Science.gov

Sample records for fda presentation slides

  1. Slide Composition for Electronic Presentations

    ERIC Educational Resources Information Center

    Larson, Ronald B.

    2004-01-01

    Instructors who use computer-generated graphics in their lectures have many options to consider when developing their presentations. Experts give different advice on which typefaces, background and letter colors, and background imagery improve communications. This study attempted to resolve these controversies by examining how short-term recall of…

  2. An Easy Method for Preparing Presentation Slides.

    ERIC Educational Resources Information Center

    Wright, Norman A.; Blevins, Dennis D.

    1984-01-01

    Describes a simplified method of preparing 35mm projection slides with a minimum of equipment and expertise. The quality of these slides compares favorably to professionally produced diazo slides. Twenty-five slides can easily be prepared in less than three hours. Material cost per slide is comparable to professional color slide processing. (JN)

  3. Presentation video retrieval using automatically recovered slide and spoken text

    NASA Astrophysics Data System (ADS)

    Cooper, Matthew

    2013-03-01

    Video is becoming a prevalent medium for e-learning. Lecture videos contain text information in both the presentation slides and lecturer's speech. This paper examines the relative utility of automatically recovered text from these sources for lecture video retrieval. To extract the visual information, we automatically detect slides within the videos and apply optical character recognition to obtain their text. Automatic speech recognition is used similarly to extract spoken text from the recorded audio. We perform controlled experiments with manually created ground truth for both the slide and spoken text from more than 60 hours of lecture video. We compare the automatically extracted slide and spoken text in terms of accuracy relative to ground truth, overlap with one another, and utility for video retrieval. Results reveal that automatically recovered slide text and spoken text contain different content with varying error profiles. Experiments demonstrate that automatically extracted slide text enables higher precision video retrieval than automatically recovered spoken text.

  4. Alternative Films for Making Presentation Slides for the Occasional User.

    ERIC Educational Resources Information Center

    Hunt, Harold R., Jr.

    1985-01-01

    As alternatives to the well-known Kodak Kodalith film for making presentation slides, suggests using Kodak Technical Pan Film, 2415 and Kodak Precision Fine Film LPD4. Although less known, both films are capable of making excellent quality slides with minimum effort and, for the occasional user, offer advantages over the Kodalith-Diazochrome…

  5. Environmental radiation standards. [Outline of slide presentation

    SciTech Connect

    Kocher, D.C.

    1987-01-01

    This document contains an outline of an oral presentation on environmental radiation standards presented to the American Nuclear Societies' Topical Conference on Population Exposure from the Nuclear Fuel Cycle. The paper contains several definitions, a summary of current radiation exposure limits; and numerous proposed changes to current standards. 7 figs. (TEM)

  6. 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…

  7. The Environmental Obligations of Experiential Education: A Slide Presentation [Script].

    ERIC Educational Resources Information Center

    Nadeau, Tina

    The slide presentation script is intended to familiarize environmental educators with the "Whole Life Factor," an educational tool developed by the National Audubon Society Expedition Institute. The script first explores cultural images of nature and prejudice against nature. The theory that civilization perceives the planet as divided into…

  8. Incorporating Concept Maps in a Slide Presentation Tool for the Classroom Environment.

    ERIC Educational Resources Information Center

    Gopal, Kreshna; Morapakkam, Karthik

    This paper presents a slide presentation software that incorporates a concept map, which explicitly shows how the various slides (and other multimedia components) presented are related to each other. Furthermore, presentations are conceived as hypermedia systems, where the presenter can navigate among slides (and the concept map) instead of the…

  9. 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

  10. 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…

  11. Presentable Slides: A Practical Approach for Amateur Draftsmen.

    ERIC Educational Resources Information Center

    Seel, D. C.

    1984-01-01

    To contribute usefully to a lecture, slides containing tabulated or diagrammatic textual information need to be simple and legible. Such slides can be made by following a few straightforward rules and techniques. Several of these rules and techniques are provided. (JN)

  12. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Drugs@FDA: FDA Approved Drug Products FDA Home Drug Databases Drugs@FDA - FAQ | Instructions | ... 6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency ...

  13. SLIDE PRESENTATION: LIMITATIONS OF USE OF GEOSYNTHETIC CLAY LINERS (GCLS)

    EPA Science Inventory

    This presentation describes the design and construction issues pertaining to the use of geosynthetic clay liners (GCLSs) in waste containment. The presentation covers new materials, potential design and construction pitfalls and a summary of ongoing research.

  14. 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.

  15. 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…

  16. Integrating Annotations into a Dual-Slide PowerPoint Presentation for Classroom Learning

    ERIC Educational Resources Information Center

    Lai, Yen-Shou; Tsai, Hung-Hsu; Yu, Pao-Ta

    2011-01-01

    This study introduces a learning environment integrating annotations with a dual-slide PowerPoint presentation for classroom learning. Annotation means a kind of additional information to emphasize the explanations for the learning objects. The use of annotations is to support the cognitive process for PowerPoint presentation in a classroom. The…

  17. Survey of the Use of Slide/Tape Presentations for Orientation and Instruction Purposes in Academic Libraries.

    ERIC Educational Resources Information Center

    Hardesty, Larry

    Eighty-eight academic libraries were surveyed to determine what kinds of slide/tape library instruction materials are available for purchase or loan. The conclusions reached were: (1) there are less than a dozen libraries that have produced presentations of sufficient quality and adaptability to be widely used; and (2) the slide/tape format…

  18. Digital slides: present status of a tool for consultation, teaching, and quality control in pathology.

    PubMed

    Rocha, Rafael; Vassallo, José; Soares, Fernando; Miller, Keith; Gobbi, Helenice

    2009-01-01

    In the last few years, telepathology has benefited from the progress in the technology of image digitalization and transmission through the world web. The applications of telepathology and virtual imaging are more current in research and morphology teaching. In surgical pathology daily practice, this technology still has limits and is more often used for case consultation. In the present review, we intend to discuss its applications and challenges for pathologists and scientists. Much of the limitations of virtual imaging for the surgical pathologist reside in the capacity of storage of images, which so far has hindered the more widespread use of this technology. Overcoming this major drawback may revolutionize the surgical pathologist's activity and slide storing. PMID:19501988

  19. 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…

  20. Slide-tape versus lecture demonstration presentation of thermal agents in a physical therapist assistant program.

    PubMed

    Asklund, S; Brown, S; Fiterman, C

    1976-12-01

    A slide-tape individualized method and a conventional lecture-demonstration method of teaching thermal agents to physical therapist assistant students were compared. Performance measures included clinical procedures, written tests, attitudes toward the method used, and time spent in the learning center and in the classroom laboratory. No significant differences were found between the groups on performance of clinical procedures, written tests, or attitudes. The group using the slide-tape individualized method, however, spent significantly less time in achieving satisfactory performance on written tests and in clinical procedures. PMID:63129

  1. 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 ...

  2. FDA Certified Mammography Facilities

    MedlinePlus

    ... Products Radiation-Emitting Products Home Radiation-Emitting Products Mammography Quality Standards Act and Program Consumer Information (MQSA) ... it Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on ...

  3. 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 ...

  4. 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.

  5. 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.

  6. 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…

  7. 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. PMID:26027494

  8. 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…

  9. Handbuilt Slides.

    ERIC Educational Resources Information Center

    Gatto, Joseph

    1979-01-01

    The author suggests handbuilt slides as an art project for elementary or secondary students. Instructions are given for making slides with found objects, smoke, and magazine lifts. The article is illustrated with several examples of this technique. (SJL)

  10. 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 ...

  11. Genotyping of Mycobacterium leprae present on Ziehl-Neelsen-stained microscopic slides and in skin biopsy samples from leprosy patients in different geographic regions of Brazil.

    PubMed

    Fontes, Amanda Nogueira Brum; Gomes, Harrison Magdinier; Araujo, Marcelo Ivens de; Albuquerque, Edson Cláudio Araripe de; Baptista, Ida Maria Foschiani Dias; Moura, Maria Manuela da Fonseca; Rezende, Denise Silva; Pessolani, Maria Cristina Vidal; Lara, Flávio Alves; Pontes, Maria Araci de Andrade; Gonçalves, Heitor de Sá; Lucena-Silva, Norma; Sarno, Euzenir Nunes; Vissa, Varalakshmi D; Brennan, Patrick J; Suffys, Philip Noel

    2012-12-01

    We analysed 16 variable number tandem repeats (VNTR) and three single-nucleotide polymorphisms (SNP) in Mycobacterium leprae present on 115 Ziehl-Neelsen (Z-N)-stained slides and in 51 skin biopsy samples derived from leprosy patients from Ceará (n = 23), Pernambuco (n = 41), Rio de Janeiro (n = 22) and Rondônia (RO) (n = 78). All skin biopsies yielded SNP-based genotypes, while 48 of the samples (94.1%) yielded complete VNTR genotypes. We evaluated two procedures for extracting M. leprae DNA from Z-N-stained slides: the first including Chelex and the other combining proteinase and sodium dodecyl sulfate. Of the 76 samples processed using the first procedure, 30.2% were positive for 16 or 15 VNTRs, whereas of the 39 samples processed using the second procedure, 28.2% yielded genotypes defined by at least 10 VNTRs. Combined VNTR and SNP analysis revealed large variability in genotypes, but a high prevalence of SNP genotype 4 in the Northeast Region of Brazil. Our observation of two samples from RO with an identical genotype and seven groups with similar genotypes, including four derived from residents of the same state or region, suggest a tendency to form groups according to the origin of the isolates. This study demonstrates the existence of geographically related M. leprae genotypes and that Z-N-stained slides are an alternative source for M. leprae genotyping. PMID:23283465

  12. 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.

  13. Slide Classification and Cataloging.

    ERIC Educational Resources Information Center

    Clawson, Catherine R.; Ronkowski, Charles A.

    1981-01-01

    Follows up an August 1978 article on the cataloging of slides using color photocopying, and presents unsolicited reactions to that article from librarians who were interested in the slide system developed for use in the C-E Refractories Research and Development Library. Twelve references are listed. (FM)

  14. UNDERSTANDING THE SLIDE RULE.

    ERIC Educational Resources Information Center

    JOHNSON, RONALD E.; AND OTHERS

    A BOOKLET DESIGNED FOR ELEMENTARY SCHOOL STUDENTS TO BE USED INDEPENDENTLY FROM AND IN ADDITION TO THE REGULAR CLASSROOM CURRICULUM IN MATHEMATICS IS GIVEN. THE FIFTH- OR SIXTH-GRADE STUDENT IS PRESENTED WITH A DISCUSSION OF THE APPLICATIONS OF THE SLIDE RULE AND WITH A BACKGROUND REVIEW OF NECESSARY CONCEPTS. THE CONCEPTS OF THE SLIDE RULE ARE…

  15. FDA-Approved Biosimilar Insulin

    PubMed Central

    2014-01-01

    If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient’s home. Adulterated products could be considered “counterfeit” since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes. PMID:25172881

  16. 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

  17. FDA regulation of tobacco: blessing or curse for FDA professionals?

    PubMed

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields. PMID:19999639

  18. 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…

  19. Design for slides.

    PubMed

    Johns, M

    1995-09-01

    The basic principles of design for projection slides are discussed, with particular reference to the impact of the personal computer and commercial presentation software on the material that is destined to end up on the screen at meetings and in seminar rooms. While modern software can be a boon to the presenter, allowing simple creation of slides, it can also encourage some of the worst excesses. The keynote of the design of slides for educational purposes should be simplicity, and ways of achieving simple but effective results are described. PMID:8550965

  20. 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.

  1. 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.

  2. 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 ...

  3. 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 ...

  4. 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. PMID:11381856

  5. 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)

  6. 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

    ...In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing......

  7. 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

  8. Alternative Learning Community Slide Presentation.

    ERIC Educational Resources Information Center

    1975

    What do you do with a destructive student within the traditional framework who is threatened with expulsion? How about the conflicted student with personal and family problems who cannot tolerate a large classroom situation? Is there a place for the pregnant married or unmarried youngster who is too embarrassed to face her classmates? Do you…

  9. Appearance Normalization of Histology Slides

    PubMed Central

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

    2011-01-01

    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 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. PMID:25360444

  10. Pharmaceutical trademarks: navigating through the FDA's pilot program.

    PubMed

    Ferrer, Elisa

    2010-06-01

    Creation and clearance of pharmaceutical trademarks continues to be one of the most difficult and challenging areas of trademark law. The Food and Drug Administration (FDA) recently initiated a 2-year Pilot Program under Prescription Drug User Fee Act (PDUFA) IV. The intent of the program is to enable participating pharmaceutical firms to evaluate proposed pharmaceutical marks and submit the data generated from those evaluations to the FDA for review. Submitting a trademark to the FDA warrants questions: What supporting data is needed and accepted when proposing a mark? What issues might arise, and how can they be averted? In a recent Thomson Reuters on-demand webinar (http://science.thomsonreuters.com/news/2010-02/8580404/), a group of renowned experts in the field of trademark development review the FDA pilot program, outline the requirements for submission and discuss what the changes will mean in clearing new pharmaceutical marks. They also present various approaches to trademark development and evaluation in light of the FDA's views. PMID:20603657

  11. 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…

  12. The FDA and designing clinical trials for chronic cutaneous ulcers.

    PubMed

    Maderal, Andrea D; Vivas, Alejandra C; Eaglstein, William H; Kirsner, Robert S

    2012-12-01

    Treatment of chronic wounds can present a challenge, with many patients remaining refractory to available advanced therapies. As such, there is a strong need for the development of new products. Unfortunately, despite this demand, few new wound-related drugs have been approved over the past decade. This is in part due to unsuccessful clinical trials and subsequent lack of Food and Drug Administration (FDA) approval. In this article, we discuss the FDA approval process, how it relates to chronic wound trials, common issues that arise, and how best to manage them. Additionally, problems encountered specific to diabetic foot ulcers (DFU) and venous leg ulcers (VLU) are addressed. Careful construction of a clinical trial is necessary in order to achieve the best possible efficacy outcomes and thereby, gain FDA approval. How to design an optimal trial is outlined. PMID:23063664

  13. 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. PMID:25863518

  14. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... gov/medlineplus/news/fullstory_159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing ... 26, 2016 (HealthDay News) -- A new long-acting implant that can help treat people addicted to heroin ...

  15. FDA Approves Eye Implant for Aging Boomers

    MedlinePlus

    ... medlineplus/news/fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to ... 2016 THURSDAY, June 30, 2016 (HealthDay News) -- An implant that helps the aging eye focus on small ...

  16. 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 ...

  17. 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 ...

  18. 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®)

  19. FDA Launches Ad Campaign Against Chewing Tobacco

    MedlinePlus

    ... 158385.html FDA Launches Ad Campaign Against Chewing Tobacco Health officials targeting rural teens with messages about health risks of smokeless tobacco products To use the sharing features on this ...

  20. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... 159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing eliminates need to take ... U.S. Food and Drug Administration. "Opioid abuse and addiction have taken a devastating toll on American families. ...

  1. FDA Approves First Fully Dissolvable Stent

    MedlinePlus

    ... fullstory_159721.html FDA Approves First Fully Dissolvable Stent Device is absorbed by the body after about ... July 5, 2016 (HealthDay News) -- The first coronary stent to be gradually absorbed by the body has ...

  2. FDA Bolsters Warnings about Class of Antibiotics

    MedlinePlus

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

  3. 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 ...

  4. CI Slide: calibration slide for quantitative microscopy imaging in absorbance

    NASA Astrophysics Data System (ADS)

    Sheikhzadeh, Fahime; Ye, Qian; Zulkafly, Nasir; Carraro, Anita; Korbelic, Jagoda; Chen, Zhaoyang; Harrison, Alan; Follen, Michele; MacAulay, Calum; Ward, Rabab K.; Guillaud, Martial

    2014-03-01

    New imaging technologies are changing the field of digital pathology. This field faces numerous challenges and there is a pressing need for standardization, calibration protocols, quality control and quantitative assessment. We have designed a new calibration imaging slide (Cancer Imaging Slide), specifically to measure the characteristics of old or new imaging systems or scanners. The layout of the slide consists of 138 boxes with the side length of 1.6 mm, containing objects of known morphologic and photometric characteristics. Among them, 112 boxes contain different permutations of circles, ovals, and squares. The circles have different radii, radius/pitch ratios and step transmissions. The ovals have different sizes and orientations. The squares are consistent in size and orientation but have different step transmission values. Also, 16 boxes contain three resolution test targets: crosses, USAF target and Siemens star. The last 10 boxes are blank boxes with different transmission values. Four slides were scanned and imaged on one commercial whole-slide scanner and one high resolution imaging system. After segmenting the images, about 200 features (photometric, morphologic and architectural) were measured with our in-house image processing software. The objective of the project is to develop a statistical process control using this new slide. In this paper, we describe the characteristics of the slide and present our preliminary results.

  5. 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.

  6. Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?

    PubMed

    Kelley, Peter

    2010-01-01

    It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

  7. 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

  8. 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®)

  9. FDA panel finds mifepristone safe and effective.

    PubMed

    1996-07-26

    At a July 19 hearing, the Food and Drug Administration's Advisory Committee for Reproductive Health Drugs found mifepristone to be safe and effective in inducing abortions early in pregnancy and recommended that the drug be approved for marketing in the US. With a 6-0 vote with two abstentions, the eight-member panel found that mifepristone's benefits were greater than its risks; agreed, 7-0, with one abstention, that it is safe; voted 6-2 to accept data from a French study as sufficient to recommend use in this country; and decided unanimously to reconvene if results from US clinical trials differ significantly from those from France. While the FDA is not required to follow the panel's advice, it is highly uncommon for it to do otherwise. The advisory panel scheduled the hearing in response to an application filed this spring by the Population Council, the nonprofit organization that owns the US patent rights to the drug. The meeting began with a presentation by the Population Council on the results of an American mifepristone trial that involved more than 2000 women and a discussion of the data from studies and practical use in France. The second session brought public testimony from 33 speakers, the majority of whom spoke in favor of the drug's approval. A company plans to manufacture mifepristone once it is approved but refuses to reveal its identity out of concern that it will be a target for anti-choice protests and boycotts. The drug would be marketed by Advances in Health Technology, Inc., an enterprise designated by the Population Council as the exclusive US distributor of mifepristone--the abortifacient marketed as RU486 in France and used by nearly 200,000 women in Europe and elsewhere. PMID:12347288

  10. 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.

  11. 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...

  12. Secondary Reverse Slide Tracheoplasty for Airway Rescue.

    PubMed

    Kopelovich, Jonathan C; Wine, Todd M; Rutter, Michael J; Mitchell, Max B; Prager, Jeremy D

    2016-03-01

    Slide tracheoplasty is used in cases of tracheal stenosis or injury. With expanding indications for its use at tertiary centers, salvage techniques for dehiscence or restenosis after slide tracheoplasty are increasingly relevant. We present a case in which slide tracheoplasty was augmented with an anterior costochondral graft that stenosed again and ultimately failed. We salvaged this airway emergency by performing a secondary reverse slide tracheoplasty. Using this technique, we were able to establish a safe and durable airway using only native airway tissue. PMID:26897214

  13. 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

  14. 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 ...

  15. FDA Modernizes Nutrition Facts Label for Packaged Foods

    MedlinePlus

    ... Department of Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health ... Release FDA modernizes Nutrition Facts label for packaged foods Refreshed design and relevant information will help consumers ...

  16. 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

  17. 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 RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives...

  18. 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... 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...

  19. 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...

  20. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... In the February 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing... disclosure. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR...

  1. Transparent acrylic enamel slide holograms

    NASA Astrophysics Data System (ADS)

    Ponce-Lee, E. L.; Olivares Pérez, A.; Ruiz-Limón, B.; Hernández-Garay, M. P.; Toxqui-López, S.

    2006-02-01

    We present holograms generated in a computer to an acrylic enamel slide (Comex (R)), getting phase holograms. The information in the mask is transferred to the material by temperature gradients generated by rubbing. The refraction index is transformed at each material point by the temperature changes, thus the film is recorded and developed by itself. this material can be used for soft lithography.

  2. Flexible sliding seal

    NASA Technical Reports Server (NTRS)

    Wallenhorst, E. L.

    1980-01-01

    Circular seal both slides and flexes to accomodate relative motion between two sealed members. Originally developed for Space Shuttle orbiter, it contains sliding seal to accommodate engine gimbaling and flexible seal that absorbs forward motion at high thrust of engine heat shield relative to airframe. Other possible applications are in support structures of heavy machinery and vehicle engines. Flexible sliding seal is ring about 7 feet in diameter and can withstand temperatures up to 1,600 F.

  3. Herbaceous Ornamental Plants. 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 commercially important herbaceous ornamental plants. Included in the script are narrations for use with a total of 338 slides illustrating 150 different plants. Generally, two slides are used to illustrate each plant: one slide shows…

  4. Classification and Cataloging of Slides Using Color Photocopying

    ERIC Educational Resources Information Center

    Clawson, Catherine R.; Rankowski, Charles A.

    1978-01-01

    The classification and cataloging of slides pose unique and critical problems in every field where they are used. A brief overview of the literature is presented, along with observations on local area slide systems and a description of a slide system developed for use in C-E Refractories' Research and Development Library utilizing color…

  5. Slides and the Foreign Language Teacher: A Bibliography.

    ERIC Educational Resources Information Center

    Galt, Alan

    This bibliography lists 275 items relating to the use of visual and audiovisual aids in the foreign language classroom. The items are entered under the following major headings: (1) Audiovisual Aids; (2) Photography; (3) Picture Composition; (4) Slides and Photographs for Teaching; and (5) Slides and Slide Shows: Production and Presentation.…

  6. 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. PMID:26048277

  7. 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.

  8. 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...

  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. 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

  12. 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

  13. 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

  14. Target selection for FDA-approved medicines.

    PubMed

    Kinch, Michael S; Hoyer, Denton; Patridge, Eric; Plummer, Mark

    2015-07-01

    The biopharmaceutical industry translates fundamental understanding of disease into new medicines. As part of a comprehensive analysis of FDA-approved new molecular entities (NMEs), we assessed the mechanistic basis of drug efficacy, with emphasis on target selection. Three target families capture almost half of all NMEs and the leading ten families capture more than three-quarters of NME approvals. Target families were related to their clinical application and identify dynamic trends in targeting over time. These data suggest increasing attention toward novel target families, which presumably reflects increased understanding of disease etiology. We also suggest the need to balance the ongoing emphasis on target-based drug discovery with phenotypic approaches to drug discovery. PMID:25462532

  15. 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

  16. 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)

  17. 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.

  18. 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…

  19. 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…

  20. 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…

  1. Semantic Focusing Allows Fully Automated Single-Layer Slide Scanning of Cervical Cytology Slides

    PubMed Central

    Lahrmann, Bernd; Valous, Nektarios A.; Eisenmann, Urs; Wentzensen, Nicolas; Grabe, Niels

    2013-01-01

    Liquid-based cytology (LBC) in conjunction with Whole-Slide Imaging (WSI) enables the objective and sensitive and quantitative evaluation of biomarkers in cytology. However, the complex three-dimensional distribution of cells on LBC slides requires manual focusing, long scanning-times, and multi-layer scanning. Here, we present a solution that overcomes these limitations in two steps: first, we make sure that focus points are only set on cells. Secondly, we check the total slide focus quality. From a first analysis we detected that superficial dust can be separated from the cell layer (thin layer of cells on the glass slide) itself. Then we analyzed 2,295 individual focus points from 51 LBC slides stained for p16 and Ki67. Using the number of edges in a focus point image, specific color values and size-inclusion filters, focus points detecting cells could be distinguished from focus points on artifacts (accuracy 98.6%). Sharpness as total focus quality of a virtual LBC slide is computed from 5 sharpness features. We trained a multi-parameter SVM classifier on 1,600 images. On an independent validation set of 3,232 cell images we achieved an accuracy of 94.8% for classifying images as focused. Our results show that single-layer scanning of LBC slides is possible and how it can be achieved. We assembled focus point analysis and sharpness classification into a fully automatic, iterative workflow, free of user intervention, which performs repetitive slide scanning as necessary. On 400 LBC slides we achieved a scanning-time of 13.9±10.1 min with 29.1±15.5 focus points. In summary, the integration of semantic focus information into whole-slide imaging allows automatic high-quality imaging of LBC slides and subsequent biomarker analysis. PMID:23585899

  2. Preparing Scientific Papers, Posters, and Slides.

    PubMed

    Lefor, Alan Kawarai; Maeno, Misato

    2016-01-01

    Publications and presentations are important in academic medicine. The ability to present information in a standard fashion is critically important. Papers, posters, and slides must be prepared appropriately to maximize their chance of being accepted. The first step is to use word processing software correctly. English language usage must conform to standard scientific English usage. Abbreviations should be avoided as much as possible. Numerical data must be presented with the appropriate number of significant figures. The first step in preparing a paper is to decide the target journal. Papers should always be written in 12 point Times New Roman font, while slides and posters should be in Arial or Helvetica. The Results section must contain actual data with appropriate statistical analysis. Take great care to prepare figures and tables according to the journal's instructions. Posters must be prepared to allow easy reading at a distance of 2m. Use a white background and dark letters. The majority of the area of your poster should be Results, and there is no need to include the abstract or references on a poster. Slide presentations should be limited to about one slide for each minute of the talk. Avoid the use of animations and excessive use of color. Do not use abbreviations on slides. Following these simple guidelines will meet the requirements of most journals and allow your audience to appreciate the data on your posters and slides. PMID:26572095

  3. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational... the device as a factor in making Medicare coverage decisions. ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices....

  4. 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...

  5. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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... application needed to facilitate the agency's review. This early communication is intended to...

  6. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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... process. Such communication may take the form of telephone conversations, letters, or meetings,...

  7. Autologous cell therapies: challenges in US FDA regulation.

    PubMed

    McAllister, Todd N; Audley, David; L'Heureux, Nicolas

    2012-11-01

    Cell-based therapies (CBTs) have been hailed for the last two decades as the next pillar of healthcare, yet the clinical and commercial potential of regenerative medicine has yet to live up to the hype. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. With 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, one must contemplate why CBTs have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. Here, we highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous CBTs. PMID:23210819

  8. 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.

  9. A Sliding Mode Controller Using Nonlinear Sliding Surface Improved With Fuzzy Logic: Application to the Coupled Tanks System

    NASA Astrophysics Data System (ADS)

    Boubakir, A.; Boudjema, F.; Boubakir, C.

    2008-06-01

    This paper proposes an approach of hybrid control that is based on the concept of combining fuzzy logic and the methodology of sliding mode control (SMC). In the present works, a first-order nonlinear sliding surface is presented, on which the developed control law is based. Mathematical proof for the stability and convergence of the system is presented. In order to reduce the chattering in sliding mode control, a fixed boundary layer around the switch surface is used. Within the boundary layer, since the fuzzy logic control is applied, the chattering phenomenon, which is inherent in a sliding mode control, is avoided by smoothing the switch signal. Outside the boundary, the sliding mode control is applied to driving the system states into the boundary layer. Experimental studies carried out on a coupled Tanks system indicate that the proposed fuzzy sliding mode control (FSMC) is a good candidate for control applications.

  10. 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…

  11. 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…

  12. 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 ...

  13. FDA Approves Experimental Zika Test for Blood Donations

    MedlinePlus

    ... html FDA Approves Experimental Zika Test for Blood Donations But agency still asks those who've possibly ... HealthDay News) -- An experimental test to check blood donations for the Zika virus has been approved by ...

  14. 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 ...

  15. Expediting drug development--the FDA's new "breakthrough therapy" designation.

    PubMed

    Sherman, Rachel E; Li, Jun; Shapley, Stephanie; Robb, Melissa; Woodcock, Janet

    2013-11-14

    The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies. PMID:24224621

  16. FDA Calls for Less Salt in Processed Foods

    MedlinePlus

    ... news/fullstory_159136.html FDA Calls for Less Salt in Processed Foods Agency sets short- and long- ... the food industry to cut back on the salt. In draft voluntary guidelines issued Wednesday, the agency ...

  17. 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).

  18. 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 ...

  19. Drug for Yeast Infections May Raise Miscarriage Risk, FDA Warns

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158503.html Drug for Yeast Infections May Raise Miscarriage Risk, FDA Warns Agency recommends ... brand name Diflucan) is used to treat vaginal yeast infections. "Patients who are pregnant or actively trying to ...

  20. FDA Approves New Drug to Treat Bladder Cancer

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158937.html FDA Approves New Drug to Treat Bladder Cancer Tecentriq boosted survival ... 2016 THURSDAY, May 19, 2016 (HealthDay News) -- A new drug to treat bladder cancer was approved by ...

  1. 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 ...

  2. FDA to Re-Examine What Makes a Food 'Healthy'

    MedlinePlus

    ... should be labeled "healthy"? Raisin bran? Avocados? Granola bars? Going by current -- and perhaps outdated -- U.S. food- ... healthy" is Kind LLC, a producer of granola bars, which was warned by the FDA last year ...

  3. FDA Calls for Less Salt in Processed Foods

    MedlinePlus

    ... html FDA Calls for Less Salt in Processed Foods Agency sets short- and long-term goals in ... WEDNESDAY, June 1, 2016 (HealthDay News) -- The U.S. Food and Drug Administration wants the food industry to ...

  4. 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.

  5. Leavitt: reforms will improve oversight and openness at FDA.

    PubMed

    2005-01-01

    Health and Human Services Secretary Mike Leavitt says drug safety reforms at the Food and Drug Administration will improve openness and oversight and will enhance the agency's independence. In keeping with this vision, the FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues and will provide emerging information to doctors and patients about the risks and benefits of medicines. For more information www.fda.gov/cder/drugsafety.htm PMID:16127819

  6. FDA's regulation of tanning beds: how much heat?

    PubMed

    Knapp, Veronica

    2011-01-01

    This paper considers the problem of indoor tanning bed use by teenagers. The paper explores FDA's current authority to regulate tanning lamps as Class I medical devices, concluding that FDA's authority is poorly tailored to affect teenagers' repeated use of these products. An outright ban is unlikely; therefore, the best available options are to regulate access by minors and to amend the warning label requirements to reflect the current state of knowledge about the risks of tanning bed use. PMID:24505845

  7. Computer Slide Shows: A Trap for Bad Teaching

    ERIC Educational Resources Information Center

    Klemm, W. R.

    2007-01-01

    Slide shows presented with software such as PowerPoint or WordPerfect Presentations can trap instructors into bad teaching practices. Research on memory suggests that slide-show instruction can actually be less effective than traditional lecturing when the teacher uses a blackboard or overhead projector. The author proposes a model of classroom…

  8. FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

    PubMed

    Drum, Bruce

    2004-01-01

    The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device. PMID:15518230

  9. Slide identification for lecture movies by matching characters and images

    NASA Astrophysics Data System (ADS)

    Ozawa, Noriaki; Takebe, Hiroaki; Katsuyama, Yutaka; Naoi, Satoshi; Yokota, Haruo

    2003-12-01

    Slide identification is very important when creating e-Learning materials as it detects slides being changed during lecture movies. Simply detecting the change would not be enough for e-Learning purposes. Because, which slide is now displayed in the frame is also important for creating e-Learning materials. A matching technique combined with a presentation file containing answer information is very useful in identifying slides in a movie frame. We propose two methods for slide identification in this paper. The first is character-based, which uses the relationship between the character code and its coordinates. The other is image-based, which uses normalized correlation and dynamic programming. We used actual movies to evaluate the performance of these methods, both independently and in combination, and the experimental results revealed that they are very effective in identifying slides in lecture movies.

  10. 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.

  11. 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. PMID:23260528

  12. 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.

  13. 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.

  14. 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

  15. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    PubMed

    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

  16. 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

  17. FDA perspectives on health claims for food labels.

    PubMed

    Rowlands, J Craig; Hoadley, James E

    2006-04-01

    The U.S. Food and Drug Administration's regulatory authority over health claims was clarified in 1990 legislation known as the Nutrition Labeling and Education Act (NLEA). This law established mandatory nutrition labeling for most foods and placed restrictions on the use of food label claims characterizing the levels or health benefits of nutrients in foods. NLEA set a high threshold for the scientific standard under which the U.S. Food and Drug Administration (FDA) may authorize health claims, this standard is known as the significant scientific agreement (SSA) standard. Subsequent legislation known as the Food and Drug Administration Modernization Act (FDAMA) provided an alternative to FDA review of the health claim where an U.S. government scientific body other than FDA concluded that there is SSA for a substance/disease relationship. Courts have since extended the scope of health claims to include qualified health claims (QHC) that are health claims not substantiated on evidence that meets the level of SSA standard, but include a qualifying statement intended to convey to the consumer the level of evidence for the claim. FDA has responded by developing an evidence-based ranking system for scientific data to determine the level of evidence substantiating a health claim. The following is an overview of FDA's regulations and evidence-based method for evaluating health claims. PMID:16480811

  18. 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

  19. 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)

  20. 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.

  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. 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.

  3. 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.

  4. 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

  5. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA- 2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III--A...

  6. Characteristics of Pivotal Trials and FDA Review of Innovative Devices

    PubMed Central

    Rising, Joshua P.; Moscovitch, Ben

    2015-01-01

    When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies—and contributing factors, such as primary outcome measures and enrollment—could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues. PMID:25651420

  7. [Development of an obstetrical pocket slide rule].

    PubMed

    Krüger, G

    1986-01-01

    We present a slide rule to value old obstetric and ultrasound findings in prenatal care day by day. We have developed the scale. Manufacturer is VEB Mantissa Dresden, sales department is Staatliches Versorgungskontor für Pharmazie und Medizintechnik. PMID:3727852

  8. A tale of two transparency attempts at FDA.

    PubMed

    Tai, Laurence

    2013-01-01

    This Article describes and evaluates two elements of the FDA's recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency's FOIA backlog. After discussing the legal context for information disclosure at the FDA and these two transparency attempts, this Article identifies two reasons that the first has fallen short of expectations compared to the second: unlike the reduction in the FOIA backlog, the Transparency Initiative had legal constraints that it did not adequately address, along with political appointee leadership. These principles may be more generally useful for understanding how to stimulate institutional change in administrative agencies. PMID:24552081

  9. 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.

  10. The big problem of the missing cytology slides

    PubMed Central

    Gatter, Ken M

    2004-01-01

    Cytology slides are often unique and irreplaceable. Unlike surgical pathology cases, where additional paraffin sections can be cut, cytology slides often cannot be duplicated because there are only a few direct smears or the diagnostic material is present on a single slide. Cytology slides are often "sent out" to other physicians, laboratories or hospitals, typically so that the pathologist at the institution where the patient will receive treatment can review the slides. Less often, a cytology lab sends out the slides for a second opinion or as part of the discovery process in a lawsuit, where they may or may not be defendants. Rarely, unique and irreplaceable cytology slides are lost. This article presents a hypothetical scenario that is based on reported state appellate court decisions. The article discusses some of the legal issues that will affect the defendant cytologist/cytology lab and the "expert cytologist," and suggests some steps a cytologist/cytology lab can take to minimize the risk of repercussions from a lost unique and irreplaceable cytology slide. PMID:15500703

  11. Screening and dotting virtual slides: A new challenge for cytotechnologists.

    PubMed

    Khalbuss, Walid E; Cuda, Jackie; Cucoranu, Ioan C

    2013-01-01

    Digital images are increasingly being used in cytopathology. Whole-slide imaging (WSI) is a digital imaging modality that uses computerized technology to scan and convert entire cytology glass slides into digital images that can be viewed on a digital display using the image viewer software. Digital image acquisition of cytology glass slides has improved significantly over the years due to the use of liquid-based preparations and advances in WSI scanning technology such as automatic multipoint pre-scan focus technology or z-stack scanning technology. Screening cytotechnologists are responsible for every cell that is present on an imaged slide. One of the challenges users have to overcome is to establish a technique to review systematically the entire imaged slide and to dot selected abnormal or significant findings. The scope of this article is to review the current user interface technology available for virtual slide navigation when screening digital slides in cytology. WSI scanner vendors provide tools, built into the image viewer software that allow for a more systematic navigation of the virtual slides, such as auto-panning, keyboard-controlled slide navigation and track map. Annotation tools can improve communication between the screener and the final reviewer or can be used for education. The tracking functionality allows recording of the WSI navigation process and provides a mechanism for confirmation of slide coverage by the screening cytotechnologist as well as a useful tool for quality assurance. As the WSI technology matures, additional features and tools to support navigation of a cytology virtual slide are anticipated. PMID:24379891

  12. Screening and dotting virtual slides: A new challenge for cytotechnologists

    PubMed Central

    Khalbuss, Walid E.; Cuda, Jackie; Cucoranu, Ioan C.

    2013-01-01

    Digital images are increasingly being used in cytopathology. Whole-slide imaging (WSI) is a digital imaging modality that uses computerized technology to scan and convert entire cytology glass slides into digital images that can be viewed on a digital display using the image viewer software. Digital image acquisition of cytology glass slides has improved significantly over the years due to the use of liquid-based preparations and advances in WSI scanning technology such as automatic multipoint pre-scan focus technology or z-stack scanning technology. Screening cytotechnologists are responsible for every cell that is present on an imaged slide. One of the challenges users have to overcome is to establish a technique to review systematically the entire imaged slide and to dot selected abnormal or significant findings. The scope of this article is to review the current user interface technology available for virtual slide navigation when screening digital slides in cytology. WSI scanner vendors provide tools, built into the image viewer software that allow for a more systematic navigation of the virtual slides, such as auto-panning, keyboard-controlled slide navigation and track map. Annotation tools can improve communication between the screener and the final reviewer or can be used for education. The tracking functionality allows recording of the WSI navigation process and provides a mechanism for confirmation of slide coverage by the screening cytotechnologist as well as a useful tool for quality assurance. As the WSI technology matures, additional features and tools to support navigation of a cytology virtual slide are anticipated. PMID:24379891

  13. Interactive perspective: drug development and FDA approval, 1938-2013.

    PubMed

    2015-02-01

    Interactive Perspective: Drug Development and FDA Approval, 1938-2013 (June 26, 2014;370:e39). The order of authors was incorrect; Dr. Darrow should have been listed first, and Dr. Kesselheim second. The article is correct at NEJM.org. PMID:25651270

  14. 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...

  15. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 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...

  16. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... resources. Information on FDA closures and restrictions will be available for inspection at the park visitor... 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... resources. Information on FDA closures and restrictions will be available for inspection at the park visitor... 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. FDA OKs New Injectable Type 2 Diabetes Medication

    MedlinePlus

    ... shouldn't be used to treat people with type 1 diabetes. It also shouldn't be used by anyone with increased ketones (a sign that the body isn't getting enough insulin) in their blood or urine, or extremely elevated ketones (diabetic ketoacidosis), the FDA said. Common side effects of ...

  19. FDA post-approval expectations for adventitious virus contamination prevention.

    PubMed

    Friedman, Richard L

    2011-01-01

    CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA). PMID:22294604

  20. 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...

  1. 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...

  2. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:...

  3. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:...

  4. FDA Boxed Warning for Immediate-Release Opioids.

    PubMed

    Food And Drug Administration Public Health Service U S Department Of Health And Human Services

    2016-06-01

    On March 22, 2016, the Food and Drug Administration (FDA) announced enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death. The new safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use. PMID:27301692

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 316.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (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...

  10. 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…

  11. 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. PMID:26752020

  12. 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.

  13. Solar-Cell Slide Rule

    NASA Technical Reports Server (NTRS)

    Yamakawa, K. A.

    1983-01-01

    Slide rule relates efficiency, impurity types, impurity concentrations, and process types. Solar cell slide rule calculations are determination of allowable impurity concentration for nonredistributive process, determination of impurity buildup factor for redistributive process and determination of allowable impurity concentration for redistributive process.

  14. 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

    .... 02D-0049, now Docket No. FDA- 2002-D-0094, 67 FR 6545, February 12, 2002). The draft guidance was... comment (72 FR 61657, October 31, 2007). The Agency reviewed the submitted comments on the January 2002..., and increased the consistency and clarity of the process (73 FR 45459, August 5, 2008) (...

  15. Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.

    PubMed

    Smith, Jeffrey K

    2013-04-01

    Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database. PMID:23269527

  16. 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

  17. 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

  18. 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

  19. FDA changes clozapine monitoring guidelines: Implications for worldwide practice.

    PubMed

    Bastiampillai, Tarun; Gupta, Arun; Allison, Stephen

    2016-06-01

    US FDA decision to change their clozapine monitoring guidelines in 2015 for the first time. The changes proposed are as follows: lowering the neutrophil count before ceasing clozapine from 1.5 to 1.0×10(9)/l, allowing the potential for re-challenge following severe neutropenia (<1.0×10(9)/l) and allowing those with benign ethnic neutropenia the opportunity to be commenced on clozapine. These changes will allow a greater number of patients with schizophrenia in USA to be continued on clozapine. In our correspondence we summarize the evidence that support these changes. The FDA changes will likely have impact on clozapine monitoring protocols in other countries. PMID:27208449

  20. 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

  1. 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

  2. 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.

  3. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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...

  4. FDA Approves New Drug for Chronic Lymphocytic Leukemia in Patients with a Specific Chromosomal Abnormality

    MedlinePlus

    ... Newsroom Press Announcements FDA News Release FDA approves new drug for chronic lymphocytic leukemia in patients with ... of leukemia in adults, with approximately 15,000 new cases diagnosed each year. CLL is characterized by ...

  5. 21 CFR 830.100 - FDA accreditation of an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... according to a single set of consistent, fair, and reasonable terms and conditions. (5) Will protect...

  6. 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 ...

  7. 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.

  8. 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

  9. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance.

    PubMed

    Ball, R; Robb, M; Anderson, S A; Dal Pan, G

    2016-03-01

    In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products. PMID:26667601

  10. 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. PMID:20413118

  11. 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.

  12. 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.

  13. 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

  14. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... exclusive marketing rights, FDA will publish this information in the Federal Register at the time of the... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

  15. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... undertake such work through existing or new committees. Whether a particular committee working under such...

  16. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... undertake such work through existing or new committees. Whether a particular committee working under such...

  17. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... 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 collection... techniques, when appropriate, and other forms of information technology. FDA Recall Regulations--21 CFR...

  18. 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.

  19. 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.

  20. Rough viscoelastic sliding contact: Theory and experiments

    NASA Astrophysics Data System (ADS)

    Carbone, G.; Putignano, C.

    2014-03-01

    In this paper, we show how the numerical theory introduced by the authors [Carbone and Putignano, J. Mech. Phys. Solids 61, 1822 (2013), 10.1016/j.jmps.2013.03.005] can be effectively employed to study the contact between viscoelastic rough solids. The huge numerical complexity is successfully faced up by employing the adaptive nonuniform mesh developed by the authors in Putignano et al. [J. Mech. Phys. Solids 60, 973 (2012), 10.1016/j.jmps.2012.01.006]. Results mark the importance of accounting for viscoelastic effects to correctly simulate the sliding rough contact. In detail, attention is, first, paid to evaluate the viscoelastic dissipation, i.e., the viscoelastic friction. Fixed the sliding speed and the normal load, friction is completely determined. Furthermore, since the methodology employed in the work allows to study contact between real materials, a comparison between experimental outcomes and numerical prediction in terms of viscoelastic friction is shown. The good agreement seems to validate—at least partially—the presented methodology. Finally, it is shown that viscoelasticity entails not only the dissipative effects previously outlined, but is also strictly related to the anisotropy of the contact solution. Indeed, a marked anisotropy is present in the contact region, which results stretched in the direction perpendicular to the sliding speed. In the paper, the anisotropy of the deformed surface and of the contact area is investigated and quantified.

  1. Injecting Puragen Plus into the nasolabial folds: preliminary observations of FDA trial.

    PubMed

    Kinney, Brian M

    2006-01-01

    Based on participation in ongoing FDA trials, the author presents his initial impressions of Puragen Plus for treatment of the nasolabial folds. Puragen and Puragen Plus (Mentor Corp., Santa Barbara, CA) are double-cross-linked NASHA products. Depending on double cross-linking for duration of effect, instead of a varying particle size, may allow for use of one filler at all levels in the soft tissue. Other features observed by the author in the clinical setting included reduced injection pain, minimal erythema and tenderness, typically 9 to 12 months' duration of effect, and high patient satisfaction. PMID:19338969

  2. 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.

  3. 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.

  4. Lectin approaches for glycoproteomics in FDA-approved cancer biomarkers.

    PubMed

    Badr, Haitham A; Alsadek, Dina M M; Darwish, Ashraf A; Elsayed, Abdelaleim I; Bekmanov, Bakhytzhan O; Khussainova, Elmira M; Zhang, Xueji; Cho, William C S; Djansugurova, Leyla B; Li, Chen-Zhong

    2014-04-01

    The nine FDA-approved protein biomarkers for the diagnosis and management of cancer are approaching maturity, but their different glycosylation compositions relevant to early diagnosis still remain practically unexplored at the sub-glycoproteome scale. Lectins generally exhibit strong binding to specific sub-glycoproteome components and this property has been quite poorly addressed as the basis for the early diagnosis methods. Here, we discuss some glycoproteome issues that make tackling the glycoproteome particularly challenging in the cancer biomarkers field and include a brief view for next generation technologies. PMID:24611567

  5. Creative penmanship in animal testing prompts FDA controls.

    PubMed

    Smith, R J

    1977-12-23

    Inaccurate science, sloppy science, fraudulent science-these are the greatest threats to the health and safety of the American people. Whether the science is wrong because of clerical error, or because of poor technique, or because of incompetence, or because of negligence, is less important than the fact that it is wrong. For if it is wrong, and if the FDA did not know it was wrong, then the protective regulatory barrier between a potentially dangerous drug and the patient is removed.-SENATOR EDWARD KENNEDY (D-Mass.), in congressional hearings on preclinical testing. PMID:17741687

  6. 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

  7. 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

  8. Virtual slides: application in pulmonary pathology consultations.

    PubMed

    Słodkowska, Janina; Chyczewski, Lech; Wojciechowski, Michał

    2008-01-01

    The Virtual Slide (VS) is an interactive microscope emulator that presents a complete digitized tissue section via the Internet. A successful implementation of VS has been observed for educational, research venues and quality control. VS acquisition for consultative pathology is not so common. The purpose of this study was to explore the efficacy and usability of VS in the consultative pulmonary telepathology. 20 lung tumors entered the study. The performance was programmed for 2 medical centers specialized in pulmonary pathology (beginner and advancer in telepathology). A high-quality VSs were prepared by Coolscope (Nikon, Eclipsnet VSL, Japan), and were evaluated via the Internet. The cases were reviewed for the second time with conventional light microscope. VS diagnostic accuracy and the interobserver variability were evaluated. Also the time taken by examiners to render the diagnoses and time needed to scan the microscopic slide were analyzed. Percentage concordance between original glass-slides diagnosis and diagnosis for VSs was very high. Pathologists found the download speed of VSs adequate; experience in telepathology reduced the time of VS diagnosis. VS implementation suggests advantages for teleconsulation and education but also indicate some technical limitations. This is the first Polish trial of VS implementation in telepathology consultative service. PMID:18296275

  9. 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

  10. Possible FDA-approved drugs to treat Ebola virus infection.

    PubMed

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally, the estrogen receptor modulators Clomiphene and Toremifene prevent membrane fusion of EBOV and 50-90% of treated mice survived after Clomiphene/Toremifene treatments. However, the uptake efficiency of Clomiphene by oral administration is very low. Thus, I propose a hypothetical treatment protocol to treat Ebola virus infection with a cumulative use of both Miglustat and Toremifene to inhibit the virus effectively and synergistically. EBOV infection induces massive apoptosis of peripheral lymphocytes. Also, cytolysis of endothelial cells triggers disseminated intravascular coagulation (DIC) and subsequent multiple organ failures. Therefore, blood transfusions and active treatments with FDA-approved drugs to treat DIC are also recommended. PMID:25984303

  11. 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

  12. 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.

  13. Creating Slide Show Book Reports.

    ERIC Educational Resources Information Center

    Taylor, Harriet G.; Stuhlmann, Janice M.

    1995-01-01

    Describes the use of "Kid Pix 2" software by fourth grade students to develop slide-show book reports. Highlights include collaboration with education majors from Louisiana State University, changes in attitudes of the education major students and elementary students, and problems with navigation and disk space. (LRW)

  14. 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.

  15. 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…

  16. 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. PMID:24561349

  17. 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

  18. 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

  19. Large Eddy Simulation of FDA's Idealized Medical Device.

    PubMed

    Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H

    2013-12-01

    A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered. PMID:24187599

  20. [Introduction of U.S. FDA mini-sentinel program].

    PubMed

    Xie, Yan-Ming; Liao, Xing; Shen, Hao

    2013-03-01

    In China, all of traditional Chinese medicine injections should pass clinical trials I, II and III for their safety and effectiveness before coming into the market. However, these clinical tests are mostly restricted to standard treatment for specific groups, and conducted in strict accordance with clinical trial protocols. In the real world, as there are more changes in the post-market clinical application of traditional Chinese medicine injections than in the experiment environment, regulatory bodies set stricter requirements for the post-market re-assessment on traditional Chinese medicine injections. Early-stage studies could only provide the most fundamental and restricted data of efficacy and safety of traditional Chinese medicine injections. In this essay, mini-sentinel program of U. S. FDA is introduced in order to provide reference for large-sample-size post-market clinical safety monitoring studies for traditional Chinese medicine injections. PMID:23724692

  1. 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

  2. The FDA's new advice on fish: it's complicated.

    PubMed

    Wenstrom, Katharine D

    2014-11-01

    The Food and Drug Administration and Environmental Protection Agency recently issued an updated draft of advice on fish consumption for pregnant and breastfeeding women, after survey data indicated that the majority of pregnant women do not eat much fish and thus may have inadequate intake of the omega 3 fatty acids eicosapentaenoic acid [EPA] and ducosahexaenoic acid [DHA]. Omega 3 fatty acids are essential components of membranes in all cells of the body and are vitally important for normal development of the brain and retinal tissues (especially myelin and retinal photoreceptors) and for maintenance of normal neurotransmission and connectivity. They also serve as substrates for the synthesis of a variety of antiinflammatory and inflammation-resolving mediators, favorably alter the production of thromboxane and prostaglandin E2, and improve cardiovascular health by preventing fatal arrhythmias and reducing triglyceride and C-reactive protein levels. Maternal ingestion of adequate quantities of fish (defined in many studies as at least 340 g of oily fish each week) has been associated with better childhood IQ scores, fine motor coordination, and communication and social skills, along with other benefits. Although the FDA did not clarify which fish to eat, it specifically advised against eating fish with the highest mercury levels and implied that fish with high levels of EPA and DHA and low levels of mercury are ideal. The FDA draft did not recommend taking omega 3 fatty acid or fish oil supplements instead of eating fish, which is advice that may reflect the fact that randomized controlled trials of DHA and EPA or fish oil supplementation generally have been disappointing and that the ideal daily dose of DHA and EPA is unknown. It seems safe to conclude that pregnant and nursing women should be advised to eat fish to benefit from naturally occurring omega 3 fatty acids, to avoid fish with high levels of mercury and other contaminants, and, if possible, to choose

  3. 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.

  4. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

  5. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

  6. 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,…

  7. On-Line Retrieval of Clinical Slides.

    ERIC Educational Resources Information Center

    Milgrom, Linda

    The Physical Diagnosis Slide Bank, a collaborative project of the Universities of Washington, California at San Diego, and Arizona, utilizes an online interactive computer program to access a collection of over 2000 teaching clinical slides. Searchable data elements for each slide in the bank include subject descriptors (MeSH); accession number;…

  8. 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…

  9. 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,…

  10. Electrically assisted drop sliding on inclined planes

    NASA Astrophysics Data System (ADS)

    't Mannetje, D. J. C. M.; Murade, C. U.; van den Ende, D.; Mugele, F.

    2011-01-01

    We demonstrate that electrowetting using alternating current (ac) voltage can be used to overcome pinning of small drops due to omnipresent heterogeneities on solid surfaces. By balancing contact angle hysteresis with gravity on inclined planes, we find that the critical electrowetting number for mobilizing drops is consistent with the voltage-dependent reduction in contact angle hysteresis in ac electrowetting. Moreover, the terminal velocity of sliding drops under ac electrowetting is found to increase linearly with the electrowetting number. Based on this effect, we present a prototype of a wiper-free windscreen.

  11. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

    PubMed

    Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B

    2016-07-01

    The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions. PMID:27116020

  12. The Introduction of Crystallographic Concepts Using Lap-Dissolve Slide Techniques.

    ERIC Educational Resources Information Center

    Bodner, George M.; And Others

    1980-01-01

    Describes a method using lap-dissolve slide techniques with two or more slide projectors focused on a single screen for presenting visual effects that show structural features in extended arrays of atoms, or ions involving up to several hundred atoms. Presents an outline of an introduction to the structures of crystalline solids. (CS)

  13. 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.

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

    SciTech Connect

    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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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...

  2. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

    PubMed

    Zimmerman, Mark

    2016-06-01

    According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. PMID:27251690

  3. 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

    ... on this topic in March 2010 (75 FR 11893, March 12, 2010) and draft proposals from this phase are... confidentiality of trade secrets and individually identifiable patient information. FDA is seeking public comment... information FDA has in its possession, while supporting the redaction of trade secrets and...

  4. 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,...

  5. 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…

  6. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... during the development phase of a biosimilar biological product. This draft guidance describes the Agency... development and review of biosimilar biological products. \\1\\ See http://www.fda.gov/downloads/Drugs... between sponsors or applicants and FDA for biosimilar biological product development (BPD) programs. It...

  7. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Committees working under a contract with FDA. 14... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory... public advisory committee. Those principles are set out or cross-referenced in this part and in part...

  8. 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 ...

  9. 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]. PMID:22481744

  10. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013.......

  11. 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

    ... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  12. 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. PMID:23397880

  13. Improved landslide-tsunami prediction: Effects of block model parameters and slide model

    NASA Astrophysics Data System (ADS)

    Heller, Valentin; Spinneken, Johannes

    2013-03-01

    Subaerial landslide-tsunamis and impulse waves are caused by mass movements impacting into a water body, and the hazards they pose have to be reliably assessed. Empirical equations developed with physical Froude model studies can be an efficient method for such predictions. The present study improves this methodology and addresses two significant shortcomings in detail for the first time: these are the effect of three commonly ignored block model parameters and whether the slide is represented by a rigid block or a deformable granular material. A total of 144 block slide tests were conducted in a wave flume under systematic variation of three important block model parameters, the slide Froude number, the relative slide thickness, and the relative slide mass. Empirical equations for the maximum wave amplitude, height, and period as well as their evolution with propagation distance are derived. For most wave parameters, remarkably small data scatter is achieved. The combined influence of the three block model parameters affects the wave amplitude and wave height by up to a factor of two. The newly derived equations for block slides are then related to published equations for granular slides. This comparison reveals that block slides do not necessarily generate larger waves than granular slides, as often argued in the technical literature. In fact, it is shown that they may also generate significant smaller waves. The new findings can readily be integrated in existing hazard assessment methodologies, and they explain a large part of the discrepancy between previously published data.

  14. 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.

  15. A semi-probabilistic assessment method for flow slides

    NASA Astrophysics Data System (ADS)

    van den Ham, G.; Mastbergen, D.; de Groot, M.

    2013-12-01

    Flow slides in submerged slopes in non-lithified sandy and silty sediments form a major threat for flood defences along (estuary) coastlines and riverbanks in the Netherlands. Such flow slides may result in failure of levees and structures, eventually leading to flooding of the hinterland. Flow slide is a complex failure mechanism that includes both soil mechanical and hydraulic features. Two important sub-mechanisms are static liquefaction and breach flow. Static liquefaction entails the sudden loss of strength of loosely packed saturated sand or silt resulting in a collapse of the sand body. Breach flow is a more superficial process, involving the upslope retrogression of a local steep part of the slope which generates a turbulent sand-water mixture flow along the sand surface of the under water slope. Both mechanisms need a trigger, e.g. local steepening of the slope by erosion or slip failure. Although a breach flow slide generally takes more time than a liquefaction flow slide, both mechanisms result in a flowing sand-water mixture, that eventually resedimentates under a very gentle slope. Therefore in the analysis of historical flow slides it is often not clear to what extent static soil liquefaction and/or breach flow has played a role. In the current Dutch practice the prediction of levee failure due to flow sliding is based on either simple but conservative empirical rules based on documented historical flow slides in which distinction between mentioned sub-mechanisms is disregarded, or rather complex physical-based models describing mechanisms such as static liquefaction or breach flow. It will be presented how both approaches can be combined into a practical, probabilistic method for assessing dike failure due to flow sliding, accounting for uncertainties of the main influence factors. The method has recently been implemented in the so-called Dike Analysis Module (DAM). DAM is a platform for performing semi-automatic stability analyses on a large number

  16. AMERICANARUM DIATOMARUM EXISCCATA: CANA, VOUCHER SLIDES FROM EIGHT ACIDIC LAKES IN NORTHEASTERN NORTH AMERICA

    EPA Science Inventory

    Ninety-eight slides from eight lakes in the Adirondack Mountains of the northeastern United States have been distributed as an exsiccata to 16 museums and collections around the world. his exsiccata presents slides of material from sediments of Adirondack Mountain lakes that were...

  17. "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.

  18. 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…

  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. 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.

  1. Morphological response of diamond films in dry sliding contact

    NASA Astrophysics Data System (ADS)

    Languell, M. L.; George, M. A.; Wert, J. J.; Davidson, T. L.

    1994-07-01

    Reciprocating dry sliding friction tests performed on diamond-coated tungsten substrates produced changes in the surface morphology. A right-cylinder-on-flat geometry was used for the tribotesting. The morphological changes were investigated with scanning electron and atomic force microscopy. The composition of the diamond film was determined with Raman spectroscopy. The frictional response of the coating is examined in relation to the surface changes. A wear model for diamond films in dry sliding contact based on the morphological response is presented.

  2. Estimation of drug dosage regimens with a pharmacokinetic slide rule.

    PubMed

    Straughn, A B; Cruze, C A; Meyer, M C

    1977-02-01

    A pharmacokinetic slide rule to facilitate the computations based on relatively simple pharmacokinetic principles involved in the development of individualized drug dosage regimens is described. The calculations are based on the assumption that the body can be conceived as a one-compartment open model with drug elimination proceeding by apparent first-order kinetics. Examples are presented (1) to illustrate the clinical application of a slide rule to compute the time-course of drug in the body, (2) to calculate steady-state maximum and minimum levels, and accumulation during multiple dosage and (3) to estimate appropriate maintenance doses and intravenous infusion rates. PMID:842548

  3. Pleistocene Suvero slide, Paola basin, southern Italy

    USGS Publications Warehouse

    Trincardi, F.; Normark, W.R.

    1989-01-01

    The Suvero slide covers an area of about 225 km2 in the Paola slope basin on the Eastern Tyrrhenian margin. The shape and lateral extent of the deposit reflect topographic confinement of the slide between the continental slope and a morphologic barrier formed by a margin-parallel slope ridge. No headwall or slide plane comparable in scale with the slide deposit were found, suggesting that quasi in situ deformation of semi-consolidated sediments took place when the failed materials reached the floor of the slope basin. The failure occurred downslope from a basement high originating from local uplift. Continued uplift, after the Suvero slide occurred, is documented by the presence of steep upper-slope gradients within the study area and by the presence of small-scale creep and failure events that postdate the Suvero slide. ?? 1989.

  4. 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

  5. 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.

  6. 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.

  7. 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)

  8. "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

  9. 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

  10. 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

  11. The FDA And ABCs: Unintended Consequences Of Antidepressant Warnings On Human Capital*

    PubMed Central

    Busch, Susan H.; Golberstein, Ezra; Meara, Ellen

    2014-01-01

    Using annual cross-sectional data on over 100,000 adolescents aged 12-17, we studied academic and behavioral outcomes among those who were and were not likely affected by FDA warnings regarding the safety of antidepressants. Compared to other adolescents, adolescents with probable depression experienced a relative decline in grade point average of .14 points following the FDA warnings. The FDA warnings also coincided with increased delinquency, use of tobacco and use of illicit drugs. Together, our results stress the importance of mental health and its treatment as an input into cognitive and non-cognitive aspects of human capital. PMID:25284886

  12. 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

    ... (76 FR 45820), FDA published a notice establishing fee rates for FY 2012 for domestic and foreign... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  13. A novel sliding-mode control of induction motor using space vector modulation technique.

    PubMed

    Fu, Tian-Jun; Xie, Wen-Fang

    2005-10-01

    This paper presents a novel sliding-mode control method for torque control of induction motors. The control principle is based on sliding-mode control combined with space vector modulation technique. The sliding-mode control contributes to the robustness of induction motor drives, and the space vector modulation improves the torque, flux, and current steady-state performance by reducing the ripple. The Lyapunov direct method is used to ensure the reaching and sustaining of sliding mode and stability of the control system. The performance of the proposed system is compared with those of conventional sliding-mode controller and classical PI controller. Finally, computer simulation results show that the proposed control scheme provides robust dynamic characteristics with low torque ripple. PMID:16294775

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

    NASA Astrophysics Data System (ADS)

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

    2007-12-01

    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.

  15. 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.

  16. 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

  17. 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.

  18. 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.…

  19. FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk

    MedlinePlus

    ... nih.gov/medlineplus/news/fullstory_158144.html FDA: 2 Diabetes Drugs May Be Linked to Heart Failure ... Food and Drug Administration said. People with type 2 diabetes who use these drugs should not stop ...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  1. 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...

  2. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

  3. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  4. 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)...

  5. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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...

  6. Don't Take Short Cuts with Contact Lens Care, FDA Warns

    MedlinePlus

    ... With Contact Lens Care, FDA Warns Solutions with hydrogen peroxide can cause eye damage if two-step ... News) -- If you use contact lens solution with hydrogen peroxide and don't follow the instructions carefully, ...

  7. 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 ...

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

    MedlinePlus

    ... medlineplus.gov/news/fullstory_160237.html FDA: Anti-Aging, Skin-Lightening Products May Contain Mercury How you ... is often found in cosmetics marketed as "anti-aging" or "skin lightening" that claim to remove age ...

  9. Young LGBT Adults Are Target of FDA Stop-Smoking Campaign

    MedlinePlus

    ... Young LGBT Adults Are Target of FDA Stop-Smoking Campaign Tobacco use is common among these 18- ... and Drug Administration has launched an LGBT stop-smoking campaign. "We know LGBT young adults in this ...

  10. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... established for the application in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm....

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

    MedlinePlus

    ... news/fullstory_160573.html Use of Cancer-Linked Fibroid Device Declines After FDA Warning Rate of uterus ... of noncancerous growths on the uterus known as fibroids, they slice the tissue into smaller pieces that ...

  12. Sliding induced crystallization of metallic glass

    NASA Technical Reports Server (NTRS)

    Miyoshi, K.; Buckley, D. H.

    1983-01-01

    Sliding friction and wear experiments, electron microscopy, and diffraction studies were conducted with an Fe67Co18B14Si1 ferrous-base metallic glass in sliding contact with aluminum oxide at room temperature in air. The results indicate that the amorphous alloy can be crystallized during the sliding process. Crystallization of the wear surface causes high friction. Plastic flow occurred on the amorphous alloy with sliding, and the flow film of the alloy transferred to the aluminum oxide surface. Two distinct types of wear debris were observed as a result of sliding: an alloy wear debris, and powdery and whiskery oxide debris. Generation of oxide wear debris particles on an alloy can cause transitions in friction behavior.

  13. Peeling, sliding, pulling and bending

    NASA Astrophysics Data System (ADS)

    Lister, John; Peng, Gunnar

    2015-11-01

    The peeling of an elastic sheet away from thin layer of viscous fluid is a simply-stated and generic problem, that involves complex interactions between the flow and elastic deformation on a range of length scales. Consider an analogue of capillary spreading, where a blister of injected viscous fluid spreads due to tension in the overlying elastic sheet. Here the tension is coupled to the deformation of the sheet, and thus varies in time and space. A key question is whether or not viscous shear stresses ahead of the blister are sufficient to prevent the sheet sliding inwards and relieving the tension. Our asymptotic analysis reveals a dichotomy between fast and slow spreading, and between two-dimensional and axisymmetric spreading. In combination with bending stresses and gravity, which may dominate parts of the flow but not others, there is a plethora of dynamical regimes.

  14. 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

  15. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    PubMed

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. PMID:20575403

  16. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  17. 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 subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  18. Efficient sliding spotlight SAR raw signal simulation of extended scenes

    NASA Astrophysics Data System (ADS)

    Xu, Wei; Huang, Pingping; Deng, Yunkai

    2011-12-01

    Sliding spotlight mode is a novel synthetic aperture radar (SAR) imaging scheme with an achieved azimuth resolution better than stripmap mode and ground coverage larger than spotlight configuration. However, its raw signal simulation of extended scenes may not be efficiently implemented in the two-dimensional (2D) Fourier transformed domain. This article presents a novel sliding spotlight raw signal simulation approach from the wide-beam SAR imaging modes. This approach can generate sliding spotlight raw signal not only from raw data evaluated by the simulators, but also from real data in the stripmap/spotlight mode. In order to obtain the desired raw data from conventional stripmap/spotlight mode, the azimuth time-varying filtering, which is implemented by de-rotation and low-pass filtering, is adopted. As raw signal of extended scenes in the stripmap/spotlight mode can efficiently be evaluated in the 2D Fourier domain, the proposed approach provides an efficient sliding spotlight SAR simulator of extended scenes. Simulation results validate this efficient simulator.

  19. 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

  20. 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

  1. Antidepressants and Suicide Risk: How Did Specific Information in FDA Safety Warnings Affect Treatment Patterns?

    PubMed Central

    Busch, Susan H.; Frank, Richard G.; Leslie, Doug; Martin, Andres; Martin, Erika; Rosenheck, Robert; Barry, Colleen L.

    2009-01-01

    Objective From June 2003 through October 2004, the Food and Drug Administration (FDA) released five safety warnings related to antidepressant use and increased suicide risk in children. While researchers have documented a decline in antidepressant use in children over this time period, less is known about whether specific safety information conveyed in individual warnings was reflected in treatment patterns. Methods Thomson Marketscan claims data (2001–2005) for a national sample of privately insured children were used to construct treatment episodes (N=23,529). For each new episode of major depressive disorder, it was determined whether children’s treatment followed specific recommendations included in warnings released by the FDA. Treatment recommendations pertained to the use of the antidepressants paroxetine and fluoxetine and to patient monitoring. Treatment patterns were expected to change as the nature of risk information conveyed by the FDA changed over time. Results The timing of FDA recommendations was associated with trends in the use of paroxetine and fluoxetine by children with major depressive disorder newly initiating antidepressant treatment. However, no evidence of increases in outpatient visits (i.e., monitoring) among depressed children initiating antidepressants was found. Conclusions Release of specific risk and benefit information by the FDA was associated with changes in prescribing, but not outpatient follow-up. These results suggest the FDA plays an important role in communicating information to the public and providers, but while public health safety warnings were associated with changes in some practice patterns, not all recommendations conveyed in warnings were followed. PMID:20044412

  2. 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. PMID:11362892

  3. 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.

  4. 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

  5. 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. PMID:24913067

  6. The Use of Slides in Psychology Classes: Do They Help or Are They an Invitation to Sleep?

    ERIC Educational Resources Information Center

    Beins, Barney

    1984-01-01

    The effectiveness of a Sensation and Perception course was improved when the teacher used slides in his presentations. Using slides allows smoother presentation of the material, speeds the pace of the class without confusing students, and provides them with a more positive experience in dealing with a difficult psychology course. (RM)

  7. 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

  8. An updated nuclear criticality slide rule

    SciTech Connect

    Hopper, C.M.; Broadhead, B.L.

    1998-04-01

    This Volume 2 contains the functional version of the updated nuclear criticality slide rule (more accurately, sliding graphs) that is referenced in An Updated Nuclear Criticality Slide Rule: Technical Basis, NUREG/CR-6504, Vol. 1 (ORNL/TM-13322/V1). This functional slide rule provides a readily usable {open_quotes}in-hand{close_quotes} method for estimating pertinent nuclear criticality accident information from sliding graphs, thereby permitting (1) the rapid estimation of pertinent criticality accident information without laborious or sophisticated calculations in a nuclear criticality emergency situation, (2) the appraisal of potential fission yields and external personnel radiation exposures for facility safety analyses, and (3) a technical basis for emergency preparedness and training programs at nonreactor nuclear facilities. The slide rule permits the estimation of neutron and gamma dose rates and integrated doses based upon estimated fission yields, distance from the fission source, and time-after criticality accidents for five different critical systems. Another sliding graph permits the estimation of critical solution fission yields based upon fissile material concentration, critical vessel geometry, and solution addition rate. Another graph provides neutron and gamma dose-reduction factors for water, steel, and concrete. Graphs from historic documents are provided as references for estimating critical parameters of various fissile material systems. Conversion factors for various English and metric units are provided for quick reference.

  9. 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

  10. 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

  11. 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.

  12. SlideToolkit: An Assistive Toolset for the Histological Quantification of Whole Slide Images

    PubMed Central

    Nelissen, Bastiaan G. L.; van Herwaarden, Joost A.; Moll, Frans L.; van Diest, Paul J.; Pasterkamp, Gerard

    2014-01-01

    The demand for accurate and reproducible phenotyping of a disease trait increases with the rising number of biobanks and genome wide association studies. Detailed analysis of histology is a powerful way of phenotyping human tissues. Nonetheless, purely visual assessment of histological slides is time-consuming and liable to sampling variation and optical illusions and thereby observer variation, and external validation may be cumbersome. Therefore, within our own biobank, computerized quantification of digitized histological slides is often preferred as a more precise and reproducible, and sometimes more sensitive approach. Relatively few free toolkits are, however, available for fully digitized microscopic slides, usually known as whole slides images. In order to comply with this need, we developed the slideToolkit as a fast method to handle large quantities of low contrast whole slides images using advanced cell detecting algorithms. The slideToolkit has been developed for modern personal computers and high-performance clusters (HPCs) and is available as an open-source project on github.com. We here illustrate the power of slideToolkit by a repeated measurement of 303 digital slides containing CD3 stained (DAB) abdominal aortic aneurysm tissue from a tissue biobank. Our workflow consists of four consecutive steps. In the first step (acquisition), whole slide images are collected and converted to TIFF files. In the second step (preparation), files are organized. The third step (tiles), creates multiple manageable tiles to count. In the fourth step (analysis), tissue is analyzed and results are stored in a data set. Using this method, two consecutive measurements of 303 slides showed an intraclass correlation of 0.99. In conclusion, slideToolkit provides a free, powerful and versatile collection of tools for automated feature analysis of whole slide images to create reproducible and meaningful phenotypic data sets. PMID:25372389

  13. 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.

  14. Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

    PubMed

    Cohen, Michael H

    2003-01-01

    The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is

  15. Microwave irradiation of human brain tissue: production of microscopic slides within one day.

    PubMed Central

    Boon, M E; Marani, E; Adriolo, P J; Steffelaar, J W; Bots, G T; Kok, L P

    1988-01-01

    A three step method using microwave irradiation enabled microscopic slides of human brain tissue to be obtained within one working day: steps 1 and 2 hardened and solidified brain tissue; step 3 completed formalin fixation. The efficacy and precision of the method was compared with slides of conventionally processed brain tissue that had been fixed in formalin for six weeks. The microscopic quality of the sections was excellent with good presentation of brain tissue and equalled that of conventionally processed slides. Images Fig 1 Fig 2 Fig 3 PMID:3290268

  16. 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.

  17. Color standardization in whole slide imaging using a color calibration slide

    PubMed Central

    Bautista, Pinky A.; Hashimoto, Noriaki; Yagi, Yukako

    2014-01-01

    Background: Color consistency in histology images is still an issue in digital pathology. Different imaging systems reproduced the colors of a histological slide differently. Materials and Methods: Color correction was implemented using the color information of the nine color patches of a color calibration slide. The inherent spectral colors of these patches along with their scanned colors were used to derive a color correction matrix whose coefficients were used to convert the pixels’ colors to their target colors. Results: There was a significant reduction in the CIELAB color difference, between images of the same H & E histological slide produced by two different whole slide scanners by 3.42 units, P < 0.001 at 95% confidence level. Conclusion: Color variations in histological images brought about by whole slide scanning can be effectively normalized with the use of the color calibration slide. PMID:24672739

  18. AAPS-FDA workshop white paper: microdialysis principles, application and regulatory perspectives.

    PubMed

    Chaurasia, Chandra S; Müller, Markus; Bashaw, Edward D; Benfeldt, Eva; Bolinder, Jan; Bullock, Ross; Bungay, Peter M; DeLange, Elizabeth C M; Derendorf, Hartmut; Elmquist, William F; Hammarlund-Udenaes, Margareta; Joukhadar, Christian; Kellogg, Dean L; Lunte, Craig E; Nordstrom, Carl Henrik; Rollema, Hans; Sawchuk, Ronald J; Cheung, Belinda W Y; Shah, Vinod P; Stahle, Lars; Ungerstedt, Urban; Welty, Devin F; Yeo, Helen

    2007-05-01

    Many decisions in drug development and medical practice are based on measuring blood concentrations of endogenous and exogenous molecules. Yet most biochemical and pharmacological events take place in the tissues. Also, most drugs with few notable exceptions exert their effects not within the bloodstream, but in defined target tissues into which drugs have to distribute from the central compartment. Assessing tissue drug chemistry has, thus, for long been viewed as a more rational way to provide clinically meaningful data rather than gaining information from blood samples. More specifically, it is often the extracellular (interstitial) tissue space that is most closely related to the site of action (biophase) of the drug. Currently microdialysis (microD) is the only tool available that explicitly provides data on the extracellular space. Although microD as a preclinical and clinical tool has been available for two decades, there is still uncertainty about the use of microD in drug research and development, both from a methodological and a regulatory point of view. In an attempt to reduce this uncertainty and to provide an overview of the principles and applications of microD in preclinical and clinical settings, an AAPS-FDA workshop took place in November 2005 in Nashville, TN, USA. Stakeholders from academia, industry and regulatory agencies presented their views on microD as a tool in drug research and development. PMID:17458685

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

    SciTech Connect

    Herrera-Fierro, P.; Masuko, M.; Jones, W.R. Jr.; Pepper, S.V.

    1994-04-01

    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.

  20. 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.

  1. Computer-aided prognosis of neuroblastoma: classification of stromal development on whole-slide images

    NASA Astrophysics Data System (ADS)

    Sertel, Olcay; Kong, Jun; Shimada, Hiroyuki; Catalyurek, Umit; Saltz, Joel H.; Gurcan, Metin

    2008-03-01

    Neuroblastoma is a cancer of the nervous system and one of the most common tumors in children. In clinical practice, pathologists examine the haematoxylin and eosin (H&E) stained tissue slides under the microscope for the diagnosis. According to the International Neuroblastoma Classification System, neuroblastoma tumors are categorized into favorable and unfavorable histologies. The subsequent treatment planning is based on this classification. However, this qualitative evaluation is time consuming, prone to error and subject to inter- and intra-reader variations and sampling bias. To overcome these shortcomings, we are developing a computerized system for the quantitative analysis of neuroblastoma slides. In this study, we present a novel image analysis system to determine the degree of stromal development from digitized whole-slide neuroblastoma samples. The developed method uses a multi-resolution approach that works similar to how pathologists examine slides. Due to their very large resolutions, the whole-slide images are divided into non-overlapping image tiles and the proposed image analysis steps are applied to each image tile using a parallel computation infrastructure developed earlier by our group. The computerized system classifies image tiles as stroma-poor or stroma-rich subtypes using texture characteristics. The developed method has been independently tested on 20 whole-slide neuroblastoma slides and it has achieved 95% classification accuracy.

  2. Slide Rule For Calculating Curing Schedules

    NASA Technical Reports Server (NTRS)

    Heater, Don

    1995-01-01

    Special-purpose slide rule devised for calculating schedules for storing and curing adhesives, sealants, and other materials characterized by known curing times and shelf lives. Prevents mistakes commonly made in determining storage and curing schedules.

  3. Water Slides: Look Before You Leap.

    ERIC Educational Resources Information Center

    Barks, Dan

    1986-01-01

    The Campbell County Parks and Recreation Department discovered that higher costs, more details, insurance difficulties, and longer construction periods were the rule when a water slide was planned and constructed. The project is described. (MT)

  4. 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.

  5. 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.

  6. Stereoscopic Projection of 35mm Slides.

    ERIC Educational Resources Information Center

    Carey, Edward F.

    1978-01-01

    Describes ways of projecting stereoscopic images of geologic environments for students with difficulty reasoning in three-dimensions. The photographic procedures needed to produce stereo slides are included. (MA)

  7. 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…

  8. 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…

  9. Speckle tracking technology for quantifying lung sliding.

    PubMed

    Dori, Guy; Jakobson, Daniel J

    2016-06-01

    Ultrasound (US) is gaining recognition as a useful tool for assessing lung physiology and pathology. Yet, currently the skill of performing lung US is taught by experienced operators to novice ones, mainly by recognizing expected patterns. Recognizing the latter may be difficult and subjective. In this hypothesis we propose to apply a well-known and used image processing technology in echocardiography, speckle tracking (ST), to lung sliding - the marker of normal lung function. If implementing ST to lung sliding is technically feasible, several outcomes are expected: (1) Lung sliding will become an objective, operator-independent marker of normal lung function. (2) Subsequently, ST will provide normal values for lung sliding. (3) Lastly, the effects of pulmonary pathologies on lung sliding may be assessed. It is stressed, however, that the preliminary idea suggested here is limited to a single physiological phenomenon (lung sliding). Only when technical feasibility is demonstrated then ST technology may potentially be applied and investigated in other clinical settings of lung diseases. PMID:27142150

  10. 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.

  11. Effect of display resolution on time to diagnosis with virtual pathology slides in a systematic search task.

    PubMed

    Randell, Rebecca; Ambepitiya, Thilina; Mello-Thoms, Claudia; Ruddle, Roy A; Brettle, David; Thomas, Rhys G; Treanor, Darren

    2015-02-01

    Performing diagnoses using virtual slides can take pathologists significantly longer than with glass slides, presenting a significant barrier to the use of virtual slides in routine practice. Given the benefits in pathology workflow efficiency and safety that virtual slides promise, it is important to understand reasons for this difference and identify opportunities for improvement. The effect of display resolution on time to diagnosis with virtual slides has not previously been explored. The aim of this study was to assess the effect of display resolution on time to diagnosis with virtual slides. Nine pathologists participated in a counterbalanced crossover study, viewing axillary lymph node slides on a microscope, a 23-in 2.3-megapixel single-screen display and a three-screen 11-megapixel display consisting of three 27-in displays. Time to diagnosis and time to first target were faster on the microscope than on the single and three-screen displays. There was no significant difference between the microscope and the three-screen display in time to first target, while the time taken on the single-screen display was significantly higher than that on the microscope. The results suggest that a digital pathology workstation with an increased number of pixels may make it easier to identify where cancer is located in the initial slide overview, enabling quick location of diagnostically relevant regions of interest. However, when a comprehensive, detailed search of a slide has to be made, increased resolution may not offer any additional benefit. PMID:25128321

  12. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.

    PubMed

    Kesselheim, A S; Darrow, J J

    2015-01-01

    New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating "substantial evidence" of efficacy. However, a number of legislative and regulatory initiatives, the most recent being the breakthrough therapy designation created in 2012, give the FDA flexibility to approve drugs on the basis of less rigorous data in situations of greater clinical need. These expedited development and review pathways now contribute to a majority of all new drug approvals and have important benefits in encouraging efficient availability of transformative drugs. They also have a number of risks, including a heightened possibility that the drugs will be discovered to be ineffective or unsafe after widespread use, and confusion by patients and physicians over what it means for a product to be "FDA approved." PMID:25670381

  13. The FDA's proposal for public disclosure of adverse events in gene therapy trials.

    PubMed

    Barnbaum, D R

    2000-09-01

    In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials. PMID:15468489

  14. 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

  15. Blood safety: Opportunities and challenges addressed through Critical Path research at FDA.

    PubMed

    Atreya, Chintamani D; Epstein, Jay S

    2007-01-01

    New scientific discoveries and technologies create opportunities for medical and public health advancement through development of innovative products. However, novel products and technologies bring new challenges to regulation. FDA recently established a 'Critical Path' research initiative to modernize regulatory science concepts and tools to meet the challenges of the 21st century. Central to this initiative is the concept that regulatory science is distinct from the 'discovery' science that generates ideas for development of new drugs, biologics, or medical devices. In this article, the authors discuss the concepts of FDA 'Critical Path' research and review examples of such research performed in the Office of Blood Research and Review within the Center for Biologics Research and Evaluation at FDA to illustrate how the 'Critical Path' research is being used to address opportunities and challenges impacting blood and blood products.: PMID:24980841

  16. 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.

  17. 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.

  18. 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.

  19. The giant submarine alika debris slide, Mauna Loa, Hawaii.

    USGS Publications Warehouse

    Lipman, P.W.; Normark, W.R.; Moore, J.G.; Wilson, J.B.; Gutmacher, C.E.

    1988-01-01

    A 4000-km2 area of submarine slump and slide deposits along the W flank of Mauna Loa volcano has been mapped with GLORIA side-scan sonar images, seismic reflection profiles, and new bathymetry. The youngest deposits are 2 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 2 lobes partly overlap and together are designated the Alika slide. They were derived from the same source area and probably formed in rapid succession. Slumping on Mauna Loa has been most intense adjacent to the large arcuate bend in its SW 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, landslides and distal submarine turbidity flows appear to be widespread on the flanks of Hawaiian volcanoes.-from Authors

  20. 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.

  1. Sahara Slide: Age, initiation, and processes of a giant submarine slide

    NASA Astrophysics Data System (ADS)

    Georgiopoulou, Aggeliki; Masson, Douglas G.; Wynn, Russell B.; Krastel, Sebastian

    2010-07-01

    The Sahara Slide is a giant submarine landslide on the northwest African continental margin. The landslide is located on the open continental slope offshore arid Western Sahara, with a headwall at a water depth of ˜2000 m. High primary productivity in surface waters drives accumulation of thick fine-grained pelagic/hemipelagic sediment sequences in the slide source area. Rare but large-scale slope failures, such as the Sahara Slide that remobilized approximately 600 km3 of sediment, are characteristic of this sedimentological setting. Seismic profiles collected from the slide scar reveal a stepped profile with two 100 m high headwalls, suggesting that the slide occurred retrogressively as a slab-type failure. Sediment cores recovered from the slide deposit provide new insights into the process by which the slide eroded and entrained a volcaniclastic sand layer. When this layer was entrained at the base of the slide it became fluidized and resulted in low apparent friction, facilitating the exceptionally long runout of ˜900 km. The slide location appears to be controlled by the buried headwall of an older slope failure, and we suggest that the cause of the slide relates to differential sedimentation rates and compaction across these scarps, leading to local increases of pore pressure. Sediment cores yield a date of 50-60 ka for the main slide event, a period of global sea level rise which may have contributed to pore pressure buildup. The link with sea level rising is consistent with other submarine landslides on this margin, drawing attention to this potential hazard during global warming.

  2. 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

  3. We really need to talk: adapting FDA processes to rapid change.

    PubMed

    Lykken, Sara

    2013-01-01

    The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system. PMID:24552079

  4. 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.

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

    NASA Astrophysics Data System (ADS)

    Geng, Yongliang; Zhu, Chunao; Zhang, Bo

    2014-03-01

    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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. High velocity sliding at polycrystalline ductile metal interfaces

    NASA Astrophysics Data System (ADS)

    Hammerberg, J. E.; Milhans, J. L.; Ravelo, R.; Germann, T. C.

    2014-03-01

    We present the results of large scale 3-dimensional NonEquilibrium Molecular Dynamics (NEMD) simulations for Al-Al and Al-Ta interfaces for sliding velocities in the range 20-4000 m/s at pressures of 15 GPa. System sizes include 8 M, 26 M and 138 M atoms for times to 40 ns. We discuss polycrystalline samples with initial grain sizes of 13 nm and 20 nm. For velocities above a size dependent critical velocity, vc, the frictional force per unit area agrees with single crystal simulations. For velocities below vc, the polycrystalline interfaces evolve to a new steady state grain size distribution characterized by very large plastic deformation with larger grain sizes, time dependent coarsening and refinement, a graded size distribution in the direction normal to the sliding interface, and significantly larger frictional forces per unit area compared to similar single crystal sliding interfaces. We also find that for the Al-Ta interface the frictional properties are determined by the weaker Al material. This work was performed under the auspices of the U.S. Dept. of Energy under contract DE-AC52-06NA25396. The support of the LANL ASC-PEM program is gratefully acknowledged.

  14. A slide-rule for assessment of venous admixture.

    PubMed

    Zetterström, H

    1989-04-01

    Determination of venous admixture (physiological shunt, Qva/Qt) requires analysis of both arterial and mixed venous blood. When a pulmonary arterial catheter is not in use, the pulmonary oxygenating capacity may be assessed from arterial blood gas data, the fraction of inspired oxygen (FIO2) and an assumed value of the arterial-mixed venous oxygen content difference. To facilitate this process, a slide-rule based on the "virtual shunt" concept is presented. It permits rapid assessment of Qva/Qt from known values of arterial oxygen tension (PaO2) or saturation (SaO2) and FIO2 and may promote the choice of appropriate FIO2. The limitations of the slide-rule were studied theoretically and its validity was tested by comparing 100 determinations of virtual shunt with the corresponding Qva/Qt values. The slide-rule was found to estimate Qva/Qt more accurately than commonly used oxygenation indices such as the PaO2/FIO2 ratio. PMID:2499154

  15. Devil's Slide: An evolving feature of California's coastal landscape

    NASA Astrophysics Data System (ADS)

    Thomas, M.; Loague, K.

    2013-12-01

    Coastal landslides in the United States remain a persistent threat to human life and urban development. The focus of this study is a landslide-prone section of the central California coastline, approximately 20 km south of San Francisco, known as Devil's Slide. This investigation employs an extensive aerial image inventory, digital elevation models (DEMs), and a water balance / limit-equilibrium approach to better understand the spatial and temporal characteristics of deep-seated bedrock slides at the site. Photographic surveys of the area reveal nearly three kilometers of headscarp and a complex network of slope failures that respond to hydrologic, seismic, and anthropogenic perturbations. DEM analysis suggests that, for a 145-year period (1866 to 2010), the study area experienced an average coastal retreat rate of 0.14 m yr-1 and an average volumetric loss of 11,216 m3 yr-1. At least 38% of the landscape evolution in the steep coastal terrain has been driven by slope failure events. A loosely coupled water balance / limit-equilibrium analysis quantitatively illustrates the precarious nature of the active landslide zone at the site. The slope is shown to be unstable for a large suite of equally-likely scenarios. The analyses presented herein suggest that future work should include a rigorous characterization of pore-water pressure development, driven by comprehensive simulations of subsurface hydrologic response, to improve our understanding of slope failure initiation at the Devil's Slide site.

  16. 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.

  17. 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. PMID:26353368

  18. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... response to a request for input from FDA on this topic in March 2010 (75 FR 11893, March 12, 2010... Policy, Planning, and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 4226...'' and directing the Director of the Office of Management and Budget (OMB) to issue an Open...

  19. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false How does FDA define the terms used in this part? 803.3 Section 803.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as amended. Ambulatory surgical facility...

  20. 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)

  1. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

    PubMed

    Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry

    2014-10-01

    Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse. PMID:25288421

  2. 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...

  3. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal...

  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. FDA's requirements for in-vivo performance data for prosthetic heart valves.

    PubMed

    Johnson, D M; Sapirstein, W

    1994-07-01

    The Food and Drug Administration (FDA) has recently revised its "Replacement Heart Valve Guidance". That document lists the data FDA deems necessary to support the approval of new prosthetic heart valves of all designs, and which should be contained in Premarket Approval Applications for these devices. The guidance covers detailed data requirements for in vitro, animal, and clinical data. This paper is intended to briefly summarize FDA's requirements for in vivo and clinical data. The clinical study must establish that the device is both safe and effective, as compared to currently marketed replacement heart valves. It is possible to achieve this goal using hypothesis testing to compare the results of an observational study against a set of Objective Performance Criteria (OPC) which have been established by the FDA. The establishment of the OPCs was facilitated by a standardized set of definitions of complications published by the American Association of Thoracic Surgery and Society of Thoracic Surgeons (AATS/STS) in 1987/1988. Papers published in peer reviewed journals have utilized this set of definitions for data analysis, providing an ample pool of data from which to establish OPCs. The number of patients required to establish the safety and efficacy of a replacement heart valve, using this approach, is 800 valve years, 400 in the aortic and 400 in the mitral position. Advantages of this approach are reduction in the number of patients and duration of the study. PMID:7952304

  6. 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...

  7. FDA Bioinformatics Tool for Microbial Genomics Research on Molecular Characterization of Bacterial Foodborne Pathogens Using Microarrays

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background: Advances in microbial genomics and bioinformatics are offering greater insights into the emergence and spread of foodborne pathogens in outbreak scenarios. The Food and Drug Administration (FDA) has developed the genomics tool ArrayTrackTM, which provides extensive functionalities to man...

  8. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of......

  9. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for 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...

  10. 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

  11. 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,…

  12. 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 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  13. 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...

  14. 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...

  15. 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 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...

  16. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  17. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... the document at http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/Running... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and...

  18. 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

  19. 76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... examine and update current good manufacturing practice requirements and to develop an animal feed safety... methods in manufacturing, processing, packing, and holding food and feed. FDA is interested in making... three of the following five break-out sessions: Preventive Controls Guidance, On- Farm Manufacturing...

  20. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for 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...

  1. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for 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...

  2. 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...

  3. 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.

  4. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

    PubMed

    Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015. PMID:25840884

  5. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.

    PubMed

    Alder, H C

    1993-10-01

    The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the

  6. 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.

  7. Do grain boundaries in nanophase metals slide?

    SciTech Connect

    Bringa, E M; Leveugle, E; Caro, A

    2006-10-27

    Nanophase metallic materials show a maximum in strength as grain size decreases to the nano scale, indicating a break down of the Hall-Petch relation. Grain boundary sliding, as a possible accommodation mechanisms, is often the picture that explain computer simulations results and real experiments. In a recent paper, Bringa et al. Science 309, 1838 (2005), we report on the observation of an ultra-hard behavior in nanophase Cu under shock loading, explained in terms of a reduction of grain boundary sliding under the influence of the shock pressure. In this work we perform a detailed study of the effects of hydrostatic pressure on nanophase Cu plasticity and find that it can be understood in terms of pressure dependent grain boundary sliding controlled by a Mohr-Coulomb law.

  8. 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.

  9. Experimental Testing of Glacier Sliding Laws

    NASA Astrophysics Data System (ADS)

    Zoet, L.; Iverson, N. R.

    2013-12-01

    Glacier sliding laws exist in various forms and are applied in modeling of glacier dynamics. Sliding laws have been, in most cases, theoretically derived but not experimentally tested. Under certain conditions ice sliding over a rigid bed will generate cavities in the lees of bedrock bumps. These cavities will redistribute shear stress to regions of the bed that are in contact with ice. Sliding laws that incorporate cavity formation relate drag to the maximum adverse slope of the region of ice-bed contact. Sinusoidal and stepped-bed geometries are, therefore, predicted to affect basal drag differently. A sinusoidal bed is predicted to have a double-valued drag response as a function of sliding velocity, whereas the steady-state drag on a stepped bed with linear adverse slopes is expected to be independent of sliding velocity. We have conducted an experimental study of sliding laws using a ring shear apparatus that slides ice over a rigid bed. The device rotates a ring of ice that is 20 cm wide, 20 cm tall, with outer diameter of 90 cm. The sliding speed at the ice ring's centerline was incrementally stepped between 7.25--324 m/yr, and a vertical stress of 500 kPa was applied to the ice ring. The ice consisted initially of randomly oriented crystals that with sliding quickly developed a fabric like those observed in ice near glacier beds. The temperature of the ice is held at the pressure melting point and is regulated to ~0.01oC by a bath of circulating fluid that surrounds the sample chamber. Experiments have been conducted on a stepped bed with a constant slope of 8.3 and a sinusoidal bed with a wavelength of 183.3 mm and an amplitude of 15.3 mm. Water was allowed to drain from cavities, so effective stress at the bed was equal to the total vertical stress. Our experimental results differ from theoretical predictions. For the stepped bed, a decrease in shear stress of ~50% over a 12-fold increase in velocity is observed, in contrast to theoretical predictions of

  10. 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

  11. 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

  12. 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

  13. 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. PMID:26038747

  14. 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…

  15. 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

  16. The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database.

    PubMed

    Raschi, E; Piccinni, C; Poluzzi, E; Marchesini, G; De Ponti, F

    2013-08-01

    In patients with diabetes, disease per se, co-morbidities and drugs, including novel agents acting on the incretin system, have all been associated with pancreatitis with controversial data. We investigated the publicly available FDA Adverse Event Reporting System (FDA_AERS) database to gain insight into the possible association between antidiabetic agents and pancreatitis. To this aim, a case/non-case method was retrospectively performed on the FDA_AERS database (2004-2009 period). Cases were defined as reports of pancreatitis according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. All other reports associated with antidiabetics were considered non-cases. The Reporting Odds Ratio (RORs), with corresponding 95% confidential interval (CI) and Mantel-Haenszel corrected P value, was calculated as a measure of disproportionality, with subsequent time-trend analysis. We retrieved 86,938 reports related to antidiabetics, corresponding to 159,226 drug-report combinations: 2,625 cases and 156,601 non-cases. Disproportionality was found only for exenatide (number of cases, 709; ROR, 1.76; 95% CI, 1.61-1.92; P MH < 0.001) and sitagliptin (128; 1.86; 1.54-2.24; <0.001). For exenatide, significant disproportionality appeared in the first quarter of 2008 (ROR, 1.24; 95% CI, 1.10-1.40; P MH < 0.001), soon after the FDA alert; for sitagliptin in the second quarter of 2008 (1.41; 1.05-1.90; 0.021). This temporal analysis found a striking influence of relevant FDA warnings on reporting of pancreatitis (the so-called notoriety bias) and is, therefore, recommended to avoid transforming a pharmacovigilance signal of alert automatically into an alarm. The precise quantification of the risk of pancreatitis associated with antidiabetics deserves assessment through specific disease-based registries. PMID:22008948

  17. FDA moves to permit oral contraceptive prescriptions without initial pelvic exam.

    PubMed

    1993-05-28

    The Planned Parenthood Federation of America (PPFA) submitted recommendations to the US Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee. The PPFA wanted the FDA to remove requirements for a pelvic examination and blood tests before an oral contraceptive (OC) is prescribed. Two representatives of the Family Planning Council of Southeastern Pennsylvania told the FDA advisory committee about the evaluation results of its Smart Start program. 23% of teenagers wanting to use OCs opted to delay the pelvic examination, and 40% opted to delay the blood tests. 83% of these same teenagers were already sexually active. 69% returned for pelvic exams at 3 months. Increased education and counseling over several sessions probably explained why more study participants used condoms and fewer of them became pregnant during the 6-month study. Physicians from the American College of Obstetricians and Gynecologists and the American Fertility Society also attended the committee hearing and supported PPFA's recommendations. The National Women's Health Network wanted to delay the discussion until the committee could also address the sale of OCs over-the-counter. The statements convinced the committee to allow physicians to defer to full physical examination as long as there are no contraindications. This May 20, 1993 approval emphasized the need for physicians to continue taking a complete medical history and conducting other tests that may uncover contraindications (e.g. pregnancy and blood pressure). FDA staff now must write the exact language needed for the OC labeling change to be approved by the FDA commissioner. PMID:12286460

  18. 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. PMID:25489841

  19. 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

  20. 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…

  1. 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

  2. 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. PMID:24718584

  3. Slide error measurement of a large-scale ultra-precision lathe

    NASA Astrophysics Data System (ADS)

    Lee, Jung Chul; Gao, Wei; Noh, Young Jin; Hwang, Joo Ho; Oh, Jeoung Seok; Park, Chun Hong

    2010-08-01

    This paper presents the measurement of the slide error of a large-scale ultra-precision lathe with an effective fabricating length of 2000 mm. A cylinder workpiece with a diameter of 320 mm and a length of 1500 mm was mounted on the spindle of the lathe with its rotational axis along the Z-direction. Two capacitive displacement probes with a measurement range of 100 μm were mounted on the slide of lathe with its moving axis along the Z-direction. The displacement probes were placed on the two sides of the cylinder workpiece over the horizontal plane (XZ-plane). The cylinder workpiece, which was rotated by the spindle, was scanned by the displacement probes moved by the slide. The X-directional horizontal slide error can be accurately evaluated from the probe outputs by using a proposed rotatingreversal method through separating the influences of the form error of the cylinder workpiece and the rotational error of the spindle. In addition to the out-of-straightness error component, the parallelism error component with respect to the spindle axis, can also be evaluated. The out-of-straightness error component and the parallelism error component of the slide error were measured to be 3.3 μm and 1.68 arc-seconds over a slide travel range of 1450.08 mm, respectively.

  4. 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

  5. 77 FR 52036 - Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Manager and Address FDA Research Integrity Officer, Office of the Chief Scientist, Food and Drug... Records Related to Research Misconduct Proceedings AGENCY: Food and Drug Administration, HHS. ACTION... Related to Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020. Under the Department...

  6. Top 100 bestselling drugs represent an arena struggling for new FDA approvals: drug age as an efficiency indicator.

    PubMed

    Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra

    2015-11-01

    We analyzed a list of the top 100 bestselling drugs as a struggling market for new FDA approvals. Using the time from drug approval by the FDA as a measure of drug age, our analysis showed that the top 100 bestselling drugs are getting older. This reflects the stalled launch of new drugs into the market during recent years. PMID:26160060

  7. 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....

  8. 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

  9. 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... Tobacco Dependence; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA)...

  10. 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.

  11. 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

  12. Geographic Variation in Rosiglitazone Use Surrounding FDA Warnings in the Department of Veterans Affairs

    PubMed Central

    Ahuja, Vishal; Sohn, Min-Woong; Birge, John R.; Syverson, Chad; Budiman-Mak, Elly; Emanuele, Nicholas; Cooper, Jennifer M.; Huang, Elbert S.

    2016-01-01

    BACKGROUND Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later. While large declines have been documented in rosiglitazone use in clinical practice, little is known about how the use of rosiglitazone and other glucose-lowering drugs varied within the Department of Veterans Affairs (VA), surrounding the FDA alerts. Understanding this variation within integrated health care systems is essential to formulating policies that enhance patient protection and quality of care. OBJECTIVE To document variation in the use of rosiglitazone and other glucose-lowering drugs across 21 Veterans Integrated Service Networks (VISNs). METHODS We conducted a retrospective analysis of drug use patterns for all major diabetes drugs in a national cohort of 550,550 veterans with diabetes from 2003 to 2008. This included the time periods when rosiglitazone was added to (November 2003) and removed from (October 2007) the VA national formulary (VANF). We employed multivariable logistic regression models to statistically estimate the association between a patient’s location and the patient’s odds of using rosiglitazone. RESULTS Aggregate rosiglitazone use increased monotonically from 7.7%, in the quarter it was added to the VANF (November 4, 2003), to a peak of 15.3% in the quarter when the FDA issued the safety alert. Rosiglitazone use decreased sharply afterwards, reaching 3.4% by the end of the study period (September 30, 2008). The use of pioglitazone, another glucose-lowering drug in the same class as rosiglitazone, was

  13. The crime of saving lives. The FDA, John Najarian, and Minnesota ALG.

    PubMed

    Wilson, L G

    1995-10-01

    The indictment of John Najarian, MD, and Richard Condie at Minneapolis, Minn, on April 10, 1995, was a defining episode in the prolonged agony that has ensued since August 1992, when the federal Food and Drug Administration (FDA) placed Minnesota Anti-Lymphocyte Globulin (MALG) on clinical hold, bringing to an end its use as an immunosuppressive agent for patients undergoing transplantation. The principal charge in the indictment is that from about 1968 until 1992--the whole period of the development and use of MALG--Dr Najarian and Mr Condie conspired to defraud the United States by impeding the FDA in its oversight of biological drugs and that they did so for the purpose of financial gain. If the charges can be considered seriously, they mean that Dr Najarian's purpose in the development and manufacture of MALG was to make money, presumably for himself, and that the possible benefit of MALG to the patients was of secondary concern to him. Several difficulties arise immediately. In 1968, MALG offered a promising new approach to immunosuppression. In a relatively crude form, it had been used at the University of Colorado with striking improvement in the survival of patients undergoing transplantation and transplanted organs, but it was painful to administer by intramuscular injections and, in addition to other side effects, produced muscular spasms. Dr Najarian and his colleagues succeeded in purifying MALG so that the pure globulin could be injected into a central vein. The process of purification was complicated and expensive, so it was hardly practical for each transplant center to produce MALG for itself. Thus, in 1969, when Dr Najarian submitted an investigational new drug application (IND) to the FDA, he stated that his purpose was to manufacture MALG not only for patients at the University of Minnesota Hospital but also for patients at other transplant centers, which were not in a position to make it for themselves. He asked the FDA to approve recovery of

  14. 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.

  15. 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…

  16. 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…

  17. Transistor h parameter conversion slide rule

    NASA Technical Reports Server (NTRS)

    Brantner, R. E.

    1967-01-01

    Slide rule enables the ready conversion of transistor h parameters from one form to another and reduces calculation time by a factor of 5 to 10. The scales are selected to cover all ranges of each parameter that will normally exist for any transistor, and answers are given in the correct order of magnitude, making powers-of-ten calculations unnecessary.

  18. Sliding, Insulating Window Panel Reduces Heat Loss.

    ERIC Educational Resources Information Center

    School Business Affairs, 1984

    1984-01-01

    A new sliding insulated panel reduces window heat loss up to 86 percent, and infiltration 60-90 percent, paying for itself in 3-9 years. This article discusses the panel's use and testing in the upper Midwest, reporting both technical characteristics and users' reactions. (MCG)

  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. 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…

  1. Solenoid valve design minimizes vibration and sliding wear problem

    NASA Technical Reports Server (NTRS)

    Gillon, W. A., Jr.

    1968-01-01

    Two-way cryogenic solenoid valve resists damage from vibration and metallic interfacial sliding. The new system features a flat-faced armature guided by a flexure disk which eliminates sliding surfaces and is less subject to contamination and wear.

  2. 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)

  3. From Peru to Pamplona: Integrating Slides into the Lesson Plan.

    ERIC Educational Resources Information Center

    Kiss, Marilyn

    1989-01-01

    For a visual generation of students, slides are an effective learning and teaching tool and a constant stimulus for writing, reading, and speaking activities. Ways in which slides have been effectively incorporated into foreign language instruction lessons are described. (CB)

  4. 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

  5. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Sliding fee scales. 98.42 Section 98.42 Public... Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall establish, and periodically revise, by rule, a sliding fee scale(s)...

  6. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Sliding fee scales. 98.42 Section 98.42 Public... Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall establish, and periodically revise, by rule, a sliding fee scale(s)...

  7. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Sliding fee scales. 98.42 Section 98.42 Public... Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall establish, and periodically revise, by rule, a sliding fee scale(s)...

  8. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Sliding fee scales. 98.42 Section 98.42 Public... Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall establish, and periodically revise, by rule, a sliding fee scale(s)...

  9. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Sliding fee scales. 98.42 Section 98.42 Public... Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall establish, and periodically revise, by rule, a sliding fee scale(s)...

  10. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Automated slide stainer. 864.3800 Section 864.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain...

  11. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Automated slide stainer. 864.3800 Section 864.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain...

  12. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated slide stainer. 864.3800 Section 864.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain...

  13. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automated slide stainer. 864.3800 Section 864.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain...

  14. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Automated slide stainer. 864.3800 Section 864.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain...

  15. 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

  16. Violations of exhibiting and FDA rules at an American Psychiatric Association annual meeting.

    PubMed

    Lurie, Peter; Tran, Tung; Wolfe, Sidney Manuel; Goodman, Robert

    2005-12-01

    We conducted a cross-sectional study of all exhibit booths for the 24 pharmaceutical companies at the 2002 American Psychiatric Association (APA) convention. We collected and categorized one of each item distributed by the companies at each booth. A total of 268 items were collected from 24 companies (median=8). The most common categories of items were "reprints or pamphlets" (37%) and "noneducational gifts" (27%), including music CDs and invitations to dinners and museums. There were a total of 16 violations of the APA's own exhibit rules: eight companies had one violation and two companies had four violations. Four companies engaged in FDA-prohibited off-label promotion; one also violated the APA code. Over half of all companies (54%) were in violation of either APA rules or FDA regulations. The APA's voluntary code has failed to adequately reduce inappropriate promotional activity at the annual APA meeting. PMID:16392738

  17. 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

  18. 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. PMID:20846933

  19. 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

  20. 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

  1. Gas bearings. [fluid lubrication theory of sliding contact surfaces

    NASA Technical Reports Server (NTRS)

    Pan, C. H. T.

    1980-01-01

    The present work deals with the fundamentals of gas lubrication theory, which forms the foundation of all analytical design tools for gas bearings. Most of the hard lessons learned in the past are outlined with reference to dry contact, debris ingestion, sliding speed, and chemical stability of lubricant. The mathematical theory of gas lubrication is described for scaling rules in thin-film viscous flow, momentum conservation, mass conservation, energy conservation, isothermal gas bearing theory, coupling effects, and global bearing characteristics. Particular attention is given to the governing differential equations for common bearing configurations. Also discussed are representative solutions of self-acting gas bearings, externally pressurized bearings, and time-dependent effects.

  2. 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.

  3. Biological systems drug infusion controller using FREN with sliding bounds.

    PubMed

    Chidentree, Treesatayapun; Sermsak, Uatrongjit

    2006-11-01

    In this paper, a direct adaptive control for drug infusion of biological systems is presented. The proposed controller is accomplished using our adaptive network called Fuzzy Rules Emulated Network (FREN). The structure of FREN resembles the human knowledge in the form of fuzzy IF-THEN rules. After selecting the initial value of network's parameters, an on-line adaptive process based on Lyapunov's criteria is performed to improve the controller performance. The control signal from FREN is designed to keep in the region which is calculated by the modified Sliding Mode Control (SMC). The simulation results indicate that the proposed algorithm can satisfy the setting point and the robust performance. PMID:17073348

  4. 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. PMID:26061899

  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. Permanent Magnet DC Motor Sliding Mode Control System

    NASA Astrophysics Data System (ADS)

    Vaez-Zadeh, S.; Zamanian, M.

    2000-09-01

    In this paper a sliding mode controller (SMC) is designed for a permanent magnet, direct current (PMDC) motor to enhance the motor performance in the presence of unwanted uncertainties. Both the electrical and mechanical signals are used as the inputs to the SMC. The complete motor control system is simulated on a personal computer with different design parameters and desirable system performance is obtained. The experimental implementation of the motor control system is also presented. The test results confirm the simulation results and validate the proposed control system.

  7. [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. PMID:20329620

  8. 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. |

  9. Numerical modelling of tsunami generation by deformable submarine slides using mesh adaptivity

    NASA Astrophysics Data System (ADS)

    Smith, Rebecca; Parkinson, Samuel; Hill, Jon; Collins, Gareth; Piggott, Matthew

    2014-05-01

    Tsunamis generated by submarine slides are often under considered in comparison to earthquake generated tsunami, despite several recent examples. Tsunamigenic slides have generated waves that have caused significant damage and loss of life, for example the 1998 Papua New Guinea submarine mass failure resulted in a tsunami that devastated coastal villages and killed over 2,100 people. Numerical simulations of submarine slide generated waves can help us understand the nature of the waves that are generated, and identify the important factors in determining wave characteristics. There have not been many studies of tsunami generation by deformable submarine slides, largely because of the complexities and computational expense involved in modelling these large scale events. At large, real world, scales modelling of tsunami waves by the generation of slides is computationally challenging. Fluidity is an open source finite element code that is ideally suited to tackle this type of problem as it uses unstructured, adaptive meshes, which help to reduce the computational expense without losing accuracy in the results. Adaptive meshes change topology and resolution based on the current simulation state and as such can focus or reduce resolution when and where it is required. The model also allows a number of different numerical approaches to be taken to simulate the same problem within the same numerical framework. In this example we use multi-material approach, with both two materials (slide and water) and three materials (slide, water and air), alongside a density-driven sediment model approach. We will present results of validating Fluidity against benchmarks from experimental and other numerical studies, at different scales, for deformable underwater slides, and consider the utility of mesh adaptivity. We show good agreement to both laboratory results and other numerical models, both with a fixed mesh and a dynamically adaptive mesh, tracking important features of the

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  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. PMID:15098585

  17. MPM dynamic simulation of a seismically induced sliding mass

    NASA Astrophysics Data System (ADS)

    Moormann, C.; Hamad, F.

    2015-09-01

    In some geotechnical applications, material can undergo large displacement combined with excessive deformation; e.g. the sliding mass problem. Owing to the limitations of classical Lagrangian and Eulerian finite element methods to model these problems, the Material Point Method (MPM) has been developed about two decades ago to cope with the large deformation. In MPM, the continuum field is represented by Lagrangian material points (particles), which can move through a fixed background of a computational mesh. Therefore, it can be seen as a mesh-based method formulated in arbitrary Lagrangian-Eulerian description. Although MPM represents the continuum by material points, solution is performed on the computational mesh. Thus, imposing boundary conditions is not aligned with the material representation. In this paper, a non-zero kinematic condition is introduced where an additional set of particles is incorporated, which tracks the moving boundary by carrying the time- dependent boundary evolution. Furthermore, the material point method has been adopted to simulate the progressive failure of a sliding granular slope triggered by a seismic excitation. In order to represent the topographical bottom of the sliding mass, on which the seismic motion is applied, a rigid boundary is implemented by introducing an additional set of particles. A frictional contact algorithm is defined between the boundary and the descending mass, which allows sliding and rolling with friction. The traction due to contact is incorporated into the discretised momentum equation as an external force where the solution of this equation is performed separately for each body in contact. Defining the local coordinate system accurately in this algorithm is essential to avoid interpenetration. Thus, a two-dimensional triangular discretisation is utilised within the three-dimensional tetrahedral elements to track the surface progression of each body in contact. Complying with other continuum models

  18. "PowerPoint": Just Another Slide Show or a Useful Learning Aid?

    ERIC Educational Resources Information Center

    Parkinson, John; Hollamby, Peter

    2003-01-01

    Extols the virtues of PowerPoint as a teaching aid yet cautions against inappropriate use of it which may cause students to learn very little. Explains a number of features of slide preparation and presentation techniques that enable teachers to give effective lessons. Includes examples of PowerPoint presentations. (Author/NB)

  19. A measure for characterizing sliding on lung boundaries.

    PubMed

    Amelon, Ryan E; Cao, Kunlin; Reinhardt, Joseph M; Christensen, Gary E; Raghavan, Madhavan L

    2014-03-01

    The lobes of the lung slide relative to each other during breathing. Quantifying lobar sliding can aid in better understanding lung function, better modeling of lung dynamics, and for studying phenomenon such as pleural adhesion. We propose a novel measure to characterize lobe sliding in the lung based on the displacement field obtained from image registration of CT scans. When two sliding lobes are modeled as a continuum, the discontinuity in the displacement field at the fissure will manifest as elevated maximum shear--the proposed measure--which is capable of capturing both the level and orientation of sliding. Six human lungs were analyzed using scans spanning functional residual capacity to total lung capacity. The lung lobes were segmented and registered on a lobe-by-lobe basis to obtain the displacement field from which the proposed sliding measure was calculated. The sliding measure was found to be insignificant in the parenchyma, as relatively little tissue shear occurs here. On the other hand, it was elevated along the fissures. Thus, a map of the proposed sliding measure of the entire lung clearly delineates and quantifies sliding between lung lobes. Sliding is a key aspect of lung deformation during breathing. The proposed measure may help resolve artifacts introduced by sliding in deformation analysis techniques used for radiotherapy. PMID:24114112

  20. 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

  1. 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.

  2. Fuzzy fractional order sliding mode controller for nonlinear systems

    NASA Astrophysics Data System (ADS)

    Delavari, H.; Ghaderi, R.; Ranjbar, A.; Momani, S.

    2010-04-01

    In this paper, an intelligent robust fractional surface sliding mode control for a nonlinear system is studied. At first a sliding PD surface is designed and then, a fractional form of these networks PDα, is proposed. Fast reaching velocity into the switching hyperplane in the hitting phase and little chattering phenomena in the sliding phase is desired. To reduce the chattering phenomenon in sliding mode control (SMC), a fuzzy logic controller is used to replace the discontinuity in the signum function at the reaching phase in the sliding mode control. For the problem of determining and optimizing the parameters of fuzzy sliding mode controller (FSMC), genetic algorithm (GA) is used. Finally, the performance and the significance of the controlled system two case studies (robot manipulator and coupled tanks) are investigated under variation in system parameters and also in presence of an external disturbance. The simulation results signify performance of genetic-based fuzzy fractional sliding mode controller.

  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. Terminal Sliding Modes In Nonlinear Control Systems

    NASA Technical Reports Server (NTRS)

    Venkataraman, Subramanian T.; Gulati, Sandeep

    1993-01-01

    Control systems of proposed type called "terminal controllers" offers increased precision and stability of robotic operations in presence of unknown and/or changing parameters. Systems include special computer hardware and software implementing novel control laws involving terminal sliding modes of motion: closed-loop combination of robot and terminal controller converge, in finite time, to point of stable equilibrium in abstract space of velocity and/or position coordinates applicable to particular control problem.

  5. Validation of diagnostic accuracy using digital slides in routine histopathology

    PubMed Central

    2012-01-01

    Background Robust hardware and software tools have been developed in digital microscopy during the past years for pathologists. Reports have been advocated the reliability of digital slides in routine diagnostics. We have designed a retrospective, comparative study to evaluate the scanning properties and digital slide based diagnostic accuracy. Methods 8 pathologists reevaluated 306 randomly selected cases from our archives. The slides were scanned with a 20× Plan-Apochromat objective, using a 3-chip Hitachi camera, resulting 0.465 μm/pixel resolution. Slide management was supported with dedicated Data Base and Viewer software tools. Pathologists used their office PCs for evaluation and reached the digital slides via intranet connection. The diagnostic coherency and uncertainty related to digital slides and scanning quality were analyzed. Results Good to excellent image quality of slides was recorded in 96%. In half of the critical 61 digital slides, poor image quality was related to section folds or floatings. In 88.2% of the studied cases the digital diagnoses were in full agreement with the consensus. Out of the overall 36 incoherent cases, 7 (2.3%) were graded relevant without any recorded uncertainty by the pathologist. Excluding the non-field specific cases from each pathologist's record this ratio was 1.76% of all cases. Conclusions Our results revealed that: 1) digital slide based histopathological diagnoses can be highly coherent with those using optical microscopy; 2) the competency of pathologists is a factor more important than the quality of digital slide; 3) poor digital slide quality do not endanger patient safety as these errors are recognizable by the pathologist and further actions for correction could be taken. Virtual slides The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1913324336747310. PMID:22463804

  6. 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.

  7. Robust supervised segmentation of neuropathology whole-slide microscopy images.

    PubMed

    Vandenberghe, Michel E; Balbastre, Yaël; Souedet, Nicolas; Hérard, Anne-Sophie; Dhenain, Marc; Frouin, Frédérique; Delzescaux, Thierry

    2015-08-01

    Alzheimer's disease is characterized by brain pathological aggregates such as Aβ plaques and neurofibrillary tangles which trigger neuroinflammation and participate to neuronal loss. Quantification of these pathological markers on histological sections is widely performed to study the disease and to evaluate new therapies. However, segmentation of neuropathology images presents difficulties inherent to histology (presence of debris, tissue folding, non-specific staining) as well as specific challenges (sparse staining, irregular shape of the lesions). Here, we present a supervised classification approach for the robust pixel-level classification of large neuropathology whole slide images. We propose a weighted form of Random Forest in order to fit nonlinear decision boundaries that take into account class imbalance. Both color and texture descriptors were used as predictors and model selection was performed via a leave-one-image-out cross-validation scheme. Our method showed superior results compared to the current state of the art method when applied to the segmentation of Aβ plaques and neurofibrillary tangles in a human brain sample. Furthermore, using parallel computing, our approach easily scales-up to large gigabyte-sized images. To show this, we segmented a whole brain histology dataset of a mouse model of Alzheimer's disease. This demonstrates our method relevance as a routine tool for whole slide microscopy images analysis in clinical and preclinical research settings. PMID:26737134

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. Sliding mode control of continuous time systems with reaching law based on exponential function

    NASA Astrophysics Data System (ADS)

    Gamorski, Piotr

    2015-11-01

    In this paper a pseudo-sliding mode control is proposed by introducing a continuous and smooth input signal in order to guarantee both chattering elimination and boundedness of sliding variable derivative in the presence of non-zero external disturbance. For this purpose, having fixed a suitable sliding manifold, a homogeneous differential equation describing the sliding variable evolution is considered. It is discussed later in this paper that the input signal formed on the basis of this equation provides asymptotic convergence of the sliding variable and its derivative to zero as well as the asymptotic stability of the non-linear system in the absence of external disturbance. The dynamics of the system affected by non-zero external disturbance make the state vector converge to domains in a vicinity of the origin at the exponential rate, as the norm of arbitrary trajectory is limited to decreasing exponential function. In order to expand the variety of controllers based on a reaching law and providing the above-mentioned properties, a certain class of functions is presented.

  14. Improving the visualization and detection of tissue folds in whole slide images through color enhancement

    PubMed Central

    Bautista, Pinky A.; Yagi, Yukako

    2010-01-01

    Objective: The objective of this paper is to improve the visualization and detection of tissue folds, which are prominent among tissue slides, from the pre-scan image of a whole slide image by introducing a color enhancement method that enables the differentiation between fold and non-fold image pixels. Method: The weighted difference between the color saturation and luminance of the image pixels is used as shifting factor to the original RGB color of the image. Results: Application of the enhancement method to hematoxylin and eosin (H&E) stained images improves the visualization of tissue folds regardless of the colorimetric variations in the images. Detection of tissue folds after application of the enhancement also improves but the presence of nuclei, which are also stained dark like the folds, was found to sometimes affect the detection accuracy. Conclusion: The presence of tissue artifacts could affect the quality of whole slide images, especially that whole slide scanners select the focus points from the pre-scan image wherein the artifacts are indistinguishable from real tissue area. We have a presented in this paper an enhancement scheme that improves the visualization and detection of tissue folds from pre-scan images. Since the method works on the simulated pre-scan images its integration to the actual whole slide imaging process should also be possible. PMID:21221170

  15. 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.

  16. 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.

  17. Projecting a Better Image: Slides and the Foreign Language Teacher. CAL-ERIC/CLL Series on Languages and Linguistics, No. 48.

    ERIC Educational Resources Information Center

    Galt, Alan

    This handbook demonstrates how to make and present travel slides for the language and culture course with maximum effectiveness. There are six basic rules for the teacher to follow: (1) fill the frame; (2) suppress your ego; keep yourself and your relatives out of your picture; (3) leave the audience wishing for more slides, not fewer; (4) vary…

  18. A new apparatus for multilayer growth by chemical vapor deposition: The sliding-boat close-spaced technique

    NASA Astrophysics Data System (ADS)

    Yoshikawa, Akihiko; Yoshihara, Seiji; Kasai, Haruo; Nishimaki, Masao

    1980-10-01

    A new apparatus for multilayer growth by chemical vapor deposition, the sliding-boat close-spaced tecnique (SBCST), is presented. The structure of the SBCST growth apparatus is quite similar to that of the conventional liquid phase epitaxy sliding-boat. The possibility of obtaining thin multilayer films by SBCST is shown. Preliminary experimental results for its application to the growth of n-CdS/p-InP heterojunction solar cells are also shown.

  19. Virtual slide mosaicing using feature descriptors and a registration consistency measure

    NASA Astrophysics Data System (ADS)

    Romo, David E.; Tarquino, Jonathan; García-Arteaga, Juan D.; Romero, Eduardo

    2013-11-01

    The advent of low-cost digital storage and automated microscope motor stages has made it possible to sequen- tially capture the full set of elds of view (FOV) covering a slide sample in a process commonly resulting in hundreds or even thousands of images. Aligning or verifying manually the alignment of thousands of images is an unrealistically labor intensive task that is, however, a fundamental step in the analysis of virtual-slides: For virtual-Slide creation the automation of the aligning process is not a mere an option but an absolute necessity. In the present work we propose the use of feature based methods and local consistency measures to improve the creation of mosaics from individual images captured with an in-house built microscope.

  20. Decoupled thermal control for space station furnace facility using sliding mode techniques

    NASA Astrophysics Data System (ADS)

    Jackson, Mark E.; Shtessel, Yuri B.

    1996-03-01

    The Space Station Furnace Facility (SSFF) provides the necessary core systems to operate various material processing furnaces. The Thermal Control System (TCS) is defined as one of the core systems and its function is to collect excess heat from furnaces and to provide precise cold temperature control of components and of certain furnace zones. Physical interconnection of parallel thermal control subsystems through a common pump implies the description of the whole TCS by coupled nonlinear differential equations in flow and pressure. The paper formulates the system equations and develops the sliding mode controllers that cause the interconnected subsystems to operate in the local sliding modes, resulting in control system invariance to interaction disturbances. The desired de-coupled flow rate profile tracking is achieved by optimization of the local linear sliding mode equations. Extensive digital simulation results are presented to show the flow rate tracking robustness and invariance to plant nonlinearities and variations of the pump pressure supplied to the controlled subsystems.

  1. A novel sliding window algorithm for 2D discrete Fourier transform

    NASA Astrophysics Data System (ADS)

    Dong, Zhifang; Wu, Jiasong; Gui, Jiyong

    2015-12-01

    Discrete Fourier transform (DFT) is one of the most wildly used tools for signal processing. In this paper, a novel sliding window algorithm is presented for fast computing 2D DFT when sliding window shifts more than one-point. The propose algorithm computing the DFT of the current window using that of the previous window. For fast computation, we take advantage of the recursive process of 2D SDFT and butterfly-based algorithm. So it can be directly applied to 2D signal processing. The theoretical analysis shows that the computational complexity is equal to 2D SDFT when one sample comes into current window. As well, the number of additions and multiplications of our proposed algorithm are less than those of 2D vector radix FFT when sliding window shifts mutiple-point.

  2. 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.

  3. Adaptive sliding mode control of tri-layer conjugated polymer actuators

    NASA Astrophysics Data System (ADS)

    Wang, Xiangjiang; Alici, Gursel; Nguyen, Chuc Huu

    2013-02-01

    This paper proposes an adaptive sliding mode control methodology to enhance the positioning ability of conducting polymer actuators typified by tri-layer conjugated polymer actuators. This is motivated by the search for an effective control strategy to command such actuators to a desired configuration in the presence of parametric uncertainties and unmodeled disturbances. After analyzing the stability of the adaptive sliding mode control system, experiments were conducted to demonstrate its satisfactory tracking ability, based on a series of experimental results. Implementation of the control law requires a valid model of the conducting polymer actuator and boundaries of the uncertainties and disturbances. Based on the theoretical and experimental results presented, the adaptive sliding mode control methodology is very attractive in the field of smart actuators which contain significant uncertainties and disturbances.

  4. 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.

  5. Two dimensional nanoscale reciprocating sliding contacts of textured surfaces

    NASA Astrophysics Data System (ADS)

    Tong, Ruiting; Liu, Geng; Liu, Tianxiang

    2016-05-01

    Detailed behaviors of nanoscale textured surfaces during the reciprocating sliding contacts are still unknown although they are widely used in mechanical components to improve tribological characteristics. The current research of sliding contacts of textured surfaces mainly focuses on the experimental studies, while the cost is too high. Molecular dynamics(MD) simulation is widely used in the studies of nanoscale single-pass sliding contacts, but the CPU cost of MD simulation is also too high to simulate the reciprocating sliding contacts. In this paper, employing multiscale method which couples molecular dynamics simulation and finite element method, two dimensional nanoscale reciprocating sliding contacts of textured surfaces are investigated. Four textured surfaces with different texture shapes are designed, and a rigid cylindrical tip is used to slide on these textured surfaces. For different textured surfaces, average potential energies and average friction forces of the corresponding sliding processes are analyzed. The analyzing results show that "running-in" stages are different for each texture, and steady friction processes are discovered for textured surfaces II, III and IV. Texture shape and sliding direction play important roles in reciprocating sliding contacts, which influence average friction forces greatly. This research can help to design textured surfaces to improve tribological behaviors in nanoscale reciprocating sliding contacts.

  6. Two dimensional nanoscale reciprocating sliding contacts of textured surfaces

    NASA Astrophysics Data System (ADS)

    Tong, Ruiting; Liu, Geng; Liu, Tianxiang

    2016-04-01

    Detailed behaviors of nanoscale textured surfaces during the reciprocating sliding contacts are still unknown although they are widely used in mechanical components to improve tribological characteristics. The current research of sliding contacts of textured surfaces mainly focuses on the experimental studies, while the cost is too high. Molecular dynamics(MD) simulation is widely used in the studies of nanoscale single-pass sliding contacts, but the CPU cost of MD simulation is also too high to simulate the reciprocating sliding contacts. In this paper, employing multiscale method which couples molecular dynamics simulation and finite element method, two dimensional nanoscale reciprocating sliding contacts of textured surfaces are investigated. Four textured surfaces with different texture shapes are designed, and a rigid cylindrical tip is used to slide on these textured surfaces. For different textured surfaces, average potential energies and average friction forces of the corresponding sliding processes are analyzed. The analyzing results show that "running-in" stages are different for each texture, and steady friction processes are discovered for textured surfaces II, III and IV. Texture shape and sliding direction play important roles in reciprocating sliding contacts, which influence average friction forces greatly. This research can help to design textured surfaces to improve tribological behaviors in nanoscale reciprocating sliding contacts.

  7. Let me entertain ... er ... teach you: gaining attention through the use of slide shows.

    PubMed

    Gigliotti, E

    1995-01-01

    The lecture method has been and continues to be the object of criticism. But, perhaps, it is not the lecture which should bear the brunt of the criticism, but rather the lecturer. All too often the audience is bored. This article examines several popular media currently used to enliven the lecture. Instructional design theory is used to discuss their limitations. The use of a self-assembled slide show, featuring novelty and humor, is advocated in order to assist the lecturer in gaining attention and, thereby, avoiding the boredom pitfall. Useful suggestions for developing a slide presentation are provided. PMID:7534318

  8. Unknown Input and Sensor Fault Estimation Using Sliding-Mode Observers

    SciTech Connect

    Kalsi, Karanjit; Hui, Stefen; Zak, Stanislaw

    2011-06-29

    Sliding-mode observers are used to construct unknown input estimators. Then, these unknown input estimators are combined with sensor fault estimation schemes into one architecture that employs two sliding-mode observers for simultaneously estimating the plant’s actuator faults (part of the unknown input) and detecting sensor faults. Closed form expressions are presented for the estimates of unknown inputs and sensor faults. A benchmark example of a controlled inverted pendulum system from the literature is utilized in the simulation study. The study shows that the observers analyzed in this paper generate good estimates of the unknown input and sensor faults signals in noisy environments for nonlinear plants.

  9. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.

    PubMed

    Davit, Barbara M; Kanfer, Isadore; Tsang, Yu Chung; Cardot, Jean-Michel

    2016-05-01

    The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs. Subsequently, the World Health Organization (WHO) and European Medicines Agency (EMA) published guidelines recommending how to obtain BCS biowaivers for BCS Class III drugs (high solubility, low permeability), in addition to Class I drugs. In 2015, the US-FDA became better harmonized with the EMA and WHO following publication of two guidances for industry outlining criteria for obtaining BCS biowaivers for both Class I and Class III drugs. A detailed review and comparison of the BCS Class I and Class III criteria currently recommended by the US-FDA, EMA, and WHO revealed good convergence of the three agencies with respect to BCS biowaiver criteria. The comparison also suggested that, by applying the most conservative of the three jurisdictional approaches, it should be possible for a sponsor to design the same set of BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach. PMID:26943914

  10. New Role for FDA-Approved Drugs in Combating Antibiotic-Resistant Bacteria.

    PubMed

    Andersson, Jourdan A; Fitts, Eric C; Kirtley, Michelle L; Ponnusamy, Duraisamy; Peniche, Alex G; Dann, Sara M; Motin, Vladimir L; Chauhan, Sadhana; Rosenzweig, Jason A; Sha, Jian; Chopra, Ashok K

    2016-06-01

    Antibiotic resistance in medically relevant bacterial pathogens, coupled with a paucity of novel antimicrobial discoveries, represents a pressing global crisis. Traditional drug discovery is an inefficient and costly process; however, systematic screening of Food and Drug Administration (FDA)-approved therapeutics for other indications in humans offers a rapid alternative approach. In this study, we screened a library of 780 FDA-approved drugs to identify molecules that rendered RAW 264.7 murine macrophages resistant to cytotoxicity induced by the highly virulent Yersinia pestis CO92 strain. Of these compounds, we identified 94 not classified as antibiotics as being effective at preventing Y. pestis-induced cytotoxicity. A total of 17 prioritized drugs, based on efficacy in in vitro screens, were chosen for further evaluation in a murine model of pneumonic plague to delineate if in vitro efficacy could be translated in vivo Three drugs, doxapram (DXP), amoxapine (AXPN), and trifluoperazine (TFP), increased animal survivability despite not exhibiting any direct bacteriostatic or bactericidal effect on Y. pestis and having no modulating effect on crucial Y. pestis virulence factors. These findings suggested that DXP, AXPN, and TFP may modulate host cell pathways necessary for disease pathogenesis. Finally, to further assess the broad applicability of drugs identified from in vitro screens, the therapeutic potential of TFP, the most efficacious drug in vivo, was evaluated in murine models of Salmonella enterica serovar Typhimurium and Clostridium difficile infections. In both models, TFP treatment resulted in increased survivability of infected animals. Taken together, these results demonstrate the broad applicability and potential use of nonantibiotic FDA-approved drugs to combat respiratory and gastrointestinal bacterial pathogens. PMID:27067323

  11. Sliding Seal Materials for Adiabatic Engines, Phase 2

    NASA Technical Reports Server (NTRS)

    Lankford, J.; Wei, W.

    1986-01-01

    An essential task in the development of the heavy-duty adiabatic diesel engine is identification and improvements of reliable, low-friction piston seal materials. In the present study, the sliding friction coefficients and wear rates of promising carbide, oxide, and nitride materials were measured under temperature, environmental, velocity, and loading conditions that are representative of the adiabatic engine environment. In addition, silicon nitride and partially stabilized zirconia disks were ion implanted with TiNi, Ni, Co, and Cr, and subsequently run against carbide pins, with the objective of producing reduced friction via solid lubrication at elevated temperature. In order to provide guidance needed to improve materials for this application, the program stressed fundamental understanding of the mechanisms involved in friction and wear. Electron microscopy was used to elucidate the micromechanisms of wear following wear testing, and Auger electron spectroscopy was used to evaluate interface/environment interactions which seemed to be important in the friction and wear process. Unmodified ceramic sliding couples were characterized at all temperatures by friction coefficients of 0.24 and above. The coefficient at 800 C in an oxidizing environment was reduced to below 0.1, for certain material combinations, by the ion implanation of TiNi or Co. This beneficial effect was found to derive from lubricious Ti, Ni, and Co oxides.

  12. Clinical applications of slide-based cytometry (SBC)

    NASA Astrophysics Data System (ADS)

    Taernok, Attila; Gerstner, Andreas O. H.

    2003-07-01

    Slide-based cytometry (SBC) is a promising new development in clinical diagnostics. The Laser Scanning Cytometer (LSC) was the first such system that became commercially available. Over the years methods have been developed that can be applied in a broad variety of clinical diagnostic settings. The principle of SBC is that fluorochrome labeled specimens are immobilized on microscopic slides which are placed on a conventional epi-fluorescence microscope. Specimens are analyzed by one or two lasers. Data comparable to flow cytometry are generated. But in addition, the position of each individual event is recorded, a feature that allows to re-localize and to visualize each event that has been measured. The major advantage of LSC compared with other cytometric methods is the combination of two features: a) the minimal clinical sample volume needed, and b) the connection of fluorescence data and morphological information about the measured event. We have developed and will present examples of different techniques for application in clinical diagnosis: (1) Immunophenotyping using up to six different fluorochromes at a time, (2) analysis of minimal sample volumes using fine needle aspirate biopsies, and (3) analysis of cells in tissue sections. With these assays and assays developed by others, SBC has proven its wide spectrum of clinical applicability and can be introduced as a standard technology for multiple clinical settings.

  13. Denuded Zones, Diffusional Creep, and Grain Boundary Sliding

    SciTech Connect

    Wadsworth, J; Ruano, O A; Sherby, O D

    2001-06-27

    The appearance of denuded zones following low stress creep in particle-containing crystalline materials is both a microstructural prediction and observation often cited as irrefutable evidence for the Nabarro-Herring mechanism of diffusional creep. The denuded zones are predicted to be at grain boundaries that are orthogonal to the direction of the applied stress. Furthermore, their dimensions should account for the accumulated plastic flow. In the present paper, the evidence for such denuded zones is critically examined. These zones have been observed during creep of magnesium, aluminum, and nickel-base alloys. The investigation casts serious doubts on the apparently compelling evidence for the link between denuded zones and diffusional creep. Specifically, denuded zones are clearly observed under conditions that are explicitly not diffusional creep. Additionally, the denuded zones are often found in directions that are not orthogonal to the applied stress. Other mechanisms that can account for the observations of denuded zones are discussed. It is proposed that grain boundary sliding accommodated by slip is the rate-controlling process in the stress range where denuded zones have been observed. It is likely that the denuded zones are created by dissolution of precipitates at grain boundaries that are simultaneously sliding and migrating during creep.

  14. Buckling of a Flexible Strip Sliding on a Frictional Base

    NASA Astrophysics Data System (ADS)

    Huynen, Alexandre; Marck, Julien; Denoel, Vincent; Detournay, Emmanuel

    2013-03-01

    The main motivation for this contribution is the buckling of a drillstring sliding on the bottom of the horizontal section of borehole. The open questions that remain today are related to the determination of the onset of instability, and to the conditions under which different modes of constrained buckling occur. In this presentation, we are concerned by a two-dimensional version of this problem; namely, the sliding of a flexible strip being fed inside a conduit. The ribbon, which has a flexural rigidity EI and a weight per unit length w, is treated as an inextensible elastica of negligible thickness. The contact between the ribbon and the wall of the conduit is characterized by a friction coefficient μ. First, we report the result of a stability analysis that aims at determining the critical inserted length of the ribbon l* (μ) (scaled by the characteristic length λ =(EI / w) 1 / 3) at which there is separation between the strip and the conduit bottom, as well as the buckling mode. Next, the relationship between the feeding force F and the inserted length l after bifurcation is computed. Finally, the results of a ``kitchen table'' experiment involving a strip of silicon rubber being pushed on a plank are reported and compared with predictions.

  15. Compensation of significant parametric uncertainties using sliding mode online learning

    NASA Astrophysics Data System (ADS)

    Schnetter, Philipp; Kruger, Thomas

    An augmented nonlinear inverse dynamics (NID) flight control strategy using sliding mode online learning for a small unmanned aircraft system (UAS) is presented. Because parameter identification for this class of aircraft often is not valid throughout the complete flight envelope, aerodynamic parameters used for model based control strategies may show significant deviations. For the concept of feedback linearization this leads to inversion errors that in combination with the distinctive susceptibility of small UAS towards atmospheric turbulence pose a demanding control task for these systems. In this work an adaptive flight control strategy using feedforward neural networks for counteracting such nonlinear effects is augmented with the concept of sliding mode control (SMC). SMC-learning is derived from variable structure theory. It considers a neural network and its training as a control problem. It is shown that by the dynamic calculation of the learning rates, stability can be guaranteed and thus increase the robustness against external disturbances and system failures. With the resulting higher speed of convergence a wide range of simultaneously occurring disturbances can be compensated. The SMC-based flight controller is tested and compared to the standard gradient descent (GD) backpropagation algorithm under the influence of significant model uncertainties and system failures.

  16. FDA advisory committees meet January 26 on Salk HIV-1 immunogen.

    PubMed

    1995-01-01

    Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment. PMID:11362184

  17. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Cancer.gov

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  18. Statistical innovations in the medical device world sparked by the FDA.

    PubMed

    Campbell, Gregory; Yue, Lilly Q

    2016-01-01

    The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies. PMID:26372890

  19. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Cancer.gov

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  20. Measure Twice, Build Once: Bench-Scale Testing to Evaluate Bioretention Media Design - slides

    EPA Science Inventory

    The oral presentation will be at the EWRI International LID Conference in San Francisco, on April 11-14, 2010. The slides discuss the utility of conducting bench-scale testing on selected bioretention media and media amendments to validate hydrologic properties before installing...