Neuropathological perspective on single slide].

    PubMed

    Hirano, Asao

    2008-11-01

    During over 50 years of my career in Neuropathology at Montefiore Medical Center in New York, I have come across certain interesting neuropathological findings. In this communication, some photographs showing macroscopic, microscopic and electron microscopic significant findings are selected to illustrate the usefulness, not only for the diagnosis but also for the understanding of the nervous system. The 11 topics presented in this paper are: (1) alteration of dura mater associated with advanced aging; (2) orderly arrangement of tumor cells in leptomeningeal carcinomatosis; (3) horizontal section of brain with border zone infarct; (4) neurofibrillary tangle formation in the nucleus basalis Meynert ipsilateral to a massive cerebral infarct; (5) extracellular spread of hematogenous edema fluid in the white matter: (6) unrolled myelin sheath: (7) unattached presynaptic terminals in cerebellar neuroblastoma: (8) unattached post synaptic terminals in agranular cerebellar degeneration: (9) neurofibrillary tangles and Lewy bodes in a single neuron: (10) Cu/Zu superoxide dismutase positive Lewy body-like hyaline inclusions in anterior horn cells in familial motor neuron disease: (11) Hirano body. Analysis of these findings are presented for an educational purpose. PMID:19198088

  4. Dry Sliding Wear Characteristics of Ti-6.5Al-3.5Mo-1.5Zr-0.3Si Alloy at Various Sliding Speeds

    NASA Astrophysics Data System (ADS)

    Li, X. X.; Zhou, Y.; Li, Y. X.; Ji, X. L.; Wang, S. Q.

    2015-09-01

    Dry sliding wear behavior of Ti-6.5Al-3.5Mo-1.5Zr-0.3Si (hereafter called TC11) alloy was investigated under various sliding speeds and distances. TC11 alloy presented marked variations of the wear rate with an increase of sliding speed from 0.5 to 4 m/s. Especially at high loads, a severe-to-mild wear transition occurred with the climax at 2.68 m/s, the lower values were at 0.5 to 1.5 m/s, and the lowest point was at 4 m/s. TC11 alloy also presented a mild-to-severe wear transition at 2.68 m/s with an increase of sliding distance, but not at the others. With a thorough examination for worn surfaces, subsurfaces and wear debris, the distinct characteristics were noticed to correspond to the wear behavior in various conditions. The highest wear rate at 2.68 m/s and the lowest wear rate at 4 m/s, respectively, corresponded to no oxides and large wear debris particles as well as more oxides and small wear debris particles. The tribo-oxides formed at room temperature were suggested to be protective, which seemed to be contradictory to the popular view that tribo-oxides of titanium alloys possess no wear-reducing effect.

  5. Sliding mode control of electromagnetic tethered satellite formation

    NASA Astrophysics Data System (ADS)

    Hallaj, Mohammad Amin Alandi; Assadian, Nima

    2016-08-01

    This paper investigates the control of tethered satellite formation actuated by electromagnetic dipoles and reaction wheels using the robust sliding mode control technique. Generating electromagnetic forces and moments by electric current coils provides an attractive control actuation alternative for tethered satellite system due to the advantages of no propellant consumption and no obligatory rotational motion. Based on a dumbbell model of tethered satellite in which the flexibility and mass of the tether is neglected, the equations of motion in Cartesian coordinate are derived. In this model, the J2 perturbation is taken into account. The far-field and mid-field models of electromagnetic forces and moments of two satellites on each other and the effect of the Earth's magnetic field are presented. A robust sliding mode controller is designed for precise trajectory tracking purposes and to deal with the electromagnetic force and moment uncertainties and external disturbances due to the Earth's gravitational and magnetic fields inaccuracy. Numerical simulation results are presented to validate the effectiveness of the developed controller and its superiority over the linear controller.

  6. Characterization of Instructor and Student Use of Ubiquitous Presenter, a Presentation System Enabling Spontaneity and Digital Archiving

    NASA Astrophysics Data System (ADS)

    Price, Edward; Malani, Roshni; Simon, Beth

    2007-01-01

    Ubiquitous Presenter (UP) is a digital presentation system that allows an instructor with a Tablet PC to spontaneously modify prepared slides, while automatically archiving the inked slides on the web. For two introductory physics classes, we examine the types of slides instructors prepare and the ways in which they add ink to the slides. Modes of usage include: using ink to explicitly link multiple representations; making prepared figures dynamic by animating them with ink; and preparing slides with sparse text or figures, then adding extensive annotations during class. In addition, through an analysis of surveys and of web server logs, we examine student reaction to the system, as well as how often and in what ways students' utilize archived material. In general, students find the system valuable and frequently review the presentations online.

  7. Contact forces at the sliding interface: Mixed versus pure model alkane monolayers

    NASA Astrophysics Data System (ADS)

    Mikulski, Paul T.; Gao, Guangtu; Chateauneuf, Ginger M.; Harrison, Judith A.

    2005-01-01

    Classical molecular dynamics simulations of an amorphous carbon tip sliding against monolayers of n-alkane chains are presented. The tribological behavior of tightly packed, pure monolayers composed of chains containing 14 carbon atoms is compared to mixed monolayers that randomly combine equal amounts of 12- and 16-carbon-atom chains. When sliding in the direction of chain cant under repulsive (positive) loads, pure monolayers consistently show lower friction than mixed monolayers. The distribution of contact forces between individual monolayer chain groups and the tip shows pure and mixed monolayers resist tip motion similarly. In contrast, the contact forces "pushing" the tip along differ in the two monolayers. The pure monolayers exhibit a high level of symmetry between resisting and pushing forces which results in a lower net friction. Both systems exhibit a marked friction anisotropy. The contact force distribution changes dramatically as a result of the change in sliding direction, resulting in an increase in friction. Upon continued sliding in the direction perpendicular to chain cant, both types of monolayers are often capable of transitioning to a state where the chains are primarily oriented with the cant along the sliding direction. A large change in the distribution of contact forces and a reduction in friction accompany this transition.

  8. Dry sliding wear behavior of epoxy composite reinforced with short palmyra fibers

    NASA Astrophysics Data System (ADS)

    Biswal, Somen; Satapathy, Alok

    2016-02-01

    The present work explores the possibility of using palmyra fiber as a replacement for synthetic fiber in conventional polymer composites for application against wear. An attempt has been made in this work to improve the sliding wear resistance of neat epoxy by reinforcing it with short palmyra fibers (SPF). Epoxy composites with different proportions (0, 4, 8 and 12 wt. %) of SPF are fabricated by conventional hand lay-up technique. Dry sliding wear tests are performed on the composite samples using a pin-on-disc test rig as per ASTM G 99-05 standards under various operating parameters. Design of experiment approach based on Taguchi's L16 Orthogonal Arrays is used for the analysis of the wear. This parametric analysis reveals that the SPF content is the most significant factor affecting the wear process followed by the sliding velocity. The sliding wear behavior of these composites under an extensive range of test conditions is predicted by a model based on the artificial neural network (ANN). A well trained ANN has been used to predict the sliding wear response of epoxy based composites over a wide range.

  9. A multitask sliding mode control for mismatched uncertain large-scale systems

    NASA Astrophysics Data System (ADS)

    Tsai, Yao-Wen; Van Huynh, Van

    2015-09-01

    A new sliding mode control (SMC) approach, output variables only, single phase only and chattering phenomenon free, is presented for a class of mismatched uncertain large-scale systems. For a new multitask SMC, it is not required that the system states are available. Moreover, the sliding function in this study just depends on output variables. Using an exponential type sliding surface, the system states are always in the sliding mode at the beginning time t = 0. Using a newly appropriate linear matrix inequality stability conditions by the Lyapunov method are derived such that each subsystem in the new sliding mode is completely invariant to matched uncertainties. As a result, robustness of the mismatched uncertain large-scale systems can be assured throughout an entire response of the system starting from the initial time t = 0. In every subsystem, a scheme of decentralised control using only output states is proposed. In addition, a continuous controller is finally designed for chattering removal. Finally, a numerical example is used to demonstrate the efficacy of the proposed method.

  10. Rolling vs. Sliding: The inclusion of non-conservative work in the classic comparison

    NASA Astrophysics Data System (ADS)

    Chediak, Alex; Buehler, Terry

    2010-03-01

    A semester-long mechanics course typically covers moment of inertia, angular velocity, and rolling. A classic comparison is made between rolling without slipping and sliding without friction. In either case, no non-conservation work is performed---all the gravitational potential energy that the rolling or sliding object possesses at the top of the incline plane is converted into kinetic energy. In the case of the sliding object, the kinetic energy term is simply .5ex1 -.1em/ -.15em.25ex2 mv^2. In the case of the rolling object, the kinetic energy term is .5ex1 -.1em/ -.15em.25ex2 mv^2 + .5ex1 -.1em/ -.15em.25ex2 Iφ^2. The friction here is static not kinetic, so it does no mechanical work. Since the sliding object has no angular velocity, its linear velocity is greater than that of the rolling object, and it reaches the bottom of the track faster. But if a rolling and sliding object, each of the same material, were to race down an incline plane, which would win? The answer depends on the effective coefficient of friction, C. If C > μs, which will occur at angles approaching 90^o, the rolling object slips. And if C < μk, the rolling object has a greater linear acceleration and wins the race to the bottom. Experimental results to verify a theoretical model (including the dependency on incline angle) will also be presented.

  11. Phosphoproteome analysis of formalin-fixed and paraffin-embedded tissue sections mounted on microscope slides.

    PubMed

    Wakabayashi, Masaki; Yoshihara, Hiroki; Masuda, Takeshi; Tsukahara, Mai; Sugiyama, Naoyuki; Ishihama, Yasushi

    2014-02-01

    Formalin-fixed and paraffin-embedded (FFPE) sections mounted on microscope slides are one of the largest available resources for retrospective research on various diseases, but quantitative phosphoproteome analysis of FFPE sections has never been achieved because of the extreme difficulty of procuring sufficient phosphopeptides from the limited amounts of proteins on the slides. Here, we present the first protocol for quantitative phosphoproteome analysis of FFPE sections by utilizing phase-transfer surfactant-aided extraction/tryptic digestion of FFPE proteins followed by high-recovery phosphopeptide enrichment via lactic acid-modified titania chromatography. We established that FFPE sections retain a similar phosphoproteome to fresh tissue specimens during storage for at least 9 months, confirming the utility of our method for evaluating phosphorylation profiles in various diseases. We also verified that chemical labeling based on reductive dimethylation of amino groups was feasible for quantitative phosphoproteome analysis of FFPE samples on slides. Furthermore, we improved the LC-MS sensitivity by miniaturizing nanoLC columns to 25 μm inner diameter. With this system, we could identify 1090 phosphopeptides from a single FFPE section obtained from a microscope slide, containing 25.2 ± 5.4 μg of proteins. This protocol should be useful for large-scale phosphoproteome analysis of archival FFPE slides, especially scarce samples from patients with rare diseases.

  12. United States FDA's emergency use authorization of Ebola virus diagnostics: current impact and lessons for the future.

    PubMed

    Whitehouse, Chris A; Bavari, Sina; Perkins, Mark D

    2015-01-01

    The Ebola outbreak that took hold in West Africa in 2014 outran the epidemic response capacity of many organizations. Five months after the epidemic was first declared, there were still only two laboratories in West Africa with the capacity to confirm Ebola virus infection. In the summer of 2014, before the first case of imported Ebola occurred in the USA, the US FDA announced it would issue Emergency Use Authorizations for Ebola virus in vitro diagnostics to speed their availability. Between October 2014 and March 2015, the FDA issued Emergency Use Authorizations for nine diagnostic products. The actions of the FDA not only allowed nationwide deployment of Ebola virus testing capacity in the USA but also established an attractive regulatory goalpost for companies developing assays for use in West Africa. Here, we comment on the diagnostic assays for which the FDA has issued emergency authorizations and their fitness for purpose. PMID:26394699

  13. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting--FDA. Direct final rule.

    PubMed

    1998-05-12

    The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives a significant adverse comment and withdraws this direct final rule.

  14. Radiological health; evaluation of radiation exposure in diagnostic radiology examinations; availability of draft recommendations--FDA. Notice.

    PubMed

    1983-07-29

    The Food and Drug Administration (FDA) announces the availability for public review and comment of draft recommendations on evaluation of radiation exposure in diagnostic radiology examinations, prepared by FDA's National Center for Devices and Radiological Health (NCDRH). In addition to the draft recommendations, FDA is making available background information, rationale, and NCDRH's response to comments that were received on a notice of inquiry regarding the need for and content of such recommendations. FDA is also encouraging private groups and individuals to join in the research efforts needed to develop further technique/exposure guidance and suggests a number of principles to be followed in these efforts so all interested parties may achieve consistent and useful results. Final recommendations, when developed, will be published as a technical report in NCDRH's radiation recommendation series. PMID:10261489

  15. Slide-specific models for segmentation of differently stained digital histopathology whole slide images

    NASA Astrophysics Data System (ADS)

    Brieu, Nicolas; Pauly, Olivier; Zimmermann, Johannes; Binnig, Gerd; Schmidt, Günter

    2016-03-01

    The automatic analysis of whole slide images (WSIs) of stained histopathology tissue sections plays a crucial role in the discovery of predictive biomarkers in the field on immuno-oncology by enabling the quantification of the phenotypic information contained in the tissue sections. The automatic detection of cells and nuclei, while being one of the major steps of such analysis, remains a difficult problem because of the low visual differentiation of high pleomorphic and densely cluttered objects and of the diversity of tissue appearance between slides. The key idea of this work is to take advantage of well-differentiated objects in each slide to learn about the appearance of the tissue and in particular about the appearance of low-differentiated objects. We detect well-differentiated objects on a automatically selected set of representative regions, learn slide-specific visual context models, and finally use the resulting posterior maps to perform the final detection steps on the whole slide. The accuracy of the method is demonstrated against manual annotations on a set of differently stained images.

  16. Parametric Study of Dry Sliding Wear Behavior of Hybrid Metal Matrix Composite Produced by a Novel Process

    NASA Astrophysics Data System (ADS)

    Sharma, Pardeep; Sharma, Satpal; Khanduja, Dinesh

    2015-07-01

    In the present research work, silicon nitride (Si3N4) and graphite (Gr) ceramic powders are ball milled to obtain homogeneous mixing and consistent density of combined powder. The ball-milled powder is used as reinforcement for hybrid composite development by stir casting process in the inert atmosphere. After mixing by ball milling for 100 hours, the density of ball-milled (Si3N4 + Gr) powder is measured as 2.81 g/cm3, which is approximately equal to the density of aluminum (2.7 g/cm3). The microstructures and hardness of the manufactured hybrid composites are analyzed and compared with Si3N4- and Gr-reinforced composites. Scanning electron micrograph reveals a reasonably uniform dispersion of ball-milled (Si3N4 + Gr) reinforcement in the metal matrix composites. Hardness results reveal that hybrid composites have more hardness than Gr-reinforced and lower hardness than Si3N4-reinforced composites. The dry sliding wear behavior of aluminum matrix hybrid composites has also been investigated. Response surface methodology is used to develop wear model of hybrid composites using reinforcement percentage ( R), load ( L), sliding speed ( S), and sliding distance ( D) as the process parameters. The results of wear investigation show that increase in sliding speed ( S) and percentage reinforcement ( R) reduce the wear, while increase in sliding distance ( D) or load ( L) increases the wear of the hybrid composites. Further, the load-sliding distance and load-sliding speed interactions increase the wear, while the wear reduces due to sliding speed-sliding distance interaction in the high range. The errors between the modeled and experimental results are found within 3 to 7 pct.

  17. Career Approach to Media Development: Producing Slide and Slide-Tape Presentations. Career Education Monograph Series: Volume 1, Number 3.

    ERIC Educational Resources Information Center

    Silverman, Arnold

    The monograph is intended to demonstrate how the production of a slidetape show can become a multidisciplinary exercise that helps students become creative users of information, rather than passive receivers of information. Career education and audiovisual media instruction are both cross-disciplinary in nature and can be infused into existing…

  18. US FDA perspective on the regulations of medical-grade polymers: cyanoacrylate polymer medical device tissue adhesives.

    PubMed

    Mattamal, George J

    2008-01-01

    This article provides a brief description of the uses and clinical applications of medical-grade polymers, in particular synthetic cyanoacrylate adhesive/glue devices that have been cleared and/or approved as medical devices by the US FDA since the Medical Device Amendments of 1976 were enacted. This includes Class I cyanoacrylate devices (e.g., liquid bandages), Class II cyanoacrylate devices (e.g., dental cements), and Class III (premarket approval) cyanoacrylate devices such as Dermabond, Indermil Tissue Adhesive, Histoacryl and Histoacryl Blue Topical Skin Adhesive, and Trufill n-Butyl Cyanoacrylate Embolic Agent. By citing an example of FDA approved Class III devices in the cyanoacrylate technology, the article provides a brief discussion of the FDA approval process of medical devices. It includes the FDA issues regarding the published guidance document for 'Cyanoacrylate Topical Tissue Adhesives' that will provide guidance to regulatory personnel and manufacturers in the preparation of investigational device exception applications and in the development of valid scientific evidence to support premarket approval applications for cyanocrylate tissue adhesives intended for topical approximation of skin and others. The article provides a short regulatory description of the US FDA; under what laws its operates, how the FDA evaluates new devices for marketing, and how the device regulatory system works, for example, Class I, Class II, and Class III cyanoacrylate medical devices.

  19. Multi-mode sliding mode control for precision linear stage based on fixed or floating stator

    NASA Astrophysics Data System (ADS)

    Fang, Jiwen; Long, Zhili; Wang, Michael Yu; Zhang, Lufan; Dai, Xufei

    2016-02-01

    This paper presents the control performance of a linear motion stage driven by Voice Coil Motor (VCM). Unlike the conventional VCM, the stator of this VCM is regulated, which means it can be adjusted as a floating-stator or fixed-stator. A Multi-Mode Sliding Mode Control (MMSMC), including a conventional Sliding Mode Control (SMC) and an Integral Sliding Mode Control (ISMC), is designed to control the linear motion stage. The control is switched between SMC and IMSC based on the error threshold. To eliminate the chattering, a smooth function is adopted instead of a signum function. The experimental results with the floating stator show that the positioning accuracy and tracking performance of the linear motion stage are improved with the MMSMC approach.

  20. Non-linear adaptive sliding mode switching control with average dwell-time

    NASA Astrophysics Data System (ADS)

    Yu, Lei; Zhang, Maoqing; Fei, Shumin

    2013-03-01

    In this article, an adaptive integral sliding mode control scheme is addressed for switched non-linear systems in the presence of model uncertainties and external disturbances. The control law includes two parts: a slide mode controller for the reduced model of the plant and a compensation controller to deal with the non-linear systems with parameter uncertainties. The adaptive updated laws have been derived from the switched multiple Lyapunov function method, also an admissible switching signal with average dwell-time technique is given. The simplicity of the proposed control scheme facilitates its implementation and the overall control scheme guarantees the global asymptotic stability in the Lyapunov sense such that the sliding surface of the control system is well reached. Simulation results are presented to demonstrate the effectiveness and the feasibility of the proposed approach.