Science.gov

Sample records for fda presentation slides

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

    ERIC Educational Resources Information Center

    Van Buren, Maurie

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

  2. Web-Based Slide Presentations.

    ERIC Educational Resources Information Center

    Just, Melissa L.

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

  3. 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…

  4. 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…

  5. 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 ...

  6. 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…

  7. FDA Terminology

    Cancer.gov

    Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7), an international medical standards organization, and used by FDA to exchange medication information. The SPL standard specifies use of some 30 sets of controlled terminology.

  8. SYNCHRONIZATION OF PRESENTATION SLIDES AND LECTURE VIDEOS USING BIT RATE SEQUENCES

    E-print Network

    Girod, Bernd

    frames of the lecture recordings allows us to enhance the user experience in multiple ways. FirstSYNCHRONIZATION OF PRESENTATION SLIDES AND LECTURE VIDEOS USING BIT RATE SEQUENCES G. Schroth1 , N The temporal synchronization of presentation slides and lecture videos enables us to enhance the user

  9. Submarine Landslide Morphology of Box Slides Present on the Continental Slope Offshore Fraser Island, Queensland, Australia

    NASA Astrophysics Data System (ADS)

    Fletcher, M. J. A.; Hubble, T.; Clarke, S. L.; Airey, D.; Yu, P. W. C.

    2014-12-01

    The Fraser Island slide complex is located on eastern Australia's continental slope. Two potentially tsunamigenic submarine landslides identified here as the 'North Fraser Island Upper Slope Slide' (25km2 in area, 100m thick) and the 'Middle Fraser Island Middle Slope Slide' (12km2 in area, 50m thick) are described. Morphologic, sedimentologic and geomechanical properties for these slides are compared to data reported for existing submarine landslides located to the south in New South Wales (NSW). The two Fraser Island slides are translational, box-shaped, slab slides. We suspect that the slabs remained intact during downslope transport. The upper slope slide is situated at a water depth of approximately 750m at the northern end of the Fraser Canyon complex. The head of this slide has apparently detached from a structural surface comprised of a Miocene reef complex located beneath the continental shelf edge. The middle slope slide is situated on a large plateau to the south of the Fraser Canyon complex in 1500m of water. Cores taken in the continental slope within both slides are long and present hemipelagic muds. Cores taken adjacent to both slides are short and terminate in stiff muds of suspected Miocene or Pliocene age. Additionally, the core adjacent to the upper slope slide presents a near surface layer of upper-fining of coarse to fine shelly sand which we interpret to be a turbidite deposit. This layer was deposited above hemipelagic muds which are ubiquitously present on the upper eastern Australian continental slope in NSW and Southern Queensland.

  10. 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…

  11. FDA Kids' Home Page

    MedlinePLUS

    ... Food & Drug Administration A to Z Index Follow FDA En Español Enter Search terms Home Food Drugs ... Instructions for Downloading Viewers and Players . Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site ...

  12. 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.

  13. FDA Certified Mammography Facilities

    MedlinePLUS

    ... Program Consumer Information (MQSA) Search for a Certified Facility Share Tweet Linkedin Pin it More sharing options ... Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on Search ...

  14. FDA 101: Dietary Supplements

    MedlinePLUS

    ... Commission. Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include ... selling these products. It is not legal to market a dietary supplement product as a treatment or ...

  15. FDA -- Electronic Submission Process

    Cancer.gov

    Food and Drug Administration – E lectronic Submission Process Stephen E. Wilson, DrPH (Biostatistics) Deputy Direct or Division of Biometrics II, CDER, FDA Member, CDER Electronic Submissions Working Group NIH Cancer Imaging Informatics Workshop Bethesda

  16. Text and slides of presentation originally presented to the Nova Scotia Utility and Review Board regarding the province's Demand Side Management program,19 April 2010.

    E-print Network

    Hughes, Larry

    Text and slides of presentation originally presented to the Nova Scotia Utility and Review Board regarding the province's Demand Side Management program,19 April 2010. ERG/201003 Nova Scotia's Demand Side of Electrical and Computer Engineering Dalhousie University http://lh.ece.dal.ca/enen 19 April 2010 #12;Nova

  17. 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…

  18. 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.

  19. FDA 101: Regulating Biological Products

    MedlinePLUS

    ... Home For Consumers Consumer Updates FDA 101: Regulating Biological Products Share Tweet Linkedin Pin it More sharing ... and highly important field. back to top What biological products does FDA regulate? The Center for Biologics ...

  20. Is It Really FDA Approved?

    MedlinePLUS

    ... purposes. back to top FDA does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients do not require FDA approval ...

  1. 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…

  2. FDA Approval: Blinatumomab.

    PubMed

    Przepiorka, Donna; Ko, Chia-Wen; Deisseroth, Albert; Yancey, Carolyn L; Candau-Chacon, Reyes; Chiu, Haw-Jyh; Gehrke, Brenda J; Gomez-Broughton, Candace; Kane, Robert C; Kirshner, Susan; Mehrotra, Nitin; Ricks, Tiffany K; Schmiel, Deborah; Song, Pengfei; Zhao, Ping; Zhou, Qing; Farrell, Ann T; Pazdur, Richard

    2015-09-15

    On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukemia (R/R ALL). Blinatumomab is a recombinant murine protein that acts as a bispecific CD19-directed CD3 T-cell engager. The basis for the approval was a single-arm trial with 185 evaluable adults with R/R ALL. The complete remission (CR) rate was 32% [95% confidence interval (CI), 26%-40%], and the median duration of response was 6.7 months. A minimal residual disease response was achieved by 31% (95% CI, 25%-39%) of all patients. Cytokine release syndrome and neurologic events were serious toxicities that occurred. Other common (>20%) adverse reactions were pyrexia, headache, edema, febrile neutropenia, nausea, tremor, and rash. Neutropenia, thrombocytopenia, and elevated transaminases were the most common (>10%) laboratory abnormalities related to blinatumomab. A randomized trial is required in order to confirm clinical benefit. Clin Cancer Res; 21(18); 4035-9. ©2015 AACR. PMID:26374073

  3. FDA crackdown on illegal products.

    PubMed

    2004-01-01

    During 2003, the Food and Drug Administration took significant strides to address the growing threat of illegal drugs and false health claims related to dietary supplements. "Our major priority is to continue fostering the legitimate manufacture, sale and use of FDA-regulated products while maintaining a zero-tolerance approach to illegal practices," says John Taylor, the FDA's associate commissioner for regulatory affairs. "We're working to allocate resources in a way that maximizes our impact on public health." PMID:15101364

  4. 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…

  5. 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…

  6. 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

    ...OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the...

  7. FDA's Standards for High Quality Foods

    MedlinePLUS

    ... what you pick from a box of assorted chocolates, you can be assured that FDA standards ensure ... defense of a new cause: the quality of chocolate. "Hands off my chocolate, FDA!" read one headline. ...

  8. 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)

  9. 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......

  10. The sawtooth cover slide

    NASA Technical Reports Server (NTRS)

    Meulenberg, A., Jr.

    1977-01-01

    A novel cover slide is reported which increases solar cell output by reducing the reflection of light from the cover slide surface and by redirecting incident light so that none falls on the collection grids of the cell. The new cover slide is fabricated with a sawtooth surface having a periodicity equal to that of the solar cell grids. This configuration refracts the light so that it is directed onto the semiconductor surface between the grid lines. Conventional grid patterns obstruct 7-10 percent of the light incident on the cell; at least half of this loss has been recovered by using the sawtooth cover slide. In addition, surface reflection from the conventional coated cover slide is suppressed by presenting a second surface to any light reflected at the first plane of contact. This double reflection results in a greater reduction of the reflection loss from the cover slide than does an antireflection coating on a flat surface.

  11. 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. PMID:4634511

  12. Slide 1

    Cancer.gov

    Design Parameters NCI National Clinical Trials Network 5 NCI National Clinical Trials Network 1. Tissue block (preferred) or at least 12 (4-5) -micron unstained slides (20 slides are strongly recommended).

  13. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 2010-10-01 2010-10-01 false FDA categorization of investigational devices...to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved...

  14. 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

    ...SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA...

  15. A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.

    PubMed

    Keatley, K L

    1999-01-01

    Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm. PMID:10992873

  16. 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

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring...Improvement of Tracking and Tracing of Food; Request for Comments and for...

  17. FDA’s Role in Standards Development

    Cancer.gov

    Rationale behind the Vision 1. Addresses the FDA’s Performance Plan 2. Optimizes FDA and manufacturer’s resources 3. Accomplishes International Trade Commitment 4. Strengthens cooperation between governments 5. Partners with manufacturers to reduce risks 6. Enables productivity improvements 7.

  18. 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…

  19. Slide system for machine tools

    DOEpatents

    Douglass, Spivey S. (Oak Ridge, TN); Green, Walter L. (Knoxville, TN)

    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.

  20. 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.

  1. Slide system for machine tools

    SciTech Connect

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

    1982-08-10

    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 highspeed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

  2. 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

    ... 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing the availability... Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings... Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings.''...

  3. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...1 2010-07-01 2010-07-01 false Other FDA closures and restrictions. 13.980 Section 13...National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent...

  5. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60...RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a petition filed under §...

  6. Slide 1

    Cancer.gov

    Phase 0 trials can start earlier than Phase 1 Conceived under FDA’s “Critical Path” initiative to help sponsors identify promising candidate drugs more quickly Toxicology evaluation less extensive than for traditional IND because of reduced dosing and limited exposure.

  7. FDA Approves First Therapeutic Cancer Vaccine

    Cancer.gov

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  8. FDA Warns About Stem Cell Claims

    MedlinePLUS

    ... are stem cells? How are they regulated? Health Fraud Scams Related Consumer Updates Adult Stem Cell Research Shows Promise Don't Be Fooled By Health Fraud Scams FDA 101: Health Fraud Awareness Cord Blood: ...

  9. FDA Finalizes New Food Safety Rules

    MedlinePLUS

    ... gov/medlineplus/news/fullstory_155711.html FDA Finalizes New Food Safety Rules Farms, importers will be responsible ... U.S. Food and Drug Administration on Friday finalized new rules to help keep contaminated food out of ...

  10. 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 ...

  11. FDA Approves Repatha for High Cholesterol

    MedlinePLUS

    ... fullstory_154375.html FDA Approves Repatha for High Cholesterol A leading cause of heart disease To use ... drug in its class approved to treat high cholesterol. The injected drug, among a new class called ...

  12. FDA Approves Expanded Use for Melanoma Drug

    MedlinePLUS

    ... which the cancer has reached one or more lymph nodes. Patients with this stage of melanoma typically ... surgery to remove melanoma skin tumors and nearby lymph nodes, according to an FDA news release. Melanoma ...

  13. 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

    ...SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049...for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory...

  14. FDA approved drugs as potential Ebola treatments

    PubMed Central

    Ekins, Sean; Coffee, Megan

    2015-01-01

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

  15. FDA Approves New Treatment for Lung Cancer

    MedlinePLUS

    ... medlineplus/news/fullstory_154946.html FDA Approves New Treatment for Lung Cancer Keytruda shrank tumors in some patients with advanced ... be used to treat advanced non-small cell lung cancer in patients whose disease has progressed after previous treatments and who have tumors that express a protein ...

  16. Evaluating eating behavior treatments by FDA standards.

    PubMed

    Tomiyama, A Janet; Ahlstrom, Britt; Mann, Traci

    2014-01-01

    Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require patients' time and investment, and may have risks. The Food and Drug Administration (FDA) has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1) Is the treatment safe? (2) How dangerous is the condition the intervention is treating? (3) Is the treatment effective? (4) Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine. PMID:24427153

  17. Evaluating eating behavior treatments by FDA standards

    PubMed Central

    Tomiyama, A. Janet; Ahlstrom, Britt; Mann, Traci

    2014-01-01

    Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require patients’ time and investment, and may have risks. The Food and Drug Administration (FDA) has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1) Is the treatment safe? (2) How dangerous is the condition the intervention is treating? (3) Is the treatment effective? (4) Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine. PMID:24427153

  18. 5 Ways New FDA Rules Will Make Your Food Safer

    MedlinePLUS

    ... Consumers Home For Consumers Consumer Updates 5 Ways New FDA Rules Will Make Your Foods Safer Share ... you and your family be protected by the new actions the Food and Drug Administration (FDA) is ...

  19. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section...Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not...part of an investigation until an IRB and FDA have both approved the application...

  20. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false FDA access to records. 806.30 Section...REMOVALS Reports and Records § 806.30 FDA access to records. Each device manufacturer...request of an officer or employee designated by FDA and under section 704(e) of the...

  1. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section...Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of...

  2. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false FDA assistance on eligibility. 60.10 ...RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon...the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and...

  3. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  4. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  5. 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...

  6. 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...

  7. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives...

  8. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false Communications between FDA and applicants...APPROVAL TO MARKET A NEW DRUG FDA Action...Applications § 314.102 Communications between FDA and applicants...elapsed. Such early communication would not ordinarily...applications for all new chemical entities...

  9. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...2011-04-01 false Communications between FDA and applicants...APPROVAL TO MARKET A NEW DRUG FDA Action...Applications § 314.102 Communications between FDA and applicants...elapsed. Such early communication would not ordinarily...applications for all new chemical entities...

  10. 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.

  11. 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.

  12. Meeting the FDA's Initiative for Protecting the US Drug Supply

    E-print Network

    Brock, David

    . To achieve these goals for the public good, the Food and Drug Administration (FDA) and individual States role of RFID technology in the prevention of counterfeit medicines (Mathews 2004). The report outlined for implementation of RFID based technologies to accomplish these tasks. Previously, Mark B. McClellan, FDA

  13. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food 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...

  14. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA access to records. 806.30 Section 806.30 Food 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...

  15. Effective Presentation Michael J. Quinn

    E-print Network

    Tullos, Desiree

    Effective Presentation Techniques Michael J. Quinn 7 October 2005 Version1.2 #12;Outline Structuring presentation Designing slides Pausing techniques Answering questions #12;Structuring presentation Designing slides Pausing techniques Answering questions #12;Structuring Presentation Planning Delivery

  16. 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.

  17. 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.

  18. Modeling the Sliding/Falling Ladder Paradox

    ERIC Educational Resources Information Center

    Fox, William P.; Fox, James B.

    2003-01-01

    Recently we were presented with an interesting twist to the sliding ladder problem viewed in the related rates section of most calculus textbooks. Our problem concerning a sliding ladder that eventually hits the ground. At first, those attempting this problem fell into the calculus trap using only related rates. Previous work for this problem…

  19. Slide 1

    Cancer.gov

    John E. Niederhuber, M.D. Presentation to the National Cancer Advisory Board September 6, 2006 NCI Community-Based Cancer Centers Pilot Program 61 major academic and research institutes making significant contributions

  20. Slide 1

    Cancer.gov

    HMO Cancer Research Network (CRN) Research Resource Concept Rachel Ballard-Barbash, MD, MPH Martin Brown, PhD (CRN Program Director) NCI Board of Scientific Advisors June 20, 2011 Presentation Outline • Need for National Research Resource • Unique

  1. Slide 1

    Cancer.gov

    1 Using Social Media to Understand and Address Substance Use and Addiction Trans-NIH RFA Concept presentation to NCI Board of Scientific Advisors Wen-ying Sylvia Chou, PhD, MPH Health Communication and Informatics Research Branch November 7,

  2. Discrepancies in the primary PLATO trial publication and the FDA reviews.

    PubMed

    Serebruany, Victor L

    2014-03-01

    The results of major indication seeking Phase 3 clinical trials are reported at international meetings, and simultaneously published In top medical journals. However, the data presented during such dual release do not disclose all the trial findings, suffer from overoptimistic interpretations heavily favoring the study sponsor. Ironically, after the New Drug Application is submitted for regulatory approval, and when the FDA secondary reviews become available for public, the benefit/risk assessment of a new drug is usually considered much less impressive. However, the community may ignore pivotal unreported findings later outlined in the government documents taking for granted the facts presented in the primary publication. The discrepancies between initial publication and the FDA files are not only confusing to the readership, but hold additional risks for patients. Indeed, if physicians are impressed with the initial interpretation of the trial, and do not have broad access to the FDA verified facts, chances are new agents will be prescribed based on exaggerated benefit and less safety concerns. The current pattern also hurts the reputation of the journal publishers, editors and reviewers challenging their trust and credibility. We here outline the disparity between the primary PLATO trial publication in the New England Journal of Medicine against the FDA verified numbers, and discuss how to avoid such mismatches in the future. PMID:24456868

  3. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] FDA Transparency Initiative: Improving Transparency to...Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report...

  4. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ...Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic...SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  5. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false Will FDA assign me a registration number? 1271.27...Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent...

  6. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false FDA action on a premarket notification. 807...Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order...

  7. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...2010-01-01 2010-01-01 false FDA, other Federal, and State requirements...MATERIAL General Information § 35.7 FDA, other Federal, and State requirements...the licensee from complying with applicable FDA, other Federal, and State...

  8. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false What information must FDA include in the detention order? 1.393...for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order?...

  9. Factors influencing the time for FDA review of medical devices

    E-print Network

    Singh, Inder Raj, S.M. Massachusetts Institute of Technology

    2007-01-01

    Companies must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application ...

  10. NIH-FDA Interagency Clinical Outcome Assessments Working Group

    Cancer.gov

    To increase communication between the relevant groups at FDA and the many separate efforts at NIH to advance measurement science by exchanging information about specific COA projects of common interest, thereby improving the knowledge base for COA development.

  11. Kids Drawn to 'Gateway' Flavored Tobacco Products, FDA Finds

    MedlinePLUS

    ... nlm.nih.gov/medlineplus/news/fullstory_155350.html Kids Drawn to 'Gateway' Flavored Tobacco Products, FDA Finds ... addicts, a new U.S. government study finds. Among kids aged 12 to 17 who had used tobacco, ...

  12. FDA Approves New Drug for Schizophrenia, Bipolar Disorder

    MedlinePLUS

    ... gov/medlineplus/news/fullstory_154708.html FDA Approves New Drug for Schizophrenia, Bipolar Disorder Vraylar is an ... 2015 FRIDAY, Sept. 18, 2015 (HealthDay News) -- A new antipsychotic drug to treat schizophrenia and bipolar disorder ...

  13. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET...appropriate to discuss the particular issue at hand. Communications shall be appropriately...

  14. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET...appropriate to discuss the particular issue at hand. Communications shall be appropriately...

  15. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET...appropriate to discuss the particular issue at hand. Communications shall be appropriately...

  16. Developing Orphan Products: FDA and Rare Disease Day

    MedlinePLUS

    ... to bring devices for rare diseases to the market through a two-step process. The first step ... Device. The second step is FDA approval to market the device under the Humanitarian Device Exemption (HDE) ...

  17. Illnesses, Deaths Spur FDA Warning on Hepatitis C Drugs

    MedlinePLUS

    ... html Illnesses, Deaths Spur FDA Warning on Hepatitis C Drugs Cautionary label will be added to Viekira ... on two drugs used to fight the hepatitis C virus. The drugs, called Viekira Pak and Technivie, ...

  18. La FDA aprueba primera vacuna terapéutica contra el cáncer

    Cancer.gov

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  19. Sliding mode control of quantum systems

    E-print Network

    Daoyi Dong; Ian R. Petersen

    2009-10-31

    This paper proposes a new robust control method for quantum systems with uncertainties involving sliding mode control (SMC). Sliding mode control is a widely used approach in classical control theory and industrial applications. We show that SMC is also a useful method for robust control of quantum systems. In this paper, we define two specific classes of sliding modes (i.e., eigenstates and state subspaces) and propose two novel methods combining unitary control and periodic projective measurements for the design of quantum sliding mode control systems. Two examples including a two-level system and a three-level system are presented to demonstrate the proposed SMC method. One of main features of the proposed method is that the designed control laws can guarantee desired control performance in the presence of uncertainties in the system Hamiltonian. This sliding mode control approach provides a useful control theoretic tool for robust quantum information processing with uncertainties.

  20. 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.

  1. 8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

    PubMed

    Bower, Joseph; Fast, Douglas; Garofolo, Fabio; Gouty, Dominique; Hayes, Roger; Lowes, Steve; Nicholson, Robert; LeLacheur, Richard; Bravo, Jennifer; Shoup, Ronald; Dumont, Isabelle; Carbone, Mary; Zimmer, Jennifer; Ortuno, Jordi; Caturla, Maria Cruz; Datin, Jim; Lansing, Tim; Fatmi, Saadya; Struwe, Petra; Sheldon, Curtis; Islam, Rafiqul; Yu, Mathilde; Hulse, Jim; Kamerud, John; Lin, John; Doughty, John; Kurylak, Kai; Tang, Daniel; Buonarati, Mike; Blanchette, Alexandre; Levesque, Ann; Gagnon-Carignan, Sofi; Lin, Jenny; Ray, Gene; Liu, Yanseng; Khan, Masood; Xu, Allan; El-Sulayman, Gibran; DiMarco, Chantal; Bouhajib, Mohammed; Tacey, Dick; Jenkins, Rand; der Strate, Barry van; Briscoe, Chad; Karnik, Shane; Rhyne, Paul; Garofolo, Wei; Schultz, Gary; Roberts, Andrew; Redrup, Mike; DuBey, Ira; Conliffe, Phyllis; Pekol, Teri; Hantash, Jamil; Cojocaru, Laura; Allen, Mike; Reuschel, Scott; Watson, Andrea; Farrell, Colin; Groeber, Elizabeth; Malone, Michele; Nowatzke, William; Fang, Xinping

    2014-01-01

    The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA. PMID:25496252

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

    NASA Astrophysics Data System (ADS)

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

    2014-07-01

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

  3. 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

  4. 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

  5. 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

  6. 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...

  7. Impact of PK/PD, Disease Models and Personalized Medicine to Influence FDA Decisions

    E-print Network

    Powell, Robert

    2006-10-26

    Models and Personalized Medicine to Influence FDA Decisions Bob Powell, Pharm.D. Pharmacometrics Offices of Clinical Pharmacology & Translational Sciences Center for Drug Evaluation & Research FDA robert.powell@fda.hhs Declining Morbidity and Mortality... ? Personalized medicine Outline ? How FDA makes decisions ? High attrition, high cost, low productivity ? Model based drug development ? Disease models ? Modeling & simulation ? People development Drug Development & Regulator Process Overview...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities.'' The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is......

  9. 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

    ... foreign food and animal feed firms in the supply chain from farm to U.S. table. In particular, title III... 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 New Paradigm...

  10. 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

  11. Semantic focusing allows fully automated single-layer slide scanning of cervical cytology slides.

    PubMed

    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

  12. Medical devices, the FDA, and the home healthcare clinician.

    PubMed

    Simone, Lisa K; Brumbaugh, JoAnn; Ricketts, Catherine

    2014-01-01

    This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medical devices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medical device problems that may be unique to these environments. PMID:24978574

  13. Slides of the Math Advisors Presentation

    E-print Network

    sdunderm

    2013-10-24

    Oct 24, 2013 ... Classics; Sociology; Anthropology; Interdisciplinary Studies ... Great Issues combine science, technology, economics, social impact, and look at a current issue facing ... French, German, Japanese, Latin, Russian, and Spanish.

  14. Diagnosing nephrogenic systemic fibrosis in the post-FDA restriction era.

    PubMed

    Thomson, Laura K; Thomson, Peter C; Kingsmore, David B; Blessing, Karen; Daly, Conal D; Cowper, Shawn E; Roditi, Giles H

    2015-05-01

    The emergence of an association between gadolinium-based contrast agents (GBCA) and the rare condition nephrogenic systemic fibrosis (NSF) led to a warning in 2006 from the Food and Drug Administration (FDA) restricting the use of the GBCAs to patients with an estimated glomerular filtration rate of >30 mL/min/1.73m(2) . We discuss our experience with a post-FDA restriction presentation of NSF and subsequent patient death in which the prolonged lead-time of ?5.5 years led to challenges in ensuring a secure diagnosis of NSF and establishing risk exposures. Accurate contemporary records of contrast administration and clinical factors alongside clinical and pathological expertise ensured that we were able to confidently diagnose NSF, despite the length of lead time and confounding factors. PMID:24903851

  15. No Slide Title

    Cancer.gov

    FDA will accept alternative, or modified, pharmacologic and toxicological studies Short-term modified toxicity or safety studies in 2 species to achieve a clinical PD endpoint Incorporate PD endpoints in toxicity studies Possible use of single, relevant species Doses based on efficacy, MED and safe BEDs, not MTDs Not a Microdose Study!

  16. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  17. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  18. FDA Approves Panobinostat for Some Patients with Multiple Myeloma

    Cancer.gov

    The Food and Drug Administration (FDA) has granted accelerated approval of panobinostat (Farydak) for the treatment of patients with multiple myeloma whose cancer has progressed after treatment with at least two prior standard therapies. Panobinostat is a type of drug called a histone deacetylase (HDAC) inhibitor. The approval is for use of panobinostat in combination with bortezomib (Velcade) and dexamethasone.

  19. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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.

  5. 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

  6. Rapid preparation of lecture slides.

    PubMed

    Persson, A V; Frusha, J D; Chevalier, R J

    1985-02-01

    When lecture slides must be prepared at a moment's notice, these methods of rapid preparation will allow you to create good quality slides. Although rush jobs are usually associated with higher costs, using these methods will keep the price per slide to a minimum. An investment must be made for the initial equipment, but the cost per slide is much less than that of slides produced by the standard methods. Type produced by typewriters or computer printers is adequate for most slides, but better slides can be produced with KroyType or Letraset letters. The KL film is preferred for reverse slides of text or line drawings, and the RPC film for production of radiographic slides. If an X-omat developer is not available, Polaroid film is a good alternative for rapid production of slides. The KL reverse slide projects best and can be colored, but RPC film produces a good positive slide of typed material. We have also photographed from a computer terminal screen using the KL film to make positive slides, the Polaroid continuous tone film for reverse slides, and Polaroid color film for color slides of material composed on a computer terminal with multicolor and graphics capabilities. PMID:3992439

  7. CSE824 Presentation Scoring Sheet Paper Title:_____________________________________________________

    E-print Network

    Xing, Guoliang

    CSE824 Presentation Scoring Sheet Paper Title:_____________________________________________________ Presenter:______________________________________________________ Clarity Score: ______/4 1. Was the speaker. Are there too many texts on each slide? Did the presenter try to cram too much information on each slide

  8. 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 relationships of FDA advisory committee members. PMID:25199895

  9. FDA's critical path initiative: a perspective on contributions of biostatistics.

    PubMed

    O'Neill, R T

    2006-08-01

    This article describes the motivation for, description of, and the objectives and plans for the FDA's initiative that was introduced in March of 2004 by way of a report titled 'Innovation or Stagnation?--Challenge and Opportunity on the Critical Path to New Medical Products'. The FDA initiative is very much an outreach effort and a wake-up call to many constituencies to contribute and partner to improve the product development process and thereby to contribute to the success rate of new products that will benefit the public. We discuss in general terms where some of the opportunities and challenges exist for the discipline of biostatistics to make contributions to this effort over the next few years. In particular, guidance development in five areas is considered as is the need to devote new energy and efforts to quantitative risk assessment and safety evaluation, an area that has lagged the attention received in the efficacy evaluation area. PMID:16972706

  10. FDA/NCI Interagency Oncology Task Force (IOTF)

    Cancer.gov

    Under this effort, the two agencies share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients. Theresa Mullin, Ph.D., Assistant Commissioner, Office of Planning, Office of Policy and Planning, FDA, and Anna Barker, Ph.D., Deputy Director for Strategic Scientific Initiatives, Office of the Director, NCI, serve as the Co-Chairs for the IOTF.

  11. FDA Warns of Joint Pain Tied to Common Type 2 Diabetes Drugs

    MedlinePLUS

    ... nlm.nih.gov/medlineplus/news/fullstory_154365.html FDA Warns of Joint Pain Tied to Common Type ... are typically high. However, in a statement, the FDA said the medications "may cause joint pain that ...

  12. 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

    ...FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY...guidance entitled ``Guidance for Clinical Investigators, Industry, and...

  13. 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

    ...OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication...Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  14. 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

    ... Biosimilar Biological Product Sponsors or Applicants; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors... FDA and sponsors or applicants relating to the development and review of biosimilar...

  15. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    MedlinePLUS

    ... address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help ... to report problems to FDA Medical Product Safety Educational Resources Consumer-Friendly Reporting Form 3500B (PDF - 1. ...

  16. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ...located at http://www.fda.gov/Food/NewsEvents/default.htm. (FDA has verified the Web site addresses throughout this document...Acquisition and Grant Services (OAGS), Food and Drug Administration, 5630...

  17. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...the determination in the docket established for the application in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (c) FDA will also publish the regulatory review period determination in the...

  18. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...the determination in the docket established for the application in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (c) FDA will also publish the regulatory review period determination in the...

  19. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false FDA action on regulatory review period determinations. 60...GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period...

  20. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...2013-04-01 false FDA action on regulatory review period determinations. 60...GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period...

  1. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 false FDA action on regulatory review period determinations. 60...GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period...

  2. 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

  3. 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

  4. 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 (TCA). It examines the tumultuous history of attempts at tobacco regulation by reflecting on the history of Congressional activity to regulate tobacco sales and promotion. Furthermore, this Article suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. This approach includes increased scrutiny of manufacturer and distributor claims that trigger drug and medical device provisions, utilization of new tobacco product and modified risk tobacco product provisions, and promulgation of new FDA regulations and guidance specifically directed at e-cigarettes. PMID:24340824

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379 Section... General Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a...

  6. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false When does FDA have to issue a decision on an appeal...Detention Order? § 1.405 When does FDA have to issue a decision on an appeal...day period after the appeal is filed. If FDA either fails to provide you with an...

  7. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... What records must be made available to FDA? 111.610 Section 111.610 Food... What records must be made available to FDA? (a) You must have all records required...retention period for inspection and copying by FDA when requested. (b) If you use...

  8. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 2010-04-01 false How will FDA handle classified information in an informal...Detention Order? § 1.406 How will FDA handle classified information in an informal...security (“classified information”), FDA will not provide you with this...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section...Provisions § 1.378 What criteria does FDA use to order a detention? An officer or qualified employee of FDA may order the detention of any article...

  10. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... When must prior notice be submitted to FDA? 1.279 Section 1.279 Food and... When must prior notice be submitted to FDA? (a) Except as provided in paragraph...section, you must submit the prior notice to FDA and the prior notice submission must...

  11. 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

    ... SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA...

  12. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... The Food and Drug Administration's (FDA's) determination that a premarket notification... The Food and Drug Administration's (FDA's) determination that a premarket notification...If data or other information available to FDA, including data not submitted by...

  13. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...formerly associated with organizations subject to FDA regulation. 73a.735-201 Section 73a...formerly associated with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or appointment to the...

  14. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ...Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices...SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  15. 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

    ...Act; Availability AGENCY: Food and Drug Administration, HHS...SUMMARY: The Food and Drug Administration (FDA...Provisions of Section 107 of the FDA Food Safety Modernization Act...new fee provisions and FDA's plans for their implementation...

  16. Sliding Snow Calculator September 2009

    E-print Network

    Sliding Snow Calculator September 2009 In cold climates, sliding snow and falling ice should. Falling ice and snow can damage lower roofs. Property has been damaged and people have been injured and killed by snow and ice falling from roofs that slope to cold eaves. Snow and ice sliding off pitched

  17. 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...

  18. 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.

  19. EXPERIMENTAL STUDY OF SLIDING ISOLATED STRUCTURES WITH UPLIFT RESTRAINT

    E-print Network

    Nagarajaiah, Satish

    EXPERIMENTAL STUDY OF SLIDING ISOLATED STRUCTURES WITH UPLIFT RESTRAINT By Satish Nagarajaiah,1 isolation system with uplift restraint devices for medium-rise buildings subject to column uplift, is presented. A Teflon-disc sliding bearing with built-in uplift restraint devices is described. A quarter

  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. Statin-associated ocular disorders: the FDA and ADRAC data.

    PubMed

    Mizranita, Vinci; Pratisto, Eko Harry

    2015-10-01

    Background Statins are a class of medication indicated for atherosclerotic diseases and dyslipidemia. Since their appearance, many adverse events have been associated with their use. Ocular disorders are rare but serious adverse events of statins. Objective To report the association between statins and ocular adverse events (blurred vision, visual impairment, visual field defect, reduced visual acuity, myopia, hypermetropia, presbyopia, and astigmatism) which might be associated with muscle or liver problems by examining the frequency of ocular adverse events among the reported adverse drug reactions from the Food and Drug Administration (FDA) and Adverse Drug Reactions Advisory Committee (ADRAC) data. Setting The FDA USA and ADRAC Australia databases. Methods We conducted a retrospective study of statin-associated ocular adverse events reported to FDA between 1988 and 2013 and ADRAC between 1988 and 2011. The recoded data included: patient's age, gender, suspected drug and dosage, concomitant drug, adverse events, duration of therapy, dechallenge and rechallenge therapy. The differences in the adverse events profiles between each of the statins and atorvastatin were performed using Chi square and multivariate (logistic regression) statistical tests. Main outcome measure Percentages of subjects correlated with each Ocular adverse events. Results Among 131,755 cases of patients taking statins in the FDA, there were 2325 cases reported ocular adverse events after using statins (1.8 %). The Chi square statistic showed that the proportions of ocular adverse events varied significantly (p < 0.0001) across the different statin drugs. The most highly reported ocular adverse events associated with statins were blurred vision (48.4 %) and visual impairment (25.7 %). Results from logistic regression indicated that the ocular problems formed a greater proportion of the adverse events for subjects taking atorvastatin (2.1 %). Of the 1.8 %, ocular adverse events mostly occurred alone (60.9 %), followed by 30.3 % where muscle adverse events also were involved. The ADRAC data held 136 cases of statins associated ocular adverse events (47 patients reported blurred vision and 64 reported vision impairment). Conclusion All statins were associated with ocular side effects, with atorvastatin showed a higher incidence of ocular side effects in conjunction with muscle and liver problems. PMID:25939673

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

    PubMed

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

    2015-12-01

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

  3. 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.

  4. 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 (? = ?.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; ? = .19, p < .05), believed constituents are added to tobacco (? = .14, p < .05), or were older (? = .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

  5. 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

  6. Getting clever with the sliding ladder

    NASA Astrophysics Data System (ADS)

    De, Subhranil

    2014-07-01

    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. Clever arguments that circumvent fully fledged mathematical analyses are presented to establish two more interesting properties: no matter how large the kinetic friction coefficient between the ladder and the wall, (a) the ladder must be speeding up at all times while sliding down, and (b) the ladder must break off the wall at some point during its slide. This work serves as an example of an intuitive rather than a mathematically detailed approach that often provides a shorter route to understanding the properties of a physical system, making it pedagogically valuable. It is also shown how the arguments presented can be easily extended to a non-uniform ladder as well.

  7. Presentation Universiteit,

    E-print Network

    Kielmann, Thilo

    Giving a Talk, Thilo Kielmann, c 2002 4 Talk vs. Article Talk Article targeted to the audience take home Good slides are in rather than in Giving a Talk, Thilo Kielmann, c 2002 11 Text Slides #15; Text gives; Slides should not be crowded (5{7 lines of text). Giving a Talk, Thilo Kielmann, c 2002 12 Figure Slides

  8. FDA, companies test RFID tracking to prevent drug counterfeiting.

    PubMed

    James, John S

    2005-12-01

    The U.S. has an apparently growing problem with fake, counterfeit drugs entering the mainstream drug supply, and being fraudulently sold at full price in regular pharmacies and hospitals; some have no active ingredient, or too little, or substitute a cheap drug for an expensive one. The FDA has asked drug manufacturers to develop technology to track all shipments electronically as they move through the distribution chain; currently, RFID (radio frequency identification) is the preferred method for doing so. This article explains what is happening, and why we do not believe that this use of RFID is a privacy threat--though other privacy issues are among the most important questions we face today. PMID:16541509

  9. Large Eddy Simulation of FDA’s Idealized Medical Device

    PubMed Central

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

    2013-01-01

    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

  10. 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 fish with high levels of EPA and DHA. PMID:25072735

  11. WEBSLIDE: A "Virtual" Slide Projector Based on World Wide Web.

    ERIC Educational Resources Information Center

    Barra, Maria; Ferrandino, Salvatore; Scarano, Vittorio

    1999-01-01

    Presents the key design concepts of a software project whose objective is to provide a simple, cheap, and efficient solution for showing slides during lessons in computer labs. Contains 26 references. (DDR)

  12. Sliding Luttinger Liquids

    NASA Astrophysics Data System (ADS)

    Kane, Charles

    2002-03-01

    The classification of non Fermi liquid phases in two dimensions remains a difficult problem. In this talk we consider an anisotropic system consisting of an array of weakly coupled one dimensional wires, which may be studied using the powerful technique of 1D bosonization. This anisotropic limit may be of relevance to the stripe phases of high temperature superconductors as well as stripes in the quantum Hall effect. For a range of forward scattering interactions the coupling between the wires is shown to be irrelevant, leading to a novel ``smectic metal", or ``sliding Luttinger liquid" (SLL) phase, which is the quantum analog of sliding phases of coupled classical XY models. The anisotropic transport properties of this phase exhibit power law singularities characteristic of the 1D Luttinger liquid. We go on to show that even when the SLL phase is unstable, the SLL fixed point provides a useful starting point for describing other strongly correlated states in 2D. In particular, we show that in a perpendicular magnetic field our approach provides an elegant new formulation of the fractional quantum Hall effect. This theory describes the gap structure, edge states and quasiparticle excitations for the entire hierarchy of the quantum Hall effect, as well novel crystals of Laughlin quasiparticles.

  13. 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.

  14. Comparative evaluation of the new FDA approved THxID™-BRAF test with high resolution melting and sanger sequencing

    PubMed Central

    2014-01-01

    Background Since patients diagnosed with BRAF V600E and V600K mutated advanced melanoma show response to treatment with MAP kinase inhibitors, several sensitive methods have been developed to determine the V600 allele status of melanoma patients. Vemurafenib (Zelboraf) and dabrafenib (Tafinlar) are specific BRAF V600 inhibitors recently approved by the US FDA as single agent treatments for unresectable or metastatic melanoma in patients with the BRAF V600 mutation. Methods We assessed the new CE THxID™-BRAF diagnostic test, which is also FDA-approved as a companion diagnostic test in the US under a specific reference and compared the results of this assay with both High Resolution Melting (HRM) and Sanger sequencing in 113 melanoma FFPE samples. Results Invalid results were observed in 0/113 specimen with HRM, 5/113 (4.4%) with Sanger sequencing, and 1/113 (0.9%) with the THxID™-BRAF test. Positive percentage agreement (PPA) was 93.5% (95% CI 82.5 - 97.8) for V600E and V600K mutations combined for the THxID™-BRAF test and HRM, and negative percentage agreement (NPA) was 100.0% (95% CI 94.5 - 100.0). For the THxID™-BRAF test and Sanger, PPA was 100.0% (95% CI 92.1 - 100.0) and NPA 100.0% (95% CI 94.2 - 100.0). One V600E sample identified by THxID™-BRAF test was detected as wild-type by HRM and uninterpretable by Sanger. All V600K (n?=?3) were detected using the 3 different approaches. Finally, percent agreement values were not significantly different when using punches (n?=?77) vs. slides (n?=?36) or depending on samples characteristics such as pigmentation, necrosis, and tumor content. Conclusions This study demonstrated the high agreement between the FDA approved THxID™-BRAF assay, HRM, and Sanger sequencing. It has also highlighted the potential of THxID™-BRAF to be applied to a broader range of sample types than claimed in the current “instructions for use”, an extension that would require the ad hoc validation and approval. PMID:25037456

  15. 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 begun to keep tabs on social media promotions of prescription drugs. PMID:26673465

  16. 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.

  17. 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

    ... Product Involves the Application of Nanotechnology; Availability AGENCY: Food and Drug Administration, HHS... Nanotechnology''. This guidance is intended to provide industry with FDA's current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology. The...

  18. Development of a Course of Study in FDA Drug Regulatory Procedures

    ERIC Educational Resources Information Center

    Jacobs, Robin Wills; King, James C.

    1977-01-01

    It is evident that more colleges of pharmacy should establish some major course of study in the area of governmental drug regulatory procedures. This study is aimed at expanding cooperative educational programs through an FDA residency for pharmacy students and preparing a didactic course in FDA procedures. (LBH)

  19. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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...B Appendix B to Part 101—Graphic Enhancements Used by the FDA ER01JA93.364 ER11JY03.006 [58 FR 17332, Apr....

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false Examples of Graphic Enhancements Used by FDA A Appendix A to Part 201 Food and Drugs FOOD AND DRUG...Appendix A to Part 201—Examples of Graphic Enhancements Used by FDA I. Section 201.66 Standard Labeling Format A....

  1. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 2014-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2...Requirements for Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  2. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...2013-04-01 2013-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2...Requirements for Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  3. 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…

  4. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... proceed to market the device. (b) FDA will determine that a device is substantially equivalent to a... (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification....

  5. Biophysical Letter Real-Time Imaging of Electrical Signals with an Infrared FDA-Approved Dye

    E-print Network

    Bezanilla, Francisco

    Biophysical Letter Real-Time Imaging of Electrical Signals with an Infrared FDA-Approved Dye Jeremy that indocyanine green (ICG), an infrared fluorescent dye with FDA approval as an intravenously administered transdermally with high spatial resolution. As an infrared voltage-sensitive dye with a low toxicity profile

  6. 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.......

  7. 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...

  8. 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.

  9. 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.

  10. Vorapaxar and optimal aspirin dose: The FDA outlook.

    PubMed

    Serebruany, Victor L; Fortmann, Seth D; Kim, Moo Hyun

    2016-01-15

    Vorapaxar, a novel thrombin PAR-1 inhibitor, approved for post-myocardial infarction, and peripheral artery disease indications has been tested in 2 major clinical trials. In the successful TRA2P, antecedent aspirin (ASA) has been used in 94% of patients, and in failed TRACER in over 96% of patients. However, both trial publications were silent on the impact of ASA dose on clinical outcomes after voraparax. We determined which ASA dose range should be used in combination with voraparax based on the TRA2P and TRACER secondary FDA review. The data suggest that for both voraparax trials, younger patients, males, and diabetics received higher ASA doses. The interactions between voraparax efficacy and ASA dose ?300mg was marginally significant by Cox regressions for TRA2P (CI=1.00-1.61; p=0.048) and strongly trended in TRACER (CI=0.98-1.47; p=0.073). Bleeding rates were overall slightly higher with voraparax than with placebo, and were the highest in patients receiving ASA dosages ?300mg. However, there were no interactions between ASA dose and GUSTO moderate/severe bleeding. In conclusion, the efficacy of voraparax in TRA2P and TRACER, was slightly worse while bleeding was substantially worse with the higher over 300mg/day of ASA dosages. Voraparax label should recommend ASA daily use in 75 to 100mg range for concomitant use. PMID:26609688

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

    PubMed

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used. PMID:17055042

  12. 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.

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

    PubMed

    Zhang, Jinhui; Lin, Yujuan; Feng, Gang

    2015-12-01

    This paper addresses the sliding mode control problem for a class of Takagi-Sugeno fuzzy systems with matched uncertainties. Different from the conventional memoryless sliding surface, a memory-based sliding surface is proposed which consists of not only the current state but also the delayed state. Both robust and adaptive fuzzy sliding mode controllers are designed based on the proposed memory-based sliding surface. It is shown that the sliding surface can be reached and the closed-loop control system is asymptotically stable. Furthermore, to reduce the chattering, some continuous sliding mode controllers are also presented. Finally, the ball and beam system is used to illustrate the advantages and effectiveness of the proposed approaches. It can be seen that, with the proposed control approaches, not only can the stability be guaranteed, but also its transient performance can be improved significantly. PMID:25643421

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

    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.

  15. 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.

  16. HOWTO: Presentations General guidelines

    E-print Network

    Ábrahám, Erika

    HOWTO: Presentations General guidelines HOWTO: Presentations 1 / 23 #12;Title: A Descriptive Affiliation email address Occasion, Location, Date of the presentation Speaker's Name Short Title Date 2 / 23 #12;Outline 1 Type & Structure of the Presentation 2 Design of the Slides 3 P3 : Prepare, Practice

  17. Have Thoracic Endografting Outcomes Improved Since FDA Approval?

    PubMed Central

    Bhamidipati, Castigliano M; LaPar, Damien J; Mehta, Gaurav S; Kern, John A; Kron, Irving L; Upchurch, Gilbert R; Ailawadi, Gorav

    2011-01-01

    Objective Thoracic endovascular aneurysm repair (TEVAR) is gaining acceptance since Food and Drug Administration approval in 2005. We hypothesize that, compared to open repair (OPEN), mortality and complication rate after TEVAR have continued to improve. Methods All patients who underwent thoracic and/ or thoracoabdominal aneurysm repair from 2005 to 2007 in the Nationwide Inpatient Sample were examined. Patients were stratified by TEVAR or OPEN. Demographics, hospital characteristics, and outcomes were analyzed. Multivariable logistic regression models for complications and in-hospital mortality were developed. Results A weighted total of 7,644 had TEVAR, while 32,948 patients underwent OPEN. TEVAR utilization increased from 5.5% (2005) to 24.1% (2007). Mortality for all patients undergoing thoracic aneurysm repair decreased yearly (P<0.001). Mortality (TEVAR: 7.3%, OPEN: 9.8%, P<0.001) and complication rate (TEVAR: 24.3%, OPEN: 42.1%, P<0.001) were superior with TEVAR. The unadjusted annual mortality (7%) and complication rate (24%) following TEVAR did not improve each year, however, after risk adjustment mortality after TEVAR steadily decreased annually. Moreover, risk adjusted mortality for OPEN has improved since 2005. Multivariate analysis revealed age and ruptured aneurysm were highly predictive of death (P<0.001, respectively), while TEVAR lowered the adjusted odds of death by 18% (P<0.05). Conclusions Mortality in patients undergoing repair of thoracic aneurysms has decreased in the United States since FDA approval of stent grafts in 2005. This is due to wider adoption of TEVAR, and improved mortality in patients undergoing TEVAR or open repair. PMID:21439547

  18. Getting Through a Presentation Surviving a Presentation

    E-print Network

    Egenhofer, Max J.

    ahead of time #12;The Sins · Design slides that require scrolling · Design slides that require text from screen · Design colorful slide background · Good timing · Choose good position · Use slides input · Design slides with autoforward · Design full-screen slides · Animate input · Control your timing

  19. Chattering Free Sliding Mode Control in Magnetic Levitation System

    NASA Astrophysics Data System (ADS)

    Phuah, Jiunshian; Lu, Jianming; Yahagi, Takashi

    It is well known that sliding mode control (SMC) is capable of tackling systems with uncertainties. However, the discontinuous control signal causes a significant problem of chattering. In this paper, a new and simple approach to chattering free SMC methodology is proposed. The main purpose is to eliminate the chattering phenomenon. As a result, the chattering is eliminated and error performance of sliding mode control is improved. The reduction of the chattering of sliding mode control is achieved by using a distance function which measure the distance between the trajectory of state errors and the sliding surface as the corrective control term instead of discontinuous sign function. Experimental study carried out on a magnetic levitation system is presented. Experiments verified that the proposed control has the advantage of less chattering in SMC.

  20. Coating for hot sliding seals

    NASA Technical Reports Server (NTRS)

    Stock, J.

    1979-01-01

    Heat resistant paint is effective surface coating for sliding seals that must operate at elevated temperatures. Economical paint is easy to apply, offers minimal friction, and improves reliability of seals.

  1. 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.

  2. 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

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos...2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III...for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS....

  3. 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.

  4. 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

  5. Implications of the FDA statement on transvaginal placement of mesh: the aftermath.

    PubMed

    Koski, Michelle E; Rovner, Eric S

    2014-02-01

    The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18-24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP. PMID:24384996

  6. 78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ...Food and Drug Administration [Docket No. FDA-2011-D-0893] Center for Devices and...Appeals Processes; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug...SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

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

    PubMed Central

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

    2013-01-01

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

  8. NCI Director Asked by President to Also Assume Role of Interim Commissioner of FDA

    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).

  9. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ...1999D-4396)] Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Correction AGENCY...guidance entitled `` Draft Guidance for Clinical Investigators, Industry, and...

  10. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

  12. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

  13. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

  15. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ...guidelines apply to all FDA regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended...

  16. How You Can Know If FDA Regulates an Over-The-Counter Test

    MedlinePLUS

    ... Radiological Health 10903 New Hampshire Avenue WO66-5521 Silver Spring, MD 20993 More in Home Use Tests ... Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1- ...

  17. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Records and Recordkeeping § 111.610 What records must be made available to FDA? (a) You must...

  18. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Records and Recordkeeping § 111.610 What records must be made available to FDA? (a) You must...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 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, 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...

  2. 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...

  3. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA...

  4. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA...

  5. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA...

  6. 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

    ...the hazards that could affect food manufactured, processed...standards for conducting a hazard analysis, documenting hazards, implementing...guidance with respect to hazard analysis and preventive controls. Given...registered facilities and regulated foods, FDA will use the...

  7. 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

    ...information by the agency while maintaining confidentiality of trade secrets and individually identifiable patient information. FDA is...in its possession, while supporting the redaction of trade secrets and individually identifiable patient information from...

  8. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA...

  9. 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

    ...clinical, including any development outside the United...requested and the product development stage. The purpose of the...applicant for a biosimilar biological product who requests...FDA regarding the development and review of a...

  10. Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics.

    PubMed

    Fang, H; Su, Z; Wang, Y; Miller, A; Liu, Z; Howard, P C; Tong, W; Lin, S M

    2014-05-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a database for postmarketing drug safety monitoring and influences changes in FDA safety guidance documents such as drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standards and thus has become an important resource for regulatory science. Although the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics. PMID:24448476

  11. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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 SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA define the terms used in this part? Some of the...

  12. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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 SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.3 How does FDA define the terms used in this part? Some of the...

  13. Hearing on RU486 is held as test case fails to alter FDA's "import ban".

    PubMed

    1992-07-29

    AIDS and cancer researchers have joined with pro-choice advocates in demanding that the FDA restriction on RU-486 be lifted. In addition to offering an alternative to surgical abortion, the drug shows promise in curing some forms of inoperable brain cancer as well as controlling breast cancer. Currently the FDA has placed RU-486 on its important alert list, which means that it is illegal to bring it into the country for any reason. A pregnant American social worker named Leona Benten agreed to serve as a test case for RU-486. She tried to bring some into the country from England, but it was confiscated by US Customs Officials. She then sued the FDA claiming that their regulation of RU-486 was illegal. The US District Court in Brooklyn ruled in Benten's favor, ordering the FDA to return the drug. However, the US Court of Appeals for the Second Circuit overruled this decision, forcing her to appeal to the US Supreme Court. IN a 7-2 vote on July 17, the US Supreme Court denied Benten's petition for the return of the drug. The opinion was unsigned and the Court declined to rule of the constitutionality of the FDA policy. Rep. Ron Wyden introduced H.R 875 which would lift the ban. The manufacturer, Roussel-Uclaf, point to the FDA ban as the primary reason for not seeking approval. The situation serves to illustrate the political effect of the abortion debate in the US. PMID:12344814

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

    PubMed

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

    2014-03-01

    This paper presents a new optimal sliding mode controller using the scalar sign function method. A smooth, continuous-time scalar sign function is used to replace the discontinuous switching function in the design of a sliding mode controller. The proposed sliding mode controller is designed using an optimal Linear Quadratic Regulator (LQR) approach. The sliding surface of the system is designed using stable eigenvectors and the scalar sign function. Controller simulations are compared with another existing optimal sliding mode controller. To test the effectiveness of the proposed controller, the controller is implemented on an aluminum beam with piezoceramic sensor and actuator for vibration control. This paper includes the control design and stability analysis of the new optimal sliding mode controller, followed by simulation and experimental results. The simulation and experimental results show that the proposed approach is very effective. PMID:24119760

  15. 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.

  16. 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.

  17. 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

  18. Output Feedback Integral Sliding Mode Control for Uncertain Systems with Bounded L2 Performance

    NASA Astrophysics Data System (ADS)

    Chang, Jeang-Lin; Ting, Huan-Chan

    This paper presents an output feedback sliding mode control algorithm for linear MIMO systems with mismatched parameter uncertainties along with disturbances and matched nonlinear perturbations. A scheme of the output-dependent integral sliding surface is proposed and a control law is then designed to satisfy the reaching and sliding condition. Through utilizing H? control analytical technique, once the system is in the sliding mode, the proposed algorithm can guarantee robust stabilization and sustain the nature of performing disturbance attenuation in terms of an algebraic Riccati equation. Finally, the feasibility of our proposed algorithm is illustrated using a numerical example.

  19. Analysis of Asymmetry by a Slide-Vector.

    ERIC Educational Resources Information Center

    Zielman, Berrie; Heiser, Willem J.

    1993-01-01

    An algorithm based on the majorization theory of J. de Leeuw and W. J. Heiser is presented for fitting the slide-vector model. It views the model as a constrained version of the unfolding model. A three-way variant is proposed, and two examples from market structure analysis are presented. (SLD)

  20. Protein classification with Extended-Sequence Coding by sliding window.

    PubMed

    Rodrigues, Thiago de Souza; Cardoso, Fernanda Caldas; Teixeira, Santuza Maria Ribeiro; Oliveira, Sérgio Costa; Braga, Antônio Pádua

    2011-01-01

    A large number of unclassified sequences is still found in public databases, which suggests that there is still need for new investigations in the area. In this contribution, we present a methodology based on Artificial Neural Networks for protein functional classification. A new protein coding scheme, called here Extended-Sequence Coding by Sliding Windows, is presented with the goal of overcoming some of the difficulties of the well method Sequence Coding by Sliding Window. The new protein coding scheme uses more than one sliding window length with a weight factor that is proportional to the window length, avoiding the ambiguity problem without ignoring the identity of small subsequences Accuracy for Sequence Coding by Sliding Windows ranged from 60.1 to 77.7 percent for the first bacterium protein set and from 61.9 to 76.7 percent for the second one, whereas the accuracy for the proposed Extended-Sequence Coding by Sliding Windows scheme ranged from 70.7 to 97.1 percent for the first bacterium protein set and from 61.1 to 93.3 percent for the second one. Additionally, protein sequences classified inconsistently by the Artificial Neural Networks were analyzed by CD-Search revealing that there are some disagreement in public repositories, calling the attention for the relevant issue of error propagation in annotated databases due the incorrect transferred annotations. PMID:21519118

  1. 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;…

  2. Linear Classification of Dairy Cattle. Slide Script.

    ERIC Educational Resources Information Center

    Sipiorski, James; Spike, Peter

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

  3. 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,…

  4. Using a Slide in Beef Cattle Marketing 

    E-print Network

    Machen, Richard V.; Gill, Ronald J.

    1998-08-21

    .15/cwt = $488.36 L-5063 8-98 Using a Slide in Beef Cattle Marketing Rick Machen and Ronald Gill* *Extension Livestock Specialists, The Texas A&M University System. Down Slide A down slide is exercised when the delivered weight of the cattle is less than...

  5. Appearance Normalization of Histology Slides Jared Vicorya

    E-print Network

    Appearance Normalization of Histology Slides Jared Vicorya , Heather D. Couturea , Nancy E. Thomasb and intensity normalization of digitized histology slides stained with two different agents. In comparison for histology slides, the proposed method has significant practical utility. In particular, it can be used

  6. Mannheim Type Slide Rule with Leather Sleeve

    USGS Multimedia Gallery

    Original Box & Booklets. Marketed as being made of Ivorite, this slide rule was manufactured by Keuffel & Esser Company, New York & New Jersey in the 1960s. All slide rules consist of three parts (the stock, the slide and the cursor or indicator) and have logarithmic scales that can be moved in rela...

  7. 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…

  8. Smoke Conditions from Slide Fire

    USGS Multimedia Gallery

    Smoke from the Slide fire, a major wildfire near Flagstaff, Arizona, is apparent in this hemispheric, natural-color image of sky conditions.  The image was acquired at the USGS Flagstaff Science Campus at 3:00 p.m. MST on May 21, 2014 by the High Dynamic Range All-Sky Imaging System (...

  9. 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…

  10. FDA'S food ingredient approval process: Safety assurance based on scientific assessment.

    PubMed

    Rulis, Alan M; Levitt, Joseph A

    2009-02-01

    Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers. PMID:18983884

  11. 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...

  12. 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…

  13. "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.

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

    DOEpatents

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

    2013-01-15

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

  15. Time-resolved particle image velocimetry measurements with wall shear stress and uncertainty quantification for the FDA benchmark nozzle model

    E-print Network

    Raben, Jaime S; Robinson, Ronald; Malinauskas, Richard; Vlachos, Pavlos P

    2014-01-01

    We present validation of benchmark experimental data for computational fluid dynamics (CFD) analyses of medical devices using advanced Particle Image Velocimetry (PIV) processing and post-processing techniques. This work is an extension of a previous FDA-sponsored multi-laboratory study, which used a medical device mimicking geometry referred to as the FDA benchmark nozzle model. Time-resolved PIV analysis was performed in five overlapping regions of the model for Reynolds numbers in the nozzle throat of 500, 2,000, 5,000, and 8,000. Images included a two-fold increase in spatial resolution in comparison to the previous study. Data was processed using ensemble correlation, dynamic range enhancement, and phase correlations to increase signal-to-noise ratios and measurement accuracy, and to resolve flow regions with large velocity ranges and gradients, which is typical of many blood-contacting medical devices. Parameters relevant to device safety, including shear stress at the wall and in bulk flow, were comput...

  16. Automated single-slide staining device

    NASA Technical Reports Server (NTRS)

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

    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.

  17. Wide-field lensfree imaging of tissue slides

    NASA Astrophysics Data System (ADS)

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

    2015-07-01

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

  18. Assessment of the FDA backgrounder on platinum in silicone breast implants: implications for public health policy.

    PubMed

    Maharaj, S V M

    2008-01-01

    A recent report by the U.S. Food and Drug Administration reviewed the literature on the subject of platinum in silicone gel-filled breast implants. In this study the author evaluates the FDA report for scientific accuracy and impartiality, and provides relevant discussions on financial conflicts of interest, an Institute of Medicine report, and public health policy. The study suggests that the FDA used discredited scientific practices in compiling its report. Reports by regulatory agencies should be scientifically accurate, with no partiality to industry. The current policy of one-way information flow from the FDA directly to those being informed needs to be revised. Greater importance should be placed on studies in which authors have no financial conflicts of interest. PMID:18341124

  19. 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.

  20. 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 of cross sections of levees, see companion paper of Koelewijn & Vastenburg (2013). Data acquired in the field, such as topographic and bathymetric data, is processed automatically so that it can be used in the stability analyses. Geological information, such as the presence of loosely packed sand layers, is incorporated in a stochastic fashion. The platform has already been applied in various parts of The Netherlands. Koelewijn, A.R., Vastenburg, E.W. (2013). Dike Strength Analysis on a Regional Scale. Submitted abstract for the AGU Fall meeting 2013.

  1. 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

  2. The Edison Environmental Center Permeable Pavement Site - slides

    EPA Science Inventory

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

  3. 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.

  4. Exploration of the Humboldt Slide using Anisotropy of Magnetic Susceptibility - Comparison with the Gaviota Slide

    NASA Astrophysics Data System (ADS)

    Schwehr, K.; Driscoll, N.; Tauxe, L.; Lee, H. J.

    2003-12-01

    The origin of the "so-called" Humboldt Slide has raised much controversy. Some researchers argue that it is a slide deposit, while others interpret the deposit as a depositional feature mantling an old slide scar formed by down-slope gravity flows. We adapted the standard paleomagnetic tool of Anisotropy of Magnetic Susceptibility \\(AMS\\) in order to detect minor post-depositional deformation \\(i.e., "crypto-slumps"\\) in sedimentary successions and applied it to the Humboldt Slide controversy. Crypto-slumps are slumps that are not easily observed in outcrop or core samples. Undeformed sediments show a typical oblate fabric while even slightly deformed sediments develop a triaxial fabric. Based on examining cores from the center and top of the Humboldt Slide structure, we find no evidence for deformation. The cores from the top are in an area that is clearly free from drape and thus we can be sure that we are sampling the structure seen in chirp seismics. We recently sampled a known slide for comparison to the Humboldt Slide. We used 5 gravity cores from the USGS V1-81-SC cruise which sampled the Gaviota Slide. The Gaviota Slide in on the northern slope of the Santa Barbara Basin and is just to the west of the much larger Golita Slide. The AMS measurements from the Gaviota Slide show a clearly deformed fabric that we expect from a slide. From these analyses we found that the fabric is dominantly oblate for the Humboldt Slide while the Gaviota Slide is predominantly triaxial. Based on these results, we re-emphasize our conclusion that the Humboldt Slide is not a slide. We now know that the ridges and swales of the Humboldt Slide appear to have grown as sediment waves on an old slide scar and our chirp seismics show thickening on the upslope side of these structures and continuous reflectors across regions where others have mapped normal faults.

  5. Effect of Microstructural Variation on Dry Sliding Wear Behavior of Ti-6Al-4V Alloy

    NASA Astrophysics Data System (ADS)

    Sahoo, R.; Jha, B. B.; Sahoo, T. K.; Sahoo, D.

    2014-06-01

    The present article evaluates the influence of independent control factors such as microstructural variation, normal load, sliding velocity, and test duration on dry sliding wear behavior of Ti-6Al-4V alloy at room temperature using a statistical approach. Ti-6Al-4V alloy has been heat treated in a controlled manner in order to produce different microstructural features (i.e., lamellar, bimodal, and equiaxed). Lamellar microstructure is found to be harder than bimodal microstructure followed by equiaxed microstructure in Ti-6Al-4V alloy. Dry sliding wear tests have been carried out using a multiple Tribo tester following a well planned experimental schedule based on Taguchi's L9 orthogonal array design. Dry sliding wear behavior of Ti-6Al-4V alloy consisting of various microstructural features is related to their hardness values. Results indicated that lamellar microstructure has the lowest sliding wear resistance followed by bimodal and equiaxed microstructure. With the help of signal-to-noise ratios, optimal combination of control factors to minimize the dry sliding wear in Ti-6Al-4V alloy has been determined. Normal load is the most significant control factor influencing the dry sliding wear behavior of investigated Ti-6Al-4V alloy followed by sliding velocity, test duration, and microstructural variation. Normal load has greater static influence of 27.02%, sliding velocity has an influence of 18.07%, test duration has an influence of 12.71%, and microstructural variation has an influence of 10.55% on weight loss of Ti-6Al-4V alloy due to wear having R 2 = 0.89. Two wear mechanisms have been identified: oxidative wear occurs at the lowest sliding velocity and delamination wear occurs at the highest sliding velocity. Optical microscopy, scanning electron microscopy, energy dispersive x-ray spectroscopy, and Rockwell hardness measurements have been used to characterize the microstructures in order to correlate the results obtained.

  6. An Introduction to Buddhism: Slide/Script Presentation.

    ERIC Educational Resources Information Center

    Lott, Bruce

    A basic introduction to Buddhism is provided in this unit of study for high school students. The unit can be taught in social studies, geography, humanities, or religion courses. Time required is two class periods of 45 to 50 minutes each. The unit's objective is to help students gain a greater knowledge and appreciation of Buddhism and its…

  7. Presentation Software Choosing the Best Software for your Presentation

    E-print Network

    Kunkle, Tom

    Presentation Software Choosing the Best Software for your Presentation PowerPoint Basics Make it Clear After organizing your information, be sure your visual presentation communicates your intended or flashing) unless it adds to the message of the slide. Don't use sound effects during a presentation

  8. 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.

  9. 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.

  10. 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)

  11. 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 Appendix A to Part 201 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic...

  12. Research paper Screen of FDA-approved drug library reveals compounds that protect hair cells

    E-print Network

    Rubel, Edwin

    Accepted 9 August 2012 Available online xxx a b s t r a c t Loss of mechanosensory hair cells in the innerResearch paper Screen of FDA-approved drug library reveals compounds that protect hair cells from ear accounts for many hearing loss and balance disorders. Several beneficial pharmaceutical drugs

  13. MSC-based product characterization for clinical trials: an FDA perspective.

    PubMed

    Mendicino, Michael; Bailey, Alexander M; Wonnacott, Keith; Puri, Raj K; Bauer, Steven R

    2014-02-01

    Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential challenges for clinical translation. PMID:24506881

  14. 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

    ... regulated foods, FDA will use the guidance to assist the food and feed industries in complying with the... practices for hazards and controls identified by industry for specific types of food and feed and specific...:// delivery/Courier Agency name and www.regulations.g (for paper, disk, the docket number ov. Follow the or...

  15. 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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...certain provisions of the Animal Generic Drug User Fee...technology. FDA Form 3728, Animal Generic Drug User Fee...Federal Food, Drug, and Cosmetic Act (FD&C Act...applications for generic new animal drugs, (2) annual...generic new animal drug products, and (3) annual...

  17. Identification of antimicrobial activity among FDA-approved drugs for combating Mycobacterium abscessus and Mycobacterium chelonae

    E-print Network

    Huang, Ching-Tsan

    -resistantClarithromycin minimum inhibitory concentration (MIC)non-tuberculosis mycobacterium (NTM) Anti-tuberculosis bacterium Identification of antimicrobial activity among FDA-approved drugs for combating Mycobacterium abscessus and Mycobacterium chelonae Sidarth Chopra*, Karen Matsuyama, Christopher Huston and Peter Madrid

  18. 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...

  19. A Good Year: FDA Approved Nine New Cancer Drugs in 2014

    Cancer.gov

    In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false FDA recognition of exclusive marketing rights. 516.34 Section 516.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor...

  1. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... in the Federal Register of May 24, 2011 (76 FR 30175). The document announced the availability of a...-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-12623, appearing on page 30175, in the Federal... SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA...

  2. 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...

  3. Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

    PubMed

    Deyo, Richard A

    2004-01-01

    Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval. PMID:15082674

  4. APPENDIX FOR "THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN CAPITAL"

    E-print Network

    Sprott, Julien Clinton

    trends, 58 % decline in antidepressant use among individuals newly diagnosed with depression (within 30 in antidepressant use among individuals newly diagnosed with depression (within 30 days post diagnosis.) Valluri etAPPENDIX FOR "THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN CAPITAL

  5. 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

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

    PubMed

    Xiao, Lingfei; Zhu, Yue

    2014-07-01

    For a class of systems who suffers from disturbances, an original output feedback sliding mode control method is presented based on a novel tracking error observer with disturbance estimator. The mathematical models of the systems are not required to be with high accuracy, and the disturbances can be vanishing or nonvanishing, while the bounds of disturbances are unknown. By constructing a differential sliding surface and employing reaching law approach, a sliding mode controller is obtained. On the basis of an extended disturbance estimator, a creative tracking error observer is produced. By using the observation of tracking error and the estimation of disturbance, the sliding mode controller is implementable. It is proved that the disturbance estimation error and tracking observation error are bounded, the sliding surface is reachable and the closed-loop system is robustly stable. The simulations on a servomotor positioning system and a five-degree-of-freedom active magnetic bearings system verify the effect of the proposed method. PMID:24795033

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. Addressing technical challenges associated with the FDA's proposed rules for the UVA in vitro testing procedure.

    PubMed

    Dueva-Koganov, Olga V; Rocafort, Colleen; Orofino, Steven; Osterwalder, Uli; Brito, Juan

    2009-01-01

    The proposed rules of the Food and Drug Administration (FDA) for the UVA in vitro testing procedure were applied to the evaluation of various sunscreen formulations and the following technical challenges were observed: when proposed roughened quartz substrates were used, the required coefficient-of-variation criteria were not met, and the dynamic ranges of the available transmittance analyzers were exceeded for sunscreens with high SPF values. In the proposed rules, the FDA requested comment regarding the suitability of other possible substrates. In this research, two modifications to the FDA's proposed rules were evaluated: (a) the use of an alternative substrate, Vitro Skin N-19 (IMS, Inc.) instead of roughened quartz substrate and (b) an increase in application time from 10 seconds to 30 seconds to ensure a uniform distribution of sunscreen product over the application area of the substrate. These two modifications allowed meeting the required coefficient-of-variation criteria without exceeding the dynamic ranges of the available transmittance analyzers. The modified test conditions were utilized for the evaluation of six commercial sunscreens, which fulfilled criteria of "medium" or "high" categories-based on their UVAI/UV ratios. These findings were in agreement with the statement in the proposed rules that the FDA is aware of the difficulty for current sunscreen formulations to meet the "highest" category and believes that allowing such a category will foster additional research and development in this area. To determine if it was possible to achieve a UVA rating greater than 0.95, two experimental sunscreen prototypes with bisoctrizole (USAN), bemotrizinol (USAN), avobenzone, and octocrylene were tested under the modified test conditions and attained the "highest" category. It should be noted that bisoctrizole and bemotrizinol are being evaluated by the FDA under TEA and are not permitted in the US at this time, but they are approved for use in the rest of the world. PMID:20038348

  15. IMPACT OF FDA DRUG RISK COMMUNICATIONS ON HEALTH CARE UTILIZATION AND HEALTH BEHAVIORS: A SYSTEMATIC REVIEW

    PubMed Central

    Dusetzina, Stacie B.; Higashi, Ashley S.; Dorsey, E. Ray; Conti, Rena; Huskamp, Haiden A.; Zhu, Shu; Garfield, Craig F.; Alexander, G. Caleb

    2012-01-01

    Objective To review literature on the impact of FDA drug risk communications on medication utilization, health care services use, and health outcomes. Data Sources The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Study Selection Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. Data Extraction We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Results Of the 1432 records screened, 49 studies were included. These studies covered sixteen medicines or therapeutic classes; one-third examined communications regarding antidepressants. Most used medical or pharmacy claims and few rigorously examined patient-provider communication, decision-making or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only transient and modestly increased monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, though the magnitude of substitution within therapeutic classes varied across clinical contexts. Conclusions While some FDA drug risk communications had immediate, strong impacts, many had either delayed or no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts. PMID:22266704

  16. High speed sliding of axonemal microtubules produced by outer arm dynein.

    PubMed

    Seetharam, Raviraja N; Satir, Peter

    2005-02-01

    To study dynein arm activity at high temporal resolution, axonemal sliding was measured field by field for wild type and dynein arm mutants of Tetrahymena thermophila. For wt SB255 cells, when the rate of data acquisition was 60 fps, about 5x greater than previously published observations, sliding was observed to be discontinuous with very high velocity sliding (average 196 microm/sec) for a few msec (1 or 2 fields) followed by a pause of several fields. The sliding velocities measured were an order of magnitude greater than rates previously measured by video analysis. However, when the data were analyzed at 12 fps for the same axonemes, consistent with previous observations, sliding was linear as the axonemes extended several times their original length with an average velocity of approximately 10 microm/sec. The pauses or stops occurred at approximately 200 and 300% of the initial length, suggesting that dynein arms on one axonemal doublet were initially active to the limit of extension, and then the arms on the next doublet became activated. In contrast, in a mutant where OADs are missing, sliding observed at 60 fps was continuous and slow (5 microm/sec), as opposed to the discontinuous high-velocity sliding of SB255 and of the mutant at the permissive temperature where OADs are present. High-velocity step-wise sliding was also present in axonemes from an inner arm dynein mutant (KO6). These results indicate that the high-speed discontinuous pattern of sliding is produced by the mechanochemical activity of outer arm dynein. The rate of sliding is consistent with a low duty ratio of the outer arm dynein and with the operation of each arm along a doublet once per beat. PMID:15605357

  17. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Administrative Detention of Food for Human or Animal Consumption...against a detained perishable food? If FDA initiates a seizure...the act against a perishable food subject to a detention...FDA will advise the DOJ of its plans to recommend a seizure...

  18. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Administrative Detention of Food for Human or Animal Consumption...against a detained perishable food? If FDA initiates a seizure...the act against a perishable food subject to a detention...FDA will advise the DOJ of its plans to recommend a seizure...

  19. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Administrative Detention of Food for Human or Animal Consumption...against a detained perishable food? If FDA initiates a seizure...the act against a perishable food subject to a detention...FDA will advise the DOJ of its plans to recommend a seizure...

  20. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Administrative Detention of Food for Human or Animal Consumption...against a detained perishable food? If FDA initiates a seizure...the act against a perishable food subject to a detention...FDA will advise the DOJ of its plans to recommend a seizure...

  1. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Administrative Detention of Food for Human or Animal Consumption...against a detained perishable food? If FDA initiates a seizure...the act against a perishable food subject to a detention...FDA will advise the DOJ of its plans to recommend a seizure...

  2. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    PubMed Central

    Chaloupka, Frank J; Warner, Kenneth E; Acemo?lu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  3. 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; Acemo?lu, 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

  4. 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....

  5. 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

  6. 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

    ... SERVICES Food and Drug Administration 21 CFR Part 15 FDA Actions Related to Nicotine Replacement Therapies... on FDA consideration of applicable approval mechanisms and additional indications for nicotine..., including nicotine-containing gums, patches, and lozenges, are already marketed for smoking cessation....

  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. 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, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

  9. Management of a TIFS System: Organizing Tests with Instructional Feedback on Slides.

    ERIC Educational Resources Information Center

    Brown, F. Dale; Mitchell, Thomas O.

    1980-01-01

    Presents three components of the tests with instructional feedback on slides system (TIFS), the needs of the three, background on the production of the test item reference card, and the advantage of the system for both instructor and student. (MER)

  10. Slides

    E-print Network

    2012-06-20

    Jun 20, 2012 ... In Photo-acoustic Tomography, light propagates through a domain. Ab- sorbed photons ... trasound. This is the photo-acoustic effect. ..... (red), domains of uniqueness (blue) and with controlled stability (green). Guillaume Bal.

  11. Slides

    E-print Network

    Daniel J. Kelleher

    2014-08-31

    there is a unique self adjoint operator A, with DomA, such that. E(f,g) = ??f, Ag?µ = ? ... the boundary between cells (and the inverse images under the. Fi) is finite. In this case ..... non-negative bilinear form E with suitable domain, then we use.

  12. 75 FR 15376 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... prescription drug television broadcast advertisements (72 FR 47051, August 22, 2007). FDA recognizes the... FDA's draft guidance for industry entitled ``Presenting Risk Information in Prescription Drug and... less than $1 billion in 1997 (Ref. 11), industry spending on DTC advertisements for prescription...

  13. 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 from the new multibeam data at the foot of the slide, indicating minimal sediment disaggregation. The upper part of the slide has several distinct scars and internal headwalls. In particular, a 150 m high headscarp is visible from the bathymetry at water depths of ~2 km. It is possible (but unproven) that this headscarp could record a separate event from the main Traenadjupet failure, whose headscarp is located in shallower water. Dating work is ongoing to establish a robust chronology. Both a lack of disintegration and (more speculatively) multistage failure may help to explain the lack of a major associated tsunami. Together with international collaborators, we now aim to test different landslide emplacement scenarios using simple models to assess the tsunamigenic potential . 1.Bondevik et al. The Storegga tsunami along the Norwegian coast, its age and runup. Boreas(1997). 2.Haflidason et al. The Storegga Slide: architecture, geometry and slide development. Mar.Geol.(2004). 3.Laberg et al. The Trænadjupet Slide: a large slope failure affecting the continental margin of Norway 4,000 years ago. Geo-MarineLett.(2002). 4.Haflidason et al. Holocene sedimentary processes in the Andøya Canyon system, north Norway. Mar.Geol.(2007). 5.Laberg et al. Frequency and triggering mechanisms of submarine landslides of the North Norwegian continental margin. Nor.J.Geol.(2006).

  14. 3D finite element modeling of sliding wear

    NASA Astrophysics Data System (ADS)

    Buentello Hernandez, Rodolfo G.

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

  15. 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.

  16. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  17. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  18. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  19. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  20. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  1. 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

  2. Robust sliding mode control for fractional-order chaotic economical system with parameter uncertainty and external disturbance

    NASA Astrophysics Data System (ADS)

    Zhou, Ke; Wang, Zhi-Hui; Gao, Li-Ke; Sun, Yue; Ma, Tie-Dong

    2015-03-01

    This paper presents a modified sliding mode control for fractional-order chaotic economical systems with parameter uncertainty and external disturbance. By constructing the suitable sliding mode surface with fractional-order integral, the effective sliding mode controller is designed to realize the asymptotical stability of fractional-order chaotic economical systems. Comparing with the existing results, the main results in this paper are more practical and rigorous. Simulation results show the effectiveness and feasibility of the proposed sliding mode control method. Project supported by the National Natural Science Foundation of China (Grant Nos. 51207173 and 51277192).

  3. Development and Evaluation of the Virtual Pathology Slide: A New Tool in Telepathology

    PubMed Central

    Costello, Sean SP; Johnston, Daniel J; Dervan, Peter A

    2003-01-01

    Background The Virtual Pathology Slide is an interactive microscope emulator that presents, via the Internet or CD-ROM, a complete 15.53 mm x 11.61 mm digitalized tissue section. The Virtual Pathology Slide mimics the use of a microscope in both the stepwise increase in magnification (from 16x up to 2000x) and in lateral motion in the X and Y Cartesian directions. This permits a pathologist to navigate to any area on a slide, at any magnification, similar to a conventional microscope. Objective The aim of this study was to assess the diagnostic accuracy and acceptability of the Virtual Pathology Slide. Methods Ten breast needle core biopsies were randomly selected and presented to 17 pathologists or trainee pathologists with at least 2 years experience in pathology practice. Participants were required to examine each case online and provide a diagnostic classification using online feedback forms. The recorded data permitted examination of interobserver variability and user satisfaction. Results Agreement between original glass-slide diagnosis and consensus diagnosis using the Virtual Pathology Slide was reached in 9 out of 10 slides. Percentage concordance for slides lay in the range of 35.3% to 100% with an average percentage concordance between slides of 66.5%. The average Kappa statistics for interobserver agreement was 0.75 while average percentage concordance amongst participants was 66.5%. Participants looked at an average of 22 fields of view while examining each slide. Confidence: 81.25% of the participants indicated confidence using the Virtual Pathology Slide to make a diagnostic decision, with 56.25% describing themselves as "reasonably confident," 18.75% as "confident," and 6.25% as "very confident." Ease of use: 68.75% reported the system as "easy" or "very easy" to use. Satisfaction: 87.5% of participants expressed satisfaction with image quality, with 43.75% describing the image quality as "adequate," 25% describing it as "good," and 18.75% describing the image quality as "excellent." Pathologists with a working bandwidth greater than 20 kilobits per second found the download speed of the Virtual Pathology Slide "adequate" or better. Conclusions Results from this study show that the Virtual Pathology Slide can be used to make a correct diagnostic decision, and that the system is a realistic alternative to dynamic telepathology. PMID:12857667

  4. Visual Perception Slide 2 Aditi Majumder, UCI

    E-print Network

    Majumder, Aditi

    They will be detected if they move Many animals have poor depth perception (pigeon) and color vision (cats and dogs1 PERCEIVING MOVEMENT Visual Perception Slide 2 Aditi Majumder, UCI Ways to create movement Perception More than one ways to create the sense of movement Real movement is only one of them #12;2 Slide 3

  5. 1 Graphical User Interfaces a sliding puzzle

    E-print Network

    Verschelde, Jan

    characteristics and components 2 The Tk GUI Toolkit in Python Tkinter, Tk, and Tcl hello world again using grid a sliding puzzle characteristics and components 2 The Tk GUI Toolkit in Python Tkinter, Tk, and Tcl hello a sliding puzzle characteristics and components 2 The Tk GUI Toolkit in Python Tkinter, Tk, and Tcl hello

  6. 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.

  7. 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.…

  8. FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance a Little Less Passive.

    PubMed

    Mann, Justin M

    2015-01-01

    Within the last few decades, a shift has taken place in FDA's approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing scheme. The FDA Adverse Event Reporting System (FAERS) is the primary system for collecting Adverse Events, but has been criticized for years for the low reporting rate into the system and the poor quality of the information submitted. This paper argues that physicians need to be required to submit adverse event reports to FAERS, because such a requirement (1) would produce a greater number of the high quality reports necessary to better determine causality; (2) is merely an extension of physicians' ethical obligations; and (3) aligns with the approach in the Vaccine Adverse Event Reporting System (VAERS). Furthermore, advances in electronic health records can aid in reporting efficiency. PMID:26630821

  9. Repurposing FDA-approved drugs as therapeutics to treat Rift Valley fever virus infection

    PubMed Central

    Benedict, Ashwini; Bansal, Neha; Senina, Svetlana; Hooper, Idris; Lundberg, Lindsay; de la Fuente, Cynthia; Narayanan, Aarthi; Gutting, Bradford; Kehn-Hall, Kylene

    2015-01-01

    There are currently no FDA-approved therapeutics available to treat Rift Valley fever virus (RVFV) infection. In an effort to repurpose drugs for RVFV treatment, a library of FDA-approved drugs was screened to determine their ability to inhibit RVFV. Several drugs from varying compound classes, including inhibitors of growth factor receptors, microtubule assembly/disassembly, and DNA synthesis, were found to reduce RVFV replication. The hepatocellular and renal cell carcinoma drug, sorafenib, was the most effective inhibitor, being non-toxic and demonstrating inhibition of RVFV in a cell-type and virus strain independent manner. Mechanism of action studies indicated that sorafenib targets at least two stages in the virus infectious cycle, RNA synthesis and viral egress. Computational modeling studies also support this conclusion. siRNA knockdown of Raf proteins indicated that non-classical targets of sorafenib are likely important for the replication of RVFV. PMID:26217313

  10. 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.

  11. Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

    PubMed Central

    Poon, Rita; Khanijow, Keshav; Umarjee, Sphoorti; Yu, Monica; Zhang, Lei; Parekh, Ameeta

    2013-01-01

    Abstract Background Biological sex differences may contribute to differential treatment outcomes for therapeutic products. This study tracks women's participation in late-phase clinical trials (LPCTs), where efficacy and safety of drugs and biologics are evaluated, of new molecular entity (NME) drugs and biologics approved by the U.S. Food and Drug Administration (FDA) in 2007–2009. Furthermore, presentations of sex-based analyses were assessed from the FDA reviews. Methods New drug applications (NDAs) and biologics license applications (BLAs) were accessed from the U.S. FDA database and evaluated for women's participation in LPCTs. Sex-based analyses for efficacy and safety contained in FDA reviews were surveyed. Ratios for women's LPCT participation (PROPORTION OF STUDY SUBJECTS) to their proportion in the disease population were calculated for each approved therapeutic product and grouped into therapeutic categories. Results Sex-specific (n=5) and pediatric (n=3) drug applications were excluded. Women's participation in LPCTs was 39%, 48%, and 42% in NDAs (n=50) and 49%, 62%, and 58% in BLAs (n=11) for 2007, 2008, and 2009, respectively. Sixty-four percent of NDAs and 91% of BLAs had participation to proportion ratios of ?0.80. Seventy-four percent of NDA reviews and 64% of BLA reviews included safety and efficacy sex analysis. Ninety-six percent of NDA reviews and 100% of BLA reviews included efficacy sex analysis. Conclusion Women's participation in LPCTs averaged 43% for NDAs and 57% for BLAs in 2007–2009 and varied widely by indication. As a comparison, the 2001 U.S. Government Accountability Office (GAO) reported 52% of women's participation for drug clinical trials in1998–2000 and an FDA study reported 45% for BLAs approved from 1995 to 1999. This study showed that sex-analysis of both safety and efficacy in NDA has increased to 74% since the GAO report of 72%, while those for BLAs increased to 64% from 37% reported for therapeutic biologics approved in 1995–1999. Knowledge of disease prevalence and participation in clinical trials provides an understanding of recruitment and retention patterns of patients in these trials. PMID:23768021

  12. FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?

    PubMed Central

    Peterson, MC; Riggs, MM

    2015-01-01

    In the evolving discipline of quantitative systems pharmacology (QSP), QSP model (QSPM) applications are expanding. Recently, a QSPM was used by US Food and Drug Administration (FDA) clinical pharmacologists to evaluate the appropriateness of a proposed dosing regimen for a new biologic. This application expands the use-horizon for QSPMs into the regulatory domain. Here we retrace the evolution of the model and suggest a question-based approach to directing model scope, identifying applications, and understanding overall QSPM value. PMID:26225239

  13. The safety assessment process--setting the scene: an FDA perspective.

    PubMed

    Schechtman, Leonard M

    2002-01-01

    The process by which the US Food and Drug Administration (FDA) evaluates the safety/hazard potential of the products under its purview has evolved from a constellation of scientific research achievements in toxicology and related areas and a succession of historical events, some tragic, which encouraged dramatic changes in the oversight and regulation of foods, drugs, and cosmetics. The process is science based and has, over the years, achieved significant success in protecting human health. The authority by which the FDA provides pre- and postmarketing oversight of the products it regulates is established in the Federal Food, Drug, and Cosmetic Act, which has been amended extensively to broaden FDA's authority to include different products and product classes and to include oversight of safety and efficacy, greater stringency regarding reporting requirements, and enforcement processes. The structure of the agency, which comprises six regulatory components and a principal multidisciplinary research facility, is both practical and functional, providing regulatory oversight, regulatory guidance to industry, and fundamental and applied research. FDA's participation in different national and international scientific initiatives has helped bring focus to the prioritization, standardization, validation, and globalization of testing strategies and methodologies and the practical and widespread application of these initiatives to the regulation of consumer products. The agency is a leading advocate of alternative methods that refine procedures using animals to limit pain and distress, reduce and replace animal use in research and testing as scientifically appropriate and feasible, and have the potential to yield data comparable with or better than that obtained from conventional methods. The current scientific and technological advances and the rapidity with which they emerge offer new opportunities for the scientific community, industry, and regulatory authorities to alter current toxicological practices and promote the use of validated, reliable, and relevant alternative methods. PMID:12388844

  14. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health

    SciTech Connect

    Not Available

    1983-10-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing written program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section VI provides those chapters of the Compliance Program Guidance Manual which pertain to the area of radiological health. Some of the areas of coverage include laser standards; compliance testing of x-ray equipment, ultrasonic therapy devices, mercury vapor lamps, television receivers, and microwave ovens; radiation policy; and imported electronic products.

  15. My Documents\\Presentations\\IFE\\NAS\\JCF_IFE_NAS_LANL_V4Operated by Los Alamos National Security, LLC for the U.S. Department of Energy's NNSA U N C L A S S I F I E D Slide 1

    E-print Network

    A S S I F I E D Slide 2 · Addressing NRC committee charge ­ Power generation prospects ­ Challenges, cost that the physics underpinning IFE exploitation is fundamentally sound. · US is a clear world leader in IFE. Prospects National Ignition Facility aerial Moses - 31st Annual Meeting and Symposium Fusion Power

  16. 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.

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

    NASA Astrophysics Data System (ADS)

    Schneider, Nicholas M.; Brain, D. A.; Beyer, R. A.

    2010-10-01

    Planetary science is a field that is still evolving rapidly, and it can take several years for new advances to work their way into college textbooks. Yet it is important for students to have exposure to these new advances for a number of reasons. In some cases, new work renders older textbook knowledge incorrect or incomplete. In some cases, new discoveries make it possible to emphasize older textbook knowledge in a new way. In all cases, new advances provide exciting and accessible examples of the scientific process in action. To bridge the gap between textbooks and new advances in planetary sciences, we have developed content on new discoveries for use by undergraduate instructors. Called 'Discoveries in Planetary Sciences', each new discovery is summarized in a 3-slide PowerPoint presentation. The first slide describes the discovery, the second slide discusses the underlying planetary science concepts, and the third presents the big picture implications of the discovery. A fourth slide includes links to associated press releases, images, and primary sources. Topics for the slide sets span all sub-disciplines of planetary science. This effort is generously sponsored by the Division for Planetary Sciences of the American Astronomical Society. In this presentation we will discuss our motivation for this project, our implementation approach (from choosing topics to creating the slide sets, to getting them reviewed and released), and give examples of slide sets. We will also present information in the form of web statistics on how many educators are using the slide sets, and which topics are most popular. We will also present feedback from educators who have used them in the classroom. We will report on plans to release the slidesets in Spanish. This pilot program in planetary science could be expanded to other disciplines.

  18. 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…

  19. 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

  20. The viscous lubrication of rolling and sliding rigid cylinders

    NASA Technical Reports Server (NTRS)

    Carlson, S. F.; Winer, W. O.

    1974-01-01

    The viscous lubrication of rolling and sliding cylinders is studied both independently and with the aid of much of the previous work done by other investigators. Building upon the specialized results of others, a problem formulation is obtained which encompasses the general viscous fluid as well as the linear viscous fluid. A uniform solution technique is derived which is adequate for the general problem formulation. Results obtained for three special classes of viscosity functions are presented.

  1. NCI: SBIR & STTR - Resource Center - SBIR Presentations

    Cancer.gov

    This presentation contains slides from the SBIR-IMAT solicitation pre-application webinar led by NCI SBIR Program Director Amir Rahbar and featuring Tony Dickherber, Director of the NCI Innovative Molecular Analysis Technologies program.

  2. Stability of superlubric sliding on graphite

    E-print Network

    Astrid S. de Wijn; Claudio Fusco; Annalisa Fasolino

    2011-07-07

    Recent AFM experiments have shown that the low-friction sliding of incommensurate graphite flakes on graphite can be destroyed by torque-induced rotations. Here we theoretically investigate the stability of superlubric sliding against rotations of the flake. We find that the occurrence of superlubric motion critically depends on the physical parameters and on the experimental conditions: particular scan lines, thermal fluctuations and high loading forces can destroy the stability of superlubric orbits. We find that the optimal conditions to achieve superlubric sliding are given by large flakes, low temperature, and low loads, as well as scanning velocities higher than those used in AFM experiments.

  3. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

  4. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

  5. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

  6. Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule.

    PubMed

    1998-04-27

    The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval application (PMA) supplements to allow for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this tissue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule. PMID:10179319

  7. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    E-print Network

    Acemoglu, Daron

    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 ...

  8. eHealth Technologies and the FDAeHealth Technologies and the FDA William A. HermanWilliam A. Herman

    E-print Network

    Helal, Abdelsalam

    eHealth Technologies and the FDAeHealth Technologies and the FDA William A. HermanWilliam A. Herman Institute for Alternative Futures Stephen P. Bruttig Joseph F. Coates Gilbert B. Devey U.S. Army Coates

  9. NCI-FDA Interagency Oncology Task Force Workshop Provides Guidance for Analytical Validation of Protein-based Multiplex Assays

    Cancer.gov

    An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings.

  10. seminar.sty A LATEX style for slides and notes

    E-print Network

    Rowell, Eric C.

    8 Spacing parameters 8 9 Slide frames 10 II Advanced Features 12 10 Counters 12 11 Selectively including or excluding slides 12 12 Printing your slides two-up 13 13 Notes 15 14 How notes are omitted 16 bitmaps 34 D Color 35 E Landscape printing and slide rotation 36 F The semcolor style option 37 G A4

  11. 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…

  12. Fast Algorithms for the Computation of Sliding Sequency-Ordered Complex Hadamard Transform.

    PubMed

    Wu, Jiasong; Shu, Huazhong; Wang, Lu; Senhadji, Lotfi

    2010-11-01

    Fast algorithms for computing the forward and inverse sequency-ordered complex Hadamard transforms (SCHT) in a sliding window are presented. The first algorithm consists of decomposing a length-N inverse SCHT (ISCHT) into two length-N/2 ISCHTs. The second algorithm, calculating the values of window i+N/4 from those of window i and one length-N/4 ISCHT and one length-N/4 modified ISCHT (MISCHT), is implemented by two schemes to achieve a good compromise between the computation complexity and the implementation complexity. The forward SCHT algorithm can be obtained by transposing the signal flow graph of the ISCHT. The proposed algorithms require O(N) arithmetic operations and thus are more efficient than the block-based algorithms as well as those based on the sliding FFT or the sliding DFT. The application of the sliding ISCHT in transform domain adaptive filtering (TDAF) is also discussed with supporting simulation results. PMID:21909229

  13. Fast Algorithms for the Computation of Sliding Sequency-Ordered Complex Hadamard Transform

    PubMed Central

    Wu, Jiasong; Shu, Huazhong; Wang, Lu; Senhadji, Lotfi

    2010-01-01

    Fast algorithms for computing the forward and inverse sequency-ordered complex Hadamard transforms (SCHT) in a sliding window are presented. The first algorithm consists of decomposing a length-N inverse SCHT (ISCHT) into two length-N/2 ISCHTs. The second algorithm, calculating the values of window i+N/4 from those of window i and one length-N/4 ISCHT and one length-N/4 modified ISCHT (MISCHT), is implemented by two schemes to achieve a good compromise between the computation complexity and the implementation complexity. The forward SCHT algorithm can be obtained by transposing the signal flow graph of the ISCHT. The proposed algorithms require O(N) arithmetic operations and thus are more efficient than the block-based algorithms as well as those based on the sliding FFT or the sliding DFT. The application of the sliding ISCHT in transform domain adaptive filtering (TDAF) is also discussed with supporting simulation results. PMID:21909229

  14. ABB Group April 14, 2009 | Slide 1

    E-print Network

    Basse, Nils Plesner

    John Gribbin: ,,In Search of Schrödinger`s Cat" (1984) Young`s double-slit experiment The strange behaviour of light #12;© ABB Group April 14, 2009 | Slide 5 Early influences ­ science fiction books Frank

  15. 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)

  16. Variations of the Sliding Ladder Problem

    ERIC Educational Resources Information Center

    Kapranidis, Stelios; Koo, Reginald

    2008-01-01

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

  17. A Medical Tape-Slide Library

    ERIC Educational Resources Information Center

    Graves, Valerie

    1974-01-01

    Article describes a medical lending library service using tape-slide programs which started in a very small way 17 years ago and which has grown into a large concern handling some 20,000 tapes a year. (Author)

  18. Finite-time sliding mode synchronization of chaotic systems

    NASA Astrophysics Data System (ADS)

    Ni, Jun-Kang; Liu, Chong-Xin; Liu, Kai; Liu, Ling

    2014-10-01

    A new finite-time sliding mode control approach is presented for synchronizing two different topological structure chaotic systems. With the help of the Lyapunov method, the convergence property of the proposed control strategy is discussed in a rigorous manner. Furthermore, it is mathematically proved that our control strategy has a faster convergence speed than the conventional finite-time sliding mode control scheme. In addition, the proposed control strategy can ensure the finite-time synchronization between the master and the slave chaotic systems under internal uncertainties and external disturbances. Simulation results are provided to show the speediness and robustness of the proposed scheme. It is worth noticing that the proposed control scheme is applicable for secure communications.

  19. Atomic-scale study of dry sliding friction

    NASA Astrophysics Data System (ADS)

    Buldum, A.; Ciraci, S.

    1997-01-01

    We present a theoretical study of dry sliding friction, which has a close bearing on the experiments done by using the atomic and friction force microscope. By performing atomic-scale calculations for the friction between a single atom and monoatomic infinite chain, we examined the effect of various material parameters on the stick-slip motion. We found that the perpendicular elastic deformation of the substrate that is induced by the sliding object is crucial for the energy damping in friction. In this case, the average friction force strongly depends on the perpendicular force constant of the substrate and the friction constant varies with the normal force. In particular, soft materials that continue to be elastic for a wide range of perpendicular compression may exhibit a second state. As a result, the hysteresis curve in the stick-slip motion becomes anisotropic.

  20. 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.

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

    SciTech Connect

    Geng, Yongliang; Zhu, Chunao; Zhang, Bo; Anhui Provincial Key Lab of Advanced Functional Materials and Devices, Hefei University of Technology, Hefei 230009

    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.

  2. 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…

  3. Antiwear Additive Mechanisms in Sliding Contacts

    NASA Technical Reports Server (NTRS)

    Baldwin, B. A.

    1984-01-01

    The possible mechanisms associated with wear in a sliding contact and how an oil and antiwear additive can mitigate wear or prevent catastropic seizure of the contacting parts was examined. The various load and temperature regimes are examined and the mechanisms which are predominant under these conditions are determined. The critical mechanism(s) depend on the test parameters, particularly load and temperature, although sliding speed is also a factor. Different ways to improve the efficiency of antiwear additives are suggested.

  4. 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

  5. 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.

  6. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

    PubMed Central

    Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

    2015-01-01

    Objective To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Design Cohort study. Setting FDA approved novel therapeutics between 1987 and 2014. Population Publicly available sources provided each drug’s year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA’s four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Main outcome measures Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. Results The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative. PMID:26400751

  7. Records and reports regulations for radiation emitting electronic products--FDA. Final rule.

    PubMed

    1995-09-19

    The Food and Drug Administration (FDA) is amending its regulations regarding the requirements for recordkeeping and reporting of adverse experiences and other information relating to radiation emitting electronic products. This rule reduces recordkeeping and reporting requirements for some products, requires only abbreviated reporting for other products, and clarifies certain requirements. The timing and content of certain reports will be revised to enhance the usefulness of the information. These amendments will improve protection of the public health while reducing regulatory burdens on manufacturers, dealers, and distributors of radiation emitting electronic products. PMID:10151183

  8. 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.

  9. Company Presentation Company Presentation

    E-print Network

    Anand, Mahesh

    , fracture mechanics, crack growth FMECA structural reliability, technical risk assessment, statistics #12Company Presentation #12;Company Presentation Essentials Designers and manufacturers of spacecraft 04.10.2010 I page 2 #12;Company Presentation OHB Technology AG Group Structure © MT Aerospace

  10. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    PubMed Central

    2013-01-01

    Background The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8?±?45.6, during the Bush Administration (2001–2008) it was 120.4?±?33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0?±?17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3?±?36.4), Bush (29.5?±?16.2) and Obama (41.7?±?11.1). Conclusions Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required. PMID:23339419

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

    NASA Astrophysics Data System (ADS)

    Brain, D. A.; Schneider, N. M.; Beyer, R. A.

    2010-12-01

    Planetary science is a field that evolves rapidly, motivated by spacecraft mission results. Exciting new mission results are generally communicated rather quickly to the public in the form of press releases and news stories, but it can take several years for new advances to work their way into college textbooks. Yet it is important for students to have exposure to these new advances for a number of reasons. In some cases, new work renders older textbook knowledge incorrect or incomplete. In some cases, new discoveries make it possible to emphasize older textbook knowledge in a new way. In all cases, new advances provide exciting and accessible examples of the scientific process in action. To bridge the gap between textbooks and new advances in planetary sciences we have developed content on new discoveries for use by undergraduate instructors. Called 'Discoveries in Planetary Sciences', each new discovery is summarized in a 3-slide PowerPoint presentation. The first slide describes the discovery, the second slide discusses the underlying planetary science concepts, 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/. Sixteen slide sets have been released so far covering topics spanning all sub-disciplines of planetary science. Results from the following spacecraft missions have been highlighted: MESSENGER, the Spirit and Opportunity rovers, Cassini, LCROSS, EPOXI, Chandrayan, Mars Reconnaissance Orbiter, Mars Express, and Venus Express. Additionally, new results from Earth-orbiting and ground-based observing platforms and programs such as Hubble, Keck, IRTF, the Catalina Sky Survey, HARPS, MEarth, Spitzer, and amateur astronomers have been highlighted. 4-5 new slide sets are scheduled for release before December 2010. In this presentation we will discuss our motivation for this project, our implementation approach (from choosing topics to creating the slide sets, to getting them reviewed and released), and give examples of slide sets. We will present information in the form of web statistics on how many educators are using the slide sets, and which topics are most popular. We will also present feedback from educators who have used them in the classroom, and possible new directions for our activity.

  12. Why are there no FDA-approved treatments for female sexual dysfunction?

    PubMed

    Nappi, Rossella E

    2015-01-01

    After many years of research, female sexual dysfunction (FSD) is still an unmet clinical need because no FDA-approved treatments are available for women. The bio-psychosocial model is essential to understand whether a candidate drug induces a meaningful effect over placebo on sexual symptoms with a significant impact on women's quality of life and partnership. Vasoactive agents, hormone therapy and psychoactive drugs have been investigated. Randomized placebo-controlled trials showing efficacy and safety, however, did not convince the FDA to approve either transdermal testosterone patch in postmenopausal women or the serotoninergic agent flibanserin in premenopausal women, for the treatment of hypoactive sexual desire disorder. The process of balancing efficacy and safety of a chronic treatment for a non-life threatening condition, such as FSD, is very difficult in women of any age, but there is some hope that the gender gap in sexual medicine will soon come to an end. Insightful research centered on women's needs and expectations and the availability of novel compounds, tested according to the new DSM-5 diagnostic criteria, will finally lead medical regulatory agencies to approve an effective and safe pharmacotherapy for FSD. PMID:26165387

  13. 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

  14. 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.

  15. 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

  16. Terminal sliding mode fuzzy control based on multiple sliding surfaces for nonlinear ship autopilot systems

    NASA Astrophysics Data System (ADS)

    Yuan, Lei; Wu, Han-Song

    2010-12-01

    A terminal sliding mode fuzzy control based on multiple sliding surfaces was proposed for ship course tracking steering, which takes account of rudder characteristics and parameter uncertainty. In order to solve the problem, the controller was designed by employing the universal approximation property of fuzzy logic system, the advantage of Nussbaum function, and using multiple sliding mode control algorithm based on the recursive technique. In the last step of designing, a nonsingular terminal sliding mode was utilized to drive the last state of the system to converge in a finite period of time, and high-order sliding mode control law was designed to eliminate the chattering and make the system robust. The simulation results showed that the controller designed here could track a desired course fast and accurately. It also exhibited strong robustness peculiarly to system, and had better adaptive ability than traditional PID control algorithms.

  17. 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.

  18. Seafood Contamination after the BP Gulf Oil Spill and Risks to Vulnerable Populations: A Critique of the FDA Risk Assessment

    PubMed Central

    Wong, Karen K.; Solomon, Gina M.

    2011-01-01

    Background: The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable levels [levels of concern (LOCs)] of PAH contaminants in Gulf Coast seafood. Objectives: We evaluated the degree to which the FDA’s risk criteria adequately protect vulnerable Gulf Coast populations from cancer risk associated with PAHs in seafood. Discussion: The FDA LOCs significantly underestimate risk from seafood contaminants among sensitive Gulf Coast populations by failing to a) account for the increased vulnerability of the developing fetus and child; b) use appropriate seafood consumption rates; c) include all relevant health end points; and d) incorporate health-protective estimates of exposure duration and acceptable risk. For benzo[a]pyrene and naphthalene, revised LOCs are between two and four orders of magnitude below the level set by the FDA. Comparison of measured levels of PAHs in Gulf seafood with the revised LOCs revealed that up to 53% of Gulf shrimp samples were above LOCs for pregnant women who are high-end seafood consumers. Conclusions: FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children. PMID:21990339

  19. 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.

  20. Optimal second order sliding mode control for nonlinear uncertain systems.

    PubMed

    Das, Madhulika; Mahanta, Chitralekha

    2014-07-01

    In this paper, a chattering free optimal second order sliding mode control (OSOSMC) method is proposed to stabilize nonlinear systems affected by uncertainties. The nonlinear optimal control strategy is based on the control Lyapunov function (CLF). For ensuring robustness of the optimal controller in the presence of parametric uncertainty and external disturbances, a sliding mode control scheme is realized by combining an integral and a terminal sliding surface. The resulting second order sliding mode can effectively reduce chattering in the control input. Simulation results confirm the supremacy of the proposed optimal second order sliding mode control over some existing sliding mode controllers in controlling nonlinear systems affected by uncertainty. PMID:24780159

  1. 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.

  2. 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.

  3. Cigarette Graphic Warning Labels and Smoking Prevalence in Canada: A Critical Examination and Reformulation of the FDA Regulatory Impact Analysis

    PubMed Central

    Huang, Jidong; Chaloupka, Frank J.; Fong, Geoffrey T.

    2014-01-01

    Background The estimated effect of cigarette graphic warning labels (GWLs) on smoking rates is a key input to FDA's regulatory impact analysis (RIA), required by law as part of its rulemaking process. However, evidence on the impact of GWLs on smoking prevalence is scarce. Objective The goal of this paper is to critically analyze FDA's approach to estimating the impact of GWLs on smoking rates in its RIA, and to suggest a path forward to estimating the impact of the adoption of GWLs in Canada on Canadian national adult smoking prevalence. Methods A quasi-experimental methodology was employed to examine the impact of adoption of GWLs in Canada in 2000, using the U.S. as a control. Findings We found a statistically significant reduction in smoking rates after the adoption of GWLs in Canada in comparison to the U.S. Our analyses show that implementation of GWLs in Canada reduced smoking rates by 2.87 to 4.68 percentage points, a relative reduction of 12.1 to 19.6% — 33 to 53 times larger than FDA's estimates of a 0.088 percentage point reduction. We also demonstrated that FDA's estimate of the impact was flawed because it is highly sensitive to the changes in variable selection, model specification, and the time period analyzed. Conclusions Adopting GWLs on cigarette packages reduces smoking prevalence. Applying our analysis of the Canadian GWLs, we estimate that if the U.S. had adopted GWLs in 2012, the number of adult smokers in the U.S. would have decreased by 5.3 to 8.6 million in 2013. Our analysis demonstrates that FDA's approach to estimating the impact of GWLs on smoking rates is flawed. Rectifying these problems before this approach becomes the norm is critical for FDA's effective regulation of tobacco products. PMID:24218057

  4. US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.

    PubMed

    Beitzel, Knut; Allen, Donald; Apostolakos, John; Russell, Ryan P; McCarthy, Mary Beth; Gallo, Gregory J; Cote, Mark P; Mazzocca, Augustus D

    2015-02-01

    With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market. The 510(k) application allows devices that are "substantially equivalent" to a currently marketed device to come to the market. There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered "off label." Clinicians are free to use a product off-label as long as certain responsibilities are met. Per CBER, when the intent is the practice of medicine, clinicians "have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent concern over activated PRP; however to date, the FDA has not attempted to regulate activated PRP. Clinicians using activated PRP should be mindful of these concerns and continued to stay informed. PMID:25268794

  5. Synergy Testing of FDA-Approved Drugs Identifies Potent Drug Combinations against Trypanosoma cruzi

    PubMed Central

    Ranade, Ranae M.; Don, Robert; Buckner, Frederick S.

    2014-01-01

    An estimated 8 million persons, mainly in Latin America, are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease. Existing antiparasitic drugs for Chagas disease have significant toxicities and suboptimal effectiveness, hence new therapeutic strategies need to be devised to address this neglected tropical disease. Due to the high research and development costs of bringing new chemical entities to the clinic, we and others have investigated the strategy of repurposing existing drugs for Chagas disease. Screens of FDA-approved drugs (described in this paper) have revealed a variety of chemical classes that have growth inhibitory activity against mammalian stage Trypanosoma cruzi parasites. Aside from azole antifungal drugs that have low or sub-nanomolar activity, most of the active compounds revealed in these screens have effective concentrations causing 50% inhibition (EC50's) in the low micromolar or high nanomolar range. For example, we have identified an antihistamine (clemastine, EC50 of 0.4 µM), a selective serotonin reuptake inhibitor (fluoxetine, EC50 of 4.4 µM), and an antifolate drug (pyrimethamine, EC50 of 3.8 µM) and others. When tested alone in the murine model of Trypanosoma cruzi infection, most compounds had insufficient efficacy to lower parasitemia thus we investigated using combinations of compounds for additive or synergistic activity. Twenty-four active compounds were screened in vitro in all possible combinations. Follow up isobologram studies showed at least 8 drug pairs to have synergistic activity on T. cruzi growth. The combination of the calcium channel blocker, amlodipine, plus the antifungal drug, posaconazole, was found to be more effective at lowering parasitemia in mice than either drug alone, as was the combination of clemastine and posaconazole. Using combinations of FDA-approved drugs is a promising strategy for developing new treatments for Chagas disease. PMID:25033456

  6. Synergy testing of FDA-approved drugs identifies potent drug combinations against Trypanosoma cruzi.

    PubMed

    Planer, Joseph D; Hulverson, Matthew A; Arif, Jennifer A; Ranade, Ranae M; Don, Robert; Buckner, Frederick S

    2014-07-01

    An estimated 8 million persons, mainly in Latin America, are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease. Existing antiparasitic drugs for Chagas disease have significant toxicities and suboptimal effectiveness, hence new therapeutic strategies need to be devised to address this neglected tropical disease. Due to the high research and development costs of bringing new chemical entities to the clinic, we and others have investigated the strategy of repurposing existing drugs for Chagas disease. Screens of FDA-approved drugs (described in this paper) have revealed a variety of chemical classes that have growth inhibitory activity against mammalian stage Trypanosoma cruzi parasites. Aside from azole antifungal drugs that have low or sub-nanomolar activity, most of the active compounds revealed in these screens have effective concentrations causing 50% inhibition (EC50's) in the low micromolar or high nanomolar range. For example, we have identified an antihistamine (clemastine, EC50 of 0.4 µM), a selective serotonin reuptake inhibitor (fluoxetine, EC50 of 4.4 µM), and an antifolate drug (pyrimethamine, EC50 of 3.8 µM) and others. When tested alone in the murine model of Trypanosoma cruzi infection, most compounds had insufficient efficacy to lower parasitemia thus we investigated using combinations of compounds for additive or synergistic activity. Twenty-four active compounds were screened in vitro in all possible combinations. Follow up isobologram studies showed at least 8 drug pairs to have synergistic activity on T. cruzi growth. The combination of the calcium channel blocker, amlodipine, plus the antifungal drug, posaconazole, was found to be more effective at lowering parasitemia in mice than either drug alone, as was the combination of clemastine and posaconazole. Using combinations of FDA-approved drugs is a promising strategy for developing new treatments for Chagas disease. PMID:25033456

  7. Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database

    NASA Astrophysics Data System (ADS)

    Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.

    2012-02-01

    Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

  8. Likelihood ratio test-based method for signal detection in drug classes using FDA's AERS database.

    PubMed

    Huang, Lan; Zalkikar, Jyoti; Tiwari, Ram C

    2013-01-01

    In 1968 the Food and Drug Administration (FDA) established the Adverse Event Reporting System (AERS) database containing data on adverse events (AEs) reported by patients, health care providers, and other sources through a spontaneous reporting system. FDA uses AERS for monitoring the safety of the drugs on the market after approval. Most statistical methods that are available in the literature to analyze large postmarket drug safety data for identifying drug-event combinations with disproportionately high frequencies are designed to explore signals of a single drug-AE combination, but not signals including a drug class or a group of AEs simultaneously. Those methods are also not designed to control type I error and are subject to high false discovery rates. In this paper, we first briefly review a recently developed method, known as the likelihood ratio test (LRT)-based method, which has been demonstrated to control the family-wise type I error and false discovery rates. By introducing a concept of weight matrix for the drugs (or for AEs), we then extend the LRT method for detecting signals including a class of drugs (or AEs) in addition to detecting signals of single drug (or AE). A simplified Bayesian method is also proposed and compared with LRT method. The proposed methods are applied to study the signal patterns of drug classes, namely, the gadolinium drug class for magnetic resonance imaging (MRI) and statins for hypercholesterolemia, over different time periods, using the datasets with only suspect drugs and with both suspect and concomitant drugs from the AERS database. The signals detected by the statistical methods can be confirmed by signals detected across different databases, existing medical evidence from research or regulatory resources, prospective biological studies, and also through simulation as illustrated in the application. PMID:23331230

  9. The FDA report on vorapaxar in the elderly: A convoluted dilemma.

    PubMed

    Serebruany, Victor L; Fortmann, Seth D

    2015-12-15

    There are consistent data suggesting that elderly patients benefit from less aggressive antiplatelet strategies following acute coronary syndromes. This observation is likely because advanced age is associated with greater bleeding and potentially less efficacy. Oral antiplatelet agents are often prescibed uniformly, without dose adjustments, representing a concerning reality for this patient population. Vorapaxar, a platelet thrombin PAR-1 inhibitor, has been evaluated in the TRA2P and TRACER trials, but drug efficacy and safety, with respect to age, were not discussed in detail. We sought to define the FDA-confirmed age-dependent clinical outcomes after vorapaxar. The mean and median ages in the TRA2P indicated population were about 60years, with 33.4% greater than 65years of age and 9.2% greater than 75years of age. Vorapaxar efficacy was reduced in those aged 72 or older, while bleeding rates gradually increased with age for both arms. For patients aged 75 or older, efficacy numerically favored vorapaxar, but this interaction was not statistically significant (HR=1.18; 95% CI=0.95-1.46; p=0.132). In TRACER, the point estimates by age quintile for the primary endpoint also favored vorapaxar, except for the lowest age quintile ?56 probably due to overtreatment. GUSTO moderate/severe bleeding was substantially higher with vorapaxar in both trials for the eldest age quintile (5.1% placebo vs. 7.0% vorapaxar in TRA2P; 8.4% placebo vs. 13% vorapaxar in TRACER). In conclusion, the FDA analyses reassure that vorapaxar efficacy is not reduced in the elderly. However, the bleeding risk after vorapaxar is definitely increased with advancing age. PMID:26340124

  10. 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

  11. 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 slide geometry as the simulation progresses. This is the first step in being able to simulate both the wave initiation, propagation, and inundation within the same numerical model at real-world scales for submarine slide generated tsunamis.

  12. 21 CFR 864.5850 - Automated slide spinner.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...spinner. (a) Identification. An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the...

  13. 45. March 26, 1935 View of the big slide of ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    45. March 26, 1935 View of the big slide of several hundred cubic yards of rock, spring of 1934. Another slide occurred at this same location on May 26, 1935. - Scotts Bluff Summit Road, Gering, Scotts Bluff County, NE

  14. Geometric sliding mode control: The linear and linearised theory

    E-print Network

    Hirschorn, Ron

    on the standard pendulum/cart system. Keywords. sliding mode control, linear systems, linearisation AMS Subject by Slotine and Li [1990], and a recent book concerning sliding mode control is that of Edwards, Spurgeon

  15. 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.

  16. Apparatus for correcting precision errors in slide straightness in machine tools

    DOEpatents

    Robinson, Samuel C. (Clinton, TN); Gerth, Howard L. (Knoxville, TN)

    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.

  17. Presentation Outline Presentation Outline

    E-print Network

    Serianni, Anthony S.

    in lake water can cause the explosive growth of certain organisms that can greatly impair water quality ColiscanTM plate #12;#12;#12;#12;Presentation Outline #12;#12;#12;#12;#12;#12;Lake Checkups ­ Water they tell us about lake health? . Turbidity is a measurement of water clarity. It is affected by the amount

  18. In-situ physical properties of submarine slides along the Lesser Antilles Arc derived from rock physics models

    NASA Astrophysics Data System (ADS)

    Hornbach, M. J.; Manga, M.; Adachi, T.; Breitkreuz, C. F.; Lafuerza, S.; Le Friant, A.; Morgan, S.; Ishizuka, O.; Jutzeler, M.; Slagle, A. L.; Talling, P. J.

    2012-12-01

    Submarine slides are ubiquitous along the flanks of volcanic islands and continental margins. They alter seafloor morphology, transport huge sediment volumes, and sometimes generate tsunamis. Constraining in-situ sediment physical properties, and in particular, pore fluid pressure in submarine slide debris offers insight into slope failure processes. Unfortunately, in-situ measurements of physical properties are difficult to acquire and often require specialized tools or long-term sub-seafloor hydrogeological observatories. Here, using data collected from the Lesser Antilles Volcanic Arc during IODP Expedition 340, we demonstrate that rock physics models (e.g. Dvorkin et al., 1999; Mavko et al., 2009) applied to shipboard physical properties measurements provide a valid approach for estimating in-situ P-wave, S-wave, and Poisson's ratio values for slide debris. The rock physics approach presented here is especially valuable at depths less than 80 m below the seafloor where shallow slides often exist but open-hole well logging is limited. Seismic velocities, and in particular, Poisson's ratio values obtained using the rock physics model provide insight into subsurface pore-pressure in submarine slide complexes along the Lesser Antilles Arc. Near the volcanic arc, submarine slide debris has anomalously high P-wave and S-wave velocities and low Poisson's ratios, atypical of shallowly buried marine sediments, implying over-compaction and perhaps rapid dewatering. In the slide apron away from the arc, however, slide debris generally has high porosity, low seismic velocity and anomalously high Poisson's ratio values. The inferences obtained using rock physics models are consistent with numerical models and analog laboratory experiments of debris flows that infer normal dewatering, compaction, and erosion in the run-out area of submarine slides but higher porosity and elevated fluid pressure in submarine debris flow aprons. Analysis of rock physics model results shows that Poisson's ratio typically drops sharply at the base of slides. We hypothesize that the basal boundaries of submarine slides consist of stronger, dewatered material overlain by weaker, less-compacted sediment. The analysis implies significant variability in sediment strength and permeability with depth in deep-water basins where slide debris accumulates. At IODP sites 1398 and 1399 in the Grenada Basin we observe high Poisson's ratios and anomalously high porosity in sediments older than 100ky. Our analysis suggests the permeability of some shallowly buried (<200 m below sea-level) slide debris exceeds 10^-17 m^2 at these sites; this in-part explains why elevated pressures exist in the basin. The analysis implies near-lithostatic pressure at some locations beneath the Grenada basin and perhaps in other similar settings where distal mass wasting acts as the dominant sediment source.

  19. Sliding wear, viscoelasticity, and brittleness of polymers Witold Brostowa)

    E-print Network

    North Texas, University of

    Sliding wear, viscoelasticity, and brittleness of polymers Witold Brostowa) and Haley E. Hagg; accepted 23 June 2006) We have connected viscoelastic recovery (healing) in sliding wear to free volume for polystyrene (PS). Examination of the effect of the indenter force level applied in sliding wear on the healing

  20. Connection between dynamic mechanical properties and sliding wear resistance of

    E-print Network

    North Texas, University of

    Connection between dynamic mechanical properties and sliding wear resistance of polymers W. Brostow dynamic mechanical analysis (DMA). For the same materials the sliding wear in multiple scratching along elastomer). Sliding wear was determined for several constant loads between 5 and 15 N. The penetration depth

  1. Predicting Debris-Slide Locations in Northwestern California1

    E-print Network

    Predicting Debris-Slide Locations in Northwestern California1 Mark E. Reid,2 Stephen D. Ellen,3 tested four topographic models for predicting locations of debris-slide sources: 1) slope; 2) proximity to stream; 3) SHALSTAB with "standard" parameters; and 4) debris-slide-prone landforms, which delineates

  2. | Slide 1November 5, 2015 Towards an integrated industry

    E-print Network

    Mohsenian-Rad, Hamed

    © ABB | Slide 1November 5, 2015 Towards an integrated industry The Internet of Things, Services and reliability Emerging markets US re-industrialization Industry Transport & Infrastructure #12;© ABB | Slide 3November 5, 2015 Integrated industry vision Challenges & opportunities #12;© ABB | Slide 4 Changes

  3. 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.

  4. Slide 1 Lecture 13 Amitabh Varshney

    E-print Network

    Jacobs, David

    · Temporal: Strobe lights, "Wrong" wheel rotations · Spatio-Temporal: Small objects appearing Set Slide 10 Lecture 13 Copyright Amitabh Varshney Temporal Aliasing A A A A A The wheel appears as a weighted sum of sines Image from Computer Graphics: Principles and Practice by Foley, van Dam, Feiner

  5. 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…

  6. Classes and Objects: Chapter 8, Slide 1

    E-print Network

    ++. On top of it, there are two new operators -- allocator new (and new[]) and deallocator delete (and delete[]). #12;Chapter 8, Slide 6 When new fails, it either uses new_handler or throws an exception of type bad_alloc. The operator new is involved in object creation: class X { public: X(..) { .... } // constructor .. };//end

  7. Bard Presentation Style Fred Q. Mathematician

    E-print Network

    Bloch, Ethan

    Bard Presentation Style Sample Fred Q. Mathematician 9 September 1999 #12;Single Slide, Heading The colors of the boxes in this sample presentation are the default colors, but they can be changed. Fred Q. Mathematician Bard Presentation Style Sample 9 September 1999 #12;Grouping, Bullets, Heading Fred Q

  8. 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…

  9. The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.

    PubMed

    Green, William

    2013-01-01

    The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss. PMID:24640465

  10. Deficiencies in the reporting of VD and t(1/2) in the FDA approved chemotherapy drug inserts.

    PubMed

    D'Souza, Malcolm J; Alabed, Ghada J

    2010-02-01

    Since its release in 2006, the US Food and Drug Administration (FDA) final improved format for prescription drug labeling has revamped the comprehensiveness of drug inserts, including chemotherapy drugs. The chemotherapy drug "packets", retrieved via the FDA website and other accredited drug information reporting agencies such as the Physician Drug Reference (PDR), are practically the only available unbiased summary of information. One objective is to impartially evaluate the reporting of useful pharmacokinetic parameters, in particular, Volume of Distribution (V(D)) and elimination half-life (t(1/2)), in randomly selected FDA approved chemotherapy drug inserts. The web-accessible portable document format (PDF) files for 30 randomly selected chemotherapy drugs are subjected to detailed search and the two parameters of interest are tabulated. The knowledge of the two parameters is essential in directing patient care as well as for clinical research and since the completeness of the core FDA recommendations has been found deficient, a detailed explanation of the impact of such deficiencies is provided. PMID:21643531

  11. Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices

    NASA Astrophysics Data System (ADS)

    Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua

    2008-02-01

    For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.

  12. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  13. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  14. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  15. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  16. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability AGENCY: Food and...: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.'' The... Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

  17. The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?

    PubMed

    Brandt, Lawrence J

    2008-05-01

    The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision. PMID:18477347

  18. Identification of FDA-Approved Drugs and Bioactives that Protect Hair Cells in the Zebrafish (Danio rerio) Lateral Line

    E-print Network

    Rubel, Edwin

    Identification of FDA-Approved Drugs and Bioactives that Protect Hair Cells in the Zebrafish (Danio, Seattle, WA 98109, USA Received: 29 July 2008; Accepted: 20 January 2009; Online publication: 25 February aminoglycoside-inducedhaircelldeath.Topotentiallyreduce the time required for development of drugs and drug

  19. 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 findings performed on granular materials, the present model overpredicts the lateral deformations. Therefore, a local damping proportional to the out-of-balance nodal forces is included. In spite of the simple Mohr- Coulomb failure criteria being used, the results of the present numerical model are comparative to another continuum based model.

  20. Pictorial Health Warnings on Cigarette Packs in the United States: An Experimental Evaluation of the Proposed FDA Warnings

    PubMed Central

    Reid, Jessica L.; Driezen, Pete; Boudreau, Christian

    2013-01-01

    Introduction: In 2010, the U.S. Food and Drug Administration (FDA) developed 36 proposed health warnings for cigarette packages, from which 9 were subsequently selected for implementation. The current study aimed to evaluate the perceived efficacy of the 36 proposed FDA warnings. Methods: Web-based surveys were conducted with 783 adult smokers and 510 youth in United States. Participants were randomized to view and rate two sets of 6–7 warnings, each set corresponding to one of nine health effect statements required under the Tobacco Control Act. Warnings included all 36 FDA-proposed warnings and additional warnings for comparison. Results: Youth and adults rated individual warnings similarly; in all cases where differences were found, youth perceived warnings as more effective. Comparisons on specific elements indicated that warnings were perceived as more effective if they were: full color (vs. black and white), featured real people (vs. comic book style), contained graphic images (vs. nongraphic), and included a telephone “quitline” number or personal information. Few sociodemographic differences were observed in overall perceived effectiveness: younger respondents, non-White respondents, and smokers intending to quit rated warnings higher. Conclusions: Seven of the nine health warnings selected by the FDA for implementation were among the proposed warnings rated as most effective in the current study. However, the warning(s) added for comparison were rated higher than the FDA-selected warning for five of the nine sets, suggesting some warnings could be improved for greater impact. The findings support the inclusion of a telephone “quitline” number and reinforce the importance of depicting “real” people and health effects. PMID:22505660

  1. Parametric Study of Dry Sliding Wear Behavior of Hybrid Metal Matrix Composite Produced by a Novel Process

    NASA Astrophysics Data System (ADS)

    Sharma, Pardeep; Sharma, Satpal; Khanduja, Dinesh

    2015-07-01

    In the present research work, silicon nitride (Si3N4) and graphite (Gr) ceramic powders are ball milled to obtain homogeneous mixing and consistent density of combined powder. The ball-milled powder is used as reinforcement for hybrid composite development by stir casting process in the inert atmosphere. After mixing by ball milling for 100 hours, the density of ball-milled (Si3N4 + Gr) powder is measured as 2.81 g/cm3, which is approximately equal to the density of aluminum (2.7 g/cm3). The microstructures and hardness of the manufactured hybrid composites are analyzed and compared with Si3N4- and Gr-reinforced composites. Scanning electron micrograph reveals a reasonably uniform dispersion of ball-milled (Si3N4 + Gr) reinforcement in the metal matrix composites. Hardness results reveal that hybrid composites have more hardness than Gr-reinforced and lower hardness than Si3N4-reinforced composites. The dry sliding wear behavior of aluminum matrix hybrid composites has also been investigated. Response surface methodology is used to develop wear model of hybrid composites using reinforcement percentage ( R), load ( L), sliding speed ( S), and sliding distance ( D) as the process parameters. The results of wear investigation show that increase in sliding speed ( S) and percentage reinforcement ( R) reduce the wear, while increase in sliding distance ( D) or load ( L) increases the wear of the hybrid composites. Further, the load-sliding distance and load-sliding speed interactions increase the wear, while the wear reduces due to sliding speed-sliding distance interaction in the high range. The errors between the modeled and experimental results are found within 3 to 7 pct.

  2. 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.

  3. Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.

    PubMed

    Teitelbaum, Daniel H; Guenter, Peggi; Griebel, Donna; Abrams, Steven A; Bark, Staffan; Baker, Mary; Berry, Karyn L; Bistrian, Bruce R; Brenna, J Thomas; Bonnot, Denis; Carpentier, Yvon A; Deckelbaum, Richard J; Hise, Mary; Koletzko, Berthold; Mirtallo, Jay M; Mulberg, Andrew E; O'Reilly, Randall C; Shaffer, Jonathan; von Kleist, Elke; Zaloga, Gary P; Ziegler, Thomas R

    2015-09-01

    The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean-based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. The October 2013 U.S. Food and Drug Administration (FDA)/American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Public Workshop brought together scientists, researchers, and clinical experts to present updated clinical perspectives of IVFEs, including historical development, current state of usage throughout the world, and considerations for the regulatory approval of new IVFEs in the United States. PMID:25475623

  4. Disturbance observer based sliding mode control of nonlinear mismatched uncertain systems

    NASA Astrophysics Data System (ADS)

    Ginoya, Divyesh; Shendge, P. D.; Phadke, S. B.

    2015-09-01

    This paper presents a new design of multiple-surface sliding mode control for a class of nonlinear uncertain systems with mismatched uncertainties and disturbances. In the method of multiple-surface sliding mode control, it is required to compensate for the derivatives of the virtual inputs which gives rise to the so-called problem of 'explosion of terms'. In this paper a disturbance observer based multiple-surface sliding mode control is proposed to estimate the uncertainties as well as the derivative of the virtual inputs to overcome this problem. The practical stability of the overall system is proved. The effectiveness of the proposed control strategy is illustrated via simulation of a benchmark problem and comparison with other control strategies. The proposed scheme is validated by implementing it on a serial flexible joint manipulator in the laboratory.

  5. 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.

  6. Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

    PubMed Central

    2013-01-01

    Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant. PMID:24088261

  7. FDA-Approved Selective Estrogen Receptor Modulators Inhibit Ebola Virus Infection

    PubMed Central

    Johansen, Lisa M.; Brannan, Jennifer M.; Delos, Sue E.; Shoemaker, Charles J.; Stossel, Andrea; Lear, Calli; Hoffstrom, Benjamin G.; DeWald, Lisa Evans; Schornberg, Kathryn L.; Scully, Corinne; Lehár, Joseph; Hensley, Lisa E.; White, Judith M.; Olinger, Gene G.

    2014-01-01

    Ebola viruses remain a substantial threat to both civilian and military populations as bioweapons, during sporadic outbreaks, and from the possibility of accidental importation from endemic regions by infected individuals. Currently, no approved therapeutics exist to treat or prevent infection by Ebola viruses. Therefore, we performed an in vitro screen of Food and Drug Administration (FDA)– and ex–US-approved drugs and selected molecular probes to identify drugs with antiviral activity against the type species Zaire ebolavirus (EBOV). From this screen, we identified a set of selective estrogen receptor modulators (SERMs), including clomiphene and toremifene, which act as potent inhibitors of EBOV infection. Anti-EBOV activity was confirmed for both of these SERMs in an in vivo mouse infection model. This anti-EBOV activity occurred even in the absence of detectable estrogen receptor expression, and both SERMs inhibited virus entry after internalization, suggesting that clomiphene and toremifene are not working through classical pathways associated with the estrogen receptor. Instead, the response appeared to be an off-target effect where the compounds interfere with a step late in viral entry and likely affect the triggering of fusion. These data support the screening of readily available approved drugs to identify therapeutics for the Ebola viruses and other infectious diseases. The SERM compounds described in this report are an immediately actionable class of approved drugs that can be repurposed for treatment of filovirus infections. PMID:23785035

  8. A History of the Sonocare CST-100: The First FDA-approved HIFU Device

    NASA Astrophysics Data System (ADS)

    Muratore, Robert

    2006-05-01

    The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

  9. Ceftriaxone, an FDA-approved cephalosporin antibiotic, suppresses lung cancer growth by targeting Aurora B

    PubMed Central

    Li, Xiang; Li, Haitao; Li, Shengqing; Zhu, Feng; Dong, Zigang

    2012-01-01

    Ceftriaxone, an FDA-approved third-generation cephalosporin antibiotic, has antimicrobial activity against both gram-positive and gram-negative organisms. Generally, ceftriaxone is used for a variety of infections such as community-acquired pneumonia, meningitis and gonorrhea. Its primary molecular targets are the penicillin-binding proteins. However, other activities of ceftriaxone remain unknown. Herein, we report for the first time that ceftriaxone has antitumor activity in vitro and in vivo. Kinase profiling results predicted that Aurora B might be a potential ‘off’ target of ceftriaxone. Pull-down assay data confirmed that ceftriaxone could bind with Aurora B in vitro and in A549 cells. Furthermore, ceftriaxone (500 µM) suppressed anchorage-independent cell growth by targeting Aurora B in A549, H520 and H1650 lung cancer cells. Importantly, in vivo xenograft animal model results showed that ceftriaxone effectively suppressed A549 and H520 lung tumor growth by inhibiting Aurora B. These data suggest the anticancer efficacy of ceftriaxone for the treatment of lung cancers through its inhibition of Aurora B. PMID:22962305

  10. Cloned animal products in the human food chain: FDA should protect American consumers.

    PubMed

    Butler, Jennifer E F

    2009-01-01

    Animal cloning is "complex process that lets one exactly copy the genetic, or inherited, traits of an animal." In 1997, Dolly the sheep was the first animal cloned and since then "scientists have used animal cloning to breed dairy cows, beef cattle, poultry, hogs and other species of livestock." Cloned animals are highly attractive to livestock breeders because "cloning essentially produces an identical copy of an animal with superior traits." The main purpose of cloning livestock is "more focused on efficiency and economic benefits of the producer rather than the overall effect of cloning on an animal's physical and mental welfare." The focus of this article is threefold. First, the science behind animal cloning is explained and some potential uses and risks of this technology are explored. Second, FDA's historical evolution, current regulatory authority, and limitations of that authority, is described. Lastly, a new regulatory vision recognizes the realities of 21st century global markets and the dynamic evolution of scientific discovery and technology. PMID:19999640

  11. The FDA-approved natural product dihydroergocristine reduces the production of the Alzheimer's disease amyloid-? peptides.

    PubMed

    Lei, Xiling; Yu, Jing; Niu, Qi; Liu, Jianhua; Fraering, Patrick C; Wu, Fang

    2015-01-01

    Known ?-secretase inhibitors or modulators display an undesirable pharmacokinetic profile and toxicity and have therefore not been successful in clinical trials for Alzheimer's disease (AD). So far, no compounds from natural products have been identified as direct inhibitors of ?-secretase. To search for bioactive molecules that can reduce the amount of amyloid-beta peptides (A?) and that have better pharmacokinetics and an improved safety profile, we completed a screen of ~400 natural products by using cell-based and cell-free ?-secretase activity assays. We identified dihydroergocristine (DHEC), a component of an FDA- (Food and Drug Administration)-approved drug, to be a direct inhibitor of ?-secretase. Micromolar concentrations of DHEC substantially reduced A? levels in different cell types, including a cell line derived from an AD patient. Structure-activity relationship studies implied that the key moiety for inhibiting ?-secretase is the cyclized tripeptide moiety of DHEC. A Surface Plasmon Resonance assay showed that DHEC binds directly to ?-secretase and Nicastrin, with equilibrium dissociation constants (Kd) of 25.7?nM and 9.8??M, respectively. This study offers DHEC not only as a new chemical moiety for selectively modulating the activity of ?-secretase but also a candidate for drug repositioning in Alzheimer's disease. PMID:26567970

  12. Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil.

    PubMed

    Tomljenovic, Lucija; Shaw, Christopher A

    2012-01-01

    There are not many public health issues where views are as extremely polarized as those concerning vaccines, and Merck's HPV vaccine Gardasil is a case in point. Ever since gaining the FDA's approval in 2006, Merck has been heavily criticized for their overly aggressive marketing strategies and lobbying campaigns aimed at promoting Gardasil as a mandatory vaccine. Subsequently, questions have been raised as to whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests are so obvious. Some of their advertising campaign slogans, such as "cervical cancer kills x women per year" and "your daughter could become one less life affected by cervical cancer," seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine. Although, conflicts of interests do not necessarily mean that the product itself is faulty, marketing claims should be carefully examined against factual science data. Currently Gardasil vaccination is strongly recommended by the U.S. and other health authorities while public concerns about safety and efficacy of the vaccine appear to be increasing. This discrepancy leads to some important questions that need to be resolved. The current review examines key issues of this debate in light of currently available research evidence. PMID:23061593

  13. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    PubMed Central

    Cope, Judith U.; Reaman, Gregory H.; Tonning, Joseph M.

    2015-01-01

    Background. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS) was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT. PMID:26064078

  14. Mini-implant-supported sliding jig.

    PubMed

    Pattabiraman, Vinod; Kumari, Shashikala; Sood, Raghav

    2011-01-01

    Maximum anchorage situations require appropriate anchorage control from the very beginning. This includes control of anchorage in the anteroposterior as well as vertical directions. The requirement is more critical in patients with vertical growth patterns. Loss of anchorage in such situations requires recovery mechanics that will not tax the anchor teeth in any direction while maximizing efficiency. This article describes the use of a mini-implant-supported sliding jig in one such case where unilateral anchor loss in the maxillary arch was observed. A modified sliding jig was supported with Class II elastics stretched from a mini-implant placed in the mandible. With little patient compliance, the mini-implant was used to distalize the maxillary molar to regain the lost space and achieve ideal results in the most efficient way. PMID:22299112

  15. 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

  16. Fundamentals of sliding wear in steels

    SciTech Connect

    Salesky, W.J.

    1982-11-01

    Metal composition and microstructure have a significant affect on the degree of wear. The strains produced during sliding wear exceed 5.5 true shear strain. Debris in ferrous materials particles form at a critical shear strain of 5-6. Wear particle formation in ferrous metals is associated with dislocations structures. Cracks initiate at or around dislocation cell boundaries, second phase particles, or inclusions. Crack propagation typically occurs along cell boundaries. Sliding wear debris of ferrous materials are pyrophoric, for which oxidation occurs during platelet separation from the substrate. The degree of wear particle oxidation is dependant on the availability of oxygen, the extent of deformation, the rate of heat removal, and the specific area of the wear particle. 44 figures.

  17. Sliding Friction on Wet and Dry Sand

    NASA Astrophysics Data System (ADS)

    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.

  18. Tunable harmonic vibrations of quasi one-dimensional conductors induced by sliding charge-density waves

    NASA Astrophysics Data System (ADS)

    Nikitin, M. V.; Zybtsev, S. G.; Pokrovskii, V. Ya.

    2012-07-01

    We demonstrate that samples of quasi one-dimensional compounds show torsional vibrations induced by the sliding charge-density wave (CDW). Narrowband noise at the fundamental frequency is found in the vibrations spectra. The result suggests an approach to studies of the CDW dynamics and presents CDW conductors as tunable (ultra)sonic acoustoelectronic generators—unique solids vibrating under dc voltage.

  19. 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...

  20. Slide Materials for Teaching Kanji to Non-Japanese Students. Annual Reports, Vol. 2.

    ERIC Educational Resources Information Center

    Ishida, Toshiko

    An analysis of Kanji errors made by students of Japanese at International Christian University over a period of a year, as well as answers to a questionnaire on Kanji study, indicate that the learning of Kanji relies greatly on individual work outside of class. A method is presented which uses slides to enable students to study Kanji on their own.…

  1. A Fractional Order Adaptation Law for Integer Order Sliding Mode Control of a 2DOF Robot

    E-print Network

    Efe, Mehmet Önder

    to fractional order PID controller, i.e. PI Dµ, is presented to some extent. A majority of works published so far has concentrated on fractional variants of the PID controller imple- mented for the controlA Fractional Order Adaptation Law for Integer Order Sliding Mode Control of a 2DOF Robot Mehmet

  2. 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.

  3. 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.

  4. Enhanced adaptive fuzzy sliding mode control for uncertain nonlinear systems

    NASA Astrophysics Data System (ADS)

    Roopaei, Mehdi; Zolghadri, Mansoor; Meshksar, Sina

    2009-09-01

    In this article, a novel Adaptive Fuzzy Sliding Mode Control (AFSMC) methodology is proposed based on the integration of Sliding Mode Control (SMC) and Adaptive Fuzzy Control (AFC). Making use of the SMC design framework, we propose two fuzzy systems to be used as reaching and equivalent parts of the SMC. In this way, we make use of the fuzzy logic to handle uncertainty/disturbance in the design of the equivalent part and provide a chattering free control for the design of the reaching part. To construct the equivalent control law, an adaptive fuzzy inference engine is used to approximate the unknown parts of the system. To get rid of the chattering, a fuzzy logic model is assigned for reaching control law, which acting like the saturation function technique. The main advantage of our proposed methodology is that the structure of the system is unknown and no knowledge of the bounds of parameters, uncertainties and external disturbance are required in advance. Using Lyapunov stability theory and Barbalat's lemma, the closed-loop system is proved to be stable and convergence properties of the system is assured. Simulation examples are presented to verify the effectiveness of the method. Results are compared with some other methods proposed in the past research.

  5. Career Approach to Media Development: Producing Slide and Slide-Tape Presentations. Career Education Monograph Series: Volume 1, Number 3.

    ERIC Educational Resources Information Center

    Silverman, Arnold

    The monograph is intended to demonstrate how the production of a slidetape show can become a multidisciplinary exercise that helps students become creative users of information, rather than passive receivers of information. Career education and audiovisual media instruction are both cross-disciplinary in nature and can be infused into existing…

  6. Application of Sliding Mode Methods to the Design of Reconfigurable Flight Control Systems

    NASA Technical Reports Server (NTRS)

    Wells, Scott R.

    2002-01-01

    Observer-based sliding mode control is investigated for application to aircraft reconfigurable flight control. A comprehensive overview of reconfigurable flight control is given, including, a review of the current state-of-the-art within the subdisciplines of fault detection, parameter identification, adaptive control schemes, and dynamic control allocation. Of the adaptive control methods reviewed, sliding mode control (SMC) appears very promising due its property of invariance to matched uncertainty. An overview of sliding mode control is given and its remarkable properties are demonstrated by example. Sliding mode methods, however, are difficult to implement because unmodeled parasitic dynamics cause immediate and severe instability. This presents a challenge for all practical applications with limited bandwidth actuators. One method to deal with parasitic dynamics is the use of an asymptotic observer in the feedback path. Observer-based SMC is investigated, and a method for selecting observer gains is offered. An additional method for shaping the feedback loop using a filter is also developed. It is shown that this SMC prefilter is equivalent to a form of model reference hedging. A complete design procedure is given which takes advantage of the sliding mode boundary layer to recast the SMC as a linear control law. Frequency domain loop shaping is then used to design the sliding manifold. Finally, three aircraft applications are demonstrated. An F-18/HARV is used to demonstrate a SISO pitch rate tracking controller. It is also used to demonstrate a MIMO lateral-directional roll rate tracking controller. The last application is a full linear six degree-of-freedom advanced tailless fighter model. The observer-based SMC is seen to provide excellent tracking with superior robustness to parameter changes and actuator failures.

  7. Zooming in: high resolution 3D reconstruction of differently stained histological whole slide images

    NASA Astrophysics Data System (ADS)

    Lotz, Johannes; Berger, Judith; Müller, Benedikt; Breuhahn, Kai; Grabe, Niels; Heldmann, Stefan; Homeyer, André; Lahrmann, Bernd; Laue, Hendrik; Olesch, Janine; Schwier, Michael; Sedlaczek, Oliver; Warth, Arne

    2014-03-01

    Much insight into metabolic interactions, tissue growth, and tissue organization can be gained by analyzing differently stained histological serial sections. One opportunity unavailable to classic histology is three-dimensional (3D) examination and computer aided analysis of tissue samples. In this case, registration is needed to reestablish spatial correspondence between adjacent slides that is lost during the sectioning process. Furthermore, the sectioning introduces various distortions like cuts, folding, tearing, and local deformations to the tissue, which need to be corrected in order to exploit the additional information arising from the analysis of neighboring slide images. In this paper we present a novel image registration based method for reconstructing a 3D tissue block implementing a zooming strategy around a user-defined point of interest. We efficiently align consecutive slides at increasingly fine resolution up to cell level. We use a two-step approach, where after a macroscopic, coarse alignment of the slides as preprocessing, a nonlinear, elastic registration is performed to correct local, non-uniform deformations. Being driven by the optimization of the normalized gradient field (NGF) distance measure, our method is suitable for differently stained and thus multi-modal slides. We applied our method to ultra thin serial sections (2 ?m) of a human lung tumor. In total 170 slides, stained alternately with four different stains, have been registered. Thorough visual inspection of virtual cuts through the reconstructed block perpendicular to the cutting plane shows accurate alignment of vessels and other tissue structures. This observation is confirmed by a quantitative analysis. Using nonlinear image registration, our method is able to correct locally varying deformations in tissue structures and exceeds the limitations of globally linear transformations.

  8. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    PubMed Central

    Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

    2012-01-01

    Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

  9. Challenging the FDA black box warning for high aspirin dose with ticagrelor in patients with diabetes.

    PubMed

    DiNicolantonio, James J; Serebruany, Victor L

    2013-03-01

    Ticagrelor, a novel reversible antiplatelet agent, has a Food and Drug Administration (FDA) black box warning to avoid maintenance doses of aspirin (ASA) >100 mg/daily. This restriction is based on the hypothesis that ASA doses >100 mg somehow decreased ticagrelor's benefit in the Platelet Inhibition and Patient Outcomes (PLATO) U.S. cohort. However, these data are highly postrandomized, come from a very small subgroup in PLATO (57% of patients in the U.S. site), and make no biological sense. Moreover, the ticagrelor-ASA interaction was not significant by any multivariate Cox regression analyses. The Complete Response Review for ticagrelor indicates that for U.S. PLATO patients, an ASA dose >300 mg was not a significant interaction for vascular outcomes. In the ticagrelor-ASA >300 mg cohort, all-cause and vascular mortality were not significantly increased (hazard ratio [HR] 1.27 [95% CI 0.84-1.93], P = 0.262 and 1.39 [0.87-2.2], P = 0.170), respectively. Furthermore, for major adverse cardiovascular events (MACEs), 30-day all-cause mortality, and 30-day vascular mortality, the strongest interaction is the diabetes-ASA interaction. That is, patients who had diabetes had significantly fewer MACEs through study end (0.49 [0.34-0.63], P < 0.0001), significantly less 30-day all-cause mortality (0.33 [0.20-0.56], P < 0.0001), and significantly less 30-day vascular mortality (0.35 [0.22-0.55], P < 0.0001), respectively, when given high-dose (300-325 mg) ASA, regardless of treatment (clopidogrel or ticagrelor) assignment. The black box warning for the use of maintenance ASA doses >100 mg with ticagrelor is inappropriate for patients with diabetes and not evidence based. PMID:23431005

  10. FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer.

    PubMed

    Nair, Abhilasha; Lemery, Steven J; Yang, Jun; Marathe, Anshu; Zhao, Liang; Zhao, Hong; Jiang, Xiaoping; He, Kun; Ladouceur, Gaetan; Mitra, Amit K; Zhou, Liang; Fox, Emily; Aungst, Stephanie; Helms, Whitney; Keegan, Patricia; Pazdur, Richard

    2015-12-01

    The FDA approved lenvatinib (Lenvima, Eisai Inc.) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory (RAI-refractory) differentiated thyroid cancer (DTC). In an international, multicenter, double-blinded, placebo-controlled trial (E7080-G000-303), 392 patients with locally recurrent or metastatic RAI-refractory DTC and radiographic evidence of disease progression within 12 months prior to randomization were randomly allocated (2:1) to receive either lenvatinib 24 mg orally per day (n = 261) or matching placebo (n = 131) with the option for patients on the placebo arm to receive lenvatinib following independent radiologic confirmation of disease progression. A statistically significant prolongation of progression-free survival (PFS) as determined by independent radiology review was demonstrated [HR, 0.21; 95% confidence interval (CI), 0.16-0.28; P < 0.001, stratified log-rank test], with an estimated median PFS of 18.3 months (95% CI, 15.1, NR) in the lenvatinib arm and 3.6 months (95% CI, 2.2-3.7) in the placebo arm. The most common adverse reactions, in order of decreasing frequency, observed in the lenvatinib-treated patients were hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia. Adverse reactions led to dose reductions in 68% of patients receiving lenvatinib at the 24 mg dose and 18% of patients discontinued lenvatinib for adverse reactions leading to residual uncertainty regarding the optimal dose of lenvatinib. Clin Cancer Res; 21(23); 5205-8. ©2015 AACR. PMID:26324740

  11. Challenging the FDA Black Box Warning for High Aspirin Dose With Ticagrelor in Patients With Diabetes

    PubMed Central

    DiNicolantonio, James J.; Serebruany, Victor L.

    2013-01-01

    Ticagrelor, a novel reversible antiplatelet agent, has a Food and Drug Administration (FDA) black box warning to avoid maintenance doses of aspirin (ASA) >100 mg/daily. This restriction is based on the hypothesis that ASA doses >100 mg somehow decreased ticagrelor’s benefit in the Platelet Inhibition and Patient Outcomes (PLATO) U.S. cohort. However, these data are highly postrandomized, come from a very small subgroup in PLATO (57% of patients in the U.S. site), and make no biological sense. Moreover, the ticagrelor-ASA interaction was not significant by any multivariate Cox regression analyses. The Complete Response Review for ticagrelor indicates that for U.S. PLATO patients, an ASA dose >300 mg was not a significant interaction for vascular outcomes. In the ticagrelor-ASA >300 mg cohort, all-cause and vascular mortality were not significantly increased (hazard ratio [HR] 1.27 [95% CI 0.84–1.93], P = 0.262 and 1.39 [0.87–2.2], P = 0.170), respectively. Furthermore, for major adverse cardiovascular events (MACEs), 30-day all-cause mortality, and 30-day vascular mortality, the strongest interaction is the diabetes-ASA interaction. That is, patients who had diabetes had significantly fewer MACEs through study end (0.49 [0.34–0.63], P < 0.0001), significantly less 30-day all-cause mortality (0.33 [0.20–0.56], P < 0.0001), and significantly less 30-day vascular mortality (0.35 [0.22–0.55], P < 0.0001), respectively, when given high-dose (300–325 mg) ASA, regardless of treatment (clopidogrel or ticagrelor) assignment. The black box warning for the use of maintenance ASA doses >100 mg with ticagrelor is inappropriate for patients with diabetes and not evidence based. PMID:23431005

  12. State-of-the-Art in Design Rules for Drug Delivery Platforms: Lessons from FDA-approved Nanomedicines

    PubMed Central

    Dawidczyk, Charlene M.; Kim, Chloe; Park, Jea Ho; Russell, Luisa M.; Lee, Kwan Hyi; Pomper, Martin G.; Searson, Peter C.

    2014-01-01

    The ability to efficiently deliver a drug to a tumor site is dependent on a wide range of physiologically imposed design constraints. Nanotechnology provides the possibility of creating delivery vehicles where these design constraints can be decoupled, allowing new approaches for reducing the unwanted side effects of systemic delivery, increasing targeting efficiency and efficacy. Here we review the design strategies of the two FDA-approved antibody-drug conjugates (Brentuximab vedotin and Trastuzumab emtansine) and the four FDA-approved nanoparticle-based drug delivery platforms (Doxil, DaunoXome, Marqibo, and Abraxane) in the context of the challenges associated with systemic targeted delivery of a drug to a solid tumor. The lessons learned from these nanomedicines provide important insight into the key challenges associated with the development of new platforms for systemic delivery of anti-cancer drugs. PMID:24874289

  13. The liberal state and the rogue agency: FDA’s regulation of drugs for mood disorders, 1950s–1970s?

    PubMed Central

    Shorter, Edward

    2013-01-01

    The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into “rogues,” regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional “cop” agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions. PMID:18343498

  14. FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space".

    PubMed

    Holden, Mark

    2015-01-01

    This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature. PMID:26292474

  15. Pain Management in the Elderly: An FDA Safe Use Initiative Expert Panel's View on Preventable Harm Associated with NSAID Therapy

    PubMed Central

    Taylor, Robert; Lemtouni, Salma; Weiss, Karen; Pergolizzi, Joseph V.

    2012-01-01

    Optimization of current pain management strategies is necessary in order to reduce medication risks. Promoting patient and healthcare provider education on pain and pain medications is an essential step in reducing inadequate prescribing behaviors and adverse events. In an effort to raise awareness on medication safety, the FDA has launched the Safe Use Initiative program. The program seeks to identify areas with the greatest amount of preventable harm and help promote new methods and practices to reduce medication risks. Since the establishment of the program, FDA's Safe Use initiative staff convened a panel of key opinion leaders throughout the medical community to address pain management in older adults (?65 years of age). The aim of the expert panel was to focus on areas where significant risk occurs and where potential interventions will be feasible, implementable, and lead to substantial impact. The panel suggested one focus could be the use of NSAIDs for pain management in the elderly. PMID:22400024

  16. FDA (food and drug administration) compliance program guidance manual (fy 84). Section 6. Radiological health. Updates. Irregular repts

    SciTech Connect

    Not Available

    1984-01-01

    The standing order allows one to obtain updates to Section VI of the Compliance Program Guidance Manual which provides plans and instructions to Field operatons which are surveillance and/or compliance oriented and provide needed direction from Headquarters Offices and Bureaus in accomplishing FDA's regulatory obligations for those products monitored for radiation. This section also includes the concept to the Manual and miscellaneous material relating to compliance functions.

  17. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

    PubMed

    de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

    2015-08-15

    On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (? 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. PMID:26275952

  18. Recognizing drug targets using evolutionary information: implications for repurposing FDA-approved drugs against Mycobacterium tuberculosis H37Rv.

    PubMed

    Ramakrishnan, Gayatri; Chandra, Nagasuma R; Srinivasan, Narayanaswamy

    2015-11-10

    Drug repurposing to explore target space has been gaining pace over the past decade with the upsurge in the use of systematic approaches for computational drug discovery. Such a cost and time-saving approach gains immense importance for pathogens of special interest, such as Mycobacterium tuberculosis H37Rv. We report a comprehensive approach to repurpose drugs, based on the exploration of evolutionary relationships inferred from the comparative sequence and structural analyses between targets of FDA-approved drugs and the proteins of M. tuberculosis. This approach has facilitated the identification of several polypharmacological drugs that could potentially target unexploited M. tuberculosis proteins. A total of 130 FDA-approved drugs, originally intended against other diseases, could be repurposed against 78 potential targets in M. tuberculosis. Additionally, we have also made an attempt to augment the chemical space by recognizing compounds structurally similar to FDA-approved drugs. For three of the attractive cases we have investigated the probable binding modes of the drugs in their corresponding M. tuberculosis targets by means of structural modelling. Such prospective targets and small molecules could be prioritized for experimental endeavours, and could significantly influence drug-discovery and drug-development programmes for tuberculosis. PMID:26429199

  19. Regulatory underpinnings of Global Health security: FDA's roles in preventing, detecting, and responding to global health threats.

    PubMed

    Courtney, Brooke; Bond, Katherine C; Maher, Carmen

    2014-01-01

    In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats. PMID:25254912

  20. Optimal second order sliding mode control for linear uncertain systems.

    PubMed

    Das, Madhulika; Mahanta, Chitralekha

    2014-11-01

    In this paper an optimal second order sliding mode controller (OSOSMC) is proposed to track a linear uncertain system. The optimal controller based on the linear quadratic regulator method is designed for the nominal system. An integral sliding mode controller is combined with the optimal controller to ensure robustness of the linear system which is affected by parametric uncertainties and external disturbances. To achieve finite time convergence of the sliding mode, a nonsingular terminal sliding surface is added with the integral sliding surface giving rise to a second order sliding mode controller. The main advantage of the proposed OSOSMC is that the control input is substantially reduced and it becomes chattering free. Simulation results confirm superiority of the proposed OSOSMC over some existing. PMID:25249166

  1. Characterization of surface microstructure in pure copper after severe plastic deformation by sliding

    NASA Astrophysics Data System (ADS)

    Suslov, Sergey

    This study concentrates on characterization of the surface microstructure evolution in pure copper after severe plastic deformation in the form of "wave" sliding. This deformation process is based on conventional machining with modifications in the deformation geometry which leads to a drastic change in the output. Instead of the formation of a severely deformed chip, all the deformation goes into the workpiece, forming a severely deformed region in the workpiece subsurface. The amount of strain imposed into the subsurface of the material depends on the tool rake angle and the strain rate depends on the tool speed. In the present work, this deformation method is used to study the evolution of surface microstructure with strain and strain rate, and also the development of subsurface microstructure with depth from the surface. Three rake angles of -60°, -70° and -80° and two speeds of 1 and 200 mm/s were used in "wave" sliding, and two rake angles of 0 and +50° and speed of 10 mm/s were used in machining (chip formation) to study the surface microstructure evolution. Surface and subsurface microstructures of the deformed specimens were characterized with a range of techniques including specimen preparation and imaging in the Focused Ion Beam/Scanning Electron Microscope (FIB/SEM), Transmission Electron Microscopy (TEM), Electron Backscatter Diffraction (EBSD) and Vickers microhardness. Microstructural characteristics addressed in this dissertation involve boundary spacing and misorientation of the dislocation structures formed after the deformation. Texture evolution was also addressed. It was shown that the material flow during "wave" sliding at -70° and -80° rake angle was laminar while at -60° was rotational; which resulted in subsurface homogeneous (˜1) at -70°, (˜0.5) at -80° degree and heterogeneous (˜2-3.5) at -60° effective strain distributions, respectively. It was also shown that simple shear was the main deformation mode in "wave" sliding. Deformation textures developed in machining and "wave" sliding were proven to be of simple shear type and similar those developed in torsion and ECAP. The microstructures and textures developed at the surface of a chip rake face and corresponding machined surface were similar reflecting that the same effective strain was imposed in both surfaces. It was observed that in "wave" sliding, the material strain-hardened to a larger depth with one pass at a more positive rake angle, and with each pass (1-8) at -70° rake angle. Subsurface microstructure reached steady state after four passes in -70° "wave" sliding. It was confirmed that high speed (strain rate) "wave" sliding at -80° rake angle did not result in the formation of deformation twins.

  2. Stepwise Sliding of Single Actin and Myosin Filaments

    PubMed Central

    Liu, Xiumei; Pollack, Gerald H.

    2004-01-01

    Dynamics of sliding were explored in isolated actin and myosin filaments. Sliding occurs in steps. The steps are integer multiples of 2.7 nm, which is equal to the monomeric repeat along the actin filament. When filaments were forced to slide in the reverse direction, the size paradigm was the same. This size paradigm is parallel to that seen in the kinesin-microtubule system, where step size is an integer multiple of the tubulin repeat along the microtubule. PMID:14695277

  3. The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

    PubMed

    Adamovich, Ashley; Park, Susie; Siskin, Gary P; Englander, Meridith J; Mandato, Kenneth D; Herr, Allen; Keating, Lawrence J

    2015-09-01

    The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty. PMID:26189046

  4. Second order sliding mode control for a quadrotor UAV.

    PubMed

    Zheng, En-Hui; Xiong, Jing-Jing; Luo, Ji-Liang

    2014-07-01

    A method based on second order sliding mode control (2-SMC) is proposed to design controllers for a small quadrotor UAV. For the switching sliding manifold design, the selection of the coefficients of the switching sliding manifold is in general a sophisticated issue because the coefficients are nonlinear. In this work, in order to perform the position and attitude tracking control of the quadrotor perfectly, the dynamical model of the quadrotor is divided into two subsystems, i.e., a fully actuated subsystem and an underactuated subsystem. For the former, a sliding manifold is defined by combining the position and velocity tracking errors of one state variable, i.e., the sliding manifold has two coefficients. For the latter, a sliding manifold is constructed via a linear combination of position and velocity tracking errors of two state variables, i.e., the sliding manifold has four coefficients. In order to further obtain the nonlinear coefficients of the sliding manifold, Hurwitz stability analysis is used to the solving process. In addition, the flight controllers are derived by using Lyapunov theory, which guarantees that all system state trajectories reach and stay on the sliding surfaces. Extensive simulation results are given to illustrate the effectiveness of the proposed control method. PMID:24751475

  5. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800..., cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  6. 21 CFR 864.3800 - Automated slide stainer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800..., cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

  7. Nucleosome sliding mechanisms: new twists in a looped history.

    PubMed

    Mueller-Planitz, Felix; Klinker, Henrike; Becker, Peter B

    2013-09-01

    Nucleosomes, the basic organizational units of chromatin, package and regulate eukaryotic genomes. ATP-dependent nucleosome-remodeling factors endow chromatin with structural flexibility by promoting assembly or disruption of nucleosomes and the exchange of histone variants. Furthermore, most remodeling factors induce nucleosome movements through sliding of histone octamers on DNA. We summarize recent progress toward unraveling the basic nucleosome sliding mechanism and the interplay of the remodelers' DNA translocases with accessory domains. Such domains optimize and regulate the basic sliding reaction and exploit sliding to achieve diverse structural effects, such as nucleosome positioning or eviction, or the regular spacing of nucleosomes in chromatin. PMID:24008565

  8. Mechanical anisotropy of nanostructured parylene films during sliding contact

    NASA Astrophysics Data System (ADS)

    So, Eric; Demirel, Melik C.; Wahl, Kathryn J.

    2010-02-01

    Microscale sliding friction experiments were performed on nanostructured poly-chloro-p-xylylene (PPX-Cl, a.k.a, parylene) films. Oblique-angle vapour-phase deposition resulted in nanostructured columnar films tilted 57°-63° relative to the surface. The mechanical response to sliding was studied relative to the film structural anisotropy by examining contact friction and deformation in three sliding orientations: 'with', 'against' and 'perpendicular' to the tilt axis of the columns. Friction coefficients were uniformly high (0.5-1.5) for all orientations. Neither frictional anisotropy nor depth hysteresis was observed for sliding perpendicular to the column tilt axis. However, sliding 'with' and 'against' the column tilt axis resulted in measurable friction anisotropy as well as depth hysteresis, with larger contact depths and higher friction coefficients for sliding 'with' the column tilt. In comparison, planar films did not exhibit either frictional anisotropy or depth hysteresis. The depth hysteresis during sliding parallel to the tilt axis is attributed to the lateral force contribution to the total contact loading. Contacts formed when the sliding orientation was perpendicular to the column tilt axis were nominally Hertzian, allowing estimation of elastic moduli of the films from the load-displacement data during sliding. These films may have applications in the area of tissue engineering for directional cell sheet growth, MEMS developments for directional microfluidic pumps and sensors for deformation induced detection.

  9. Bi-directional planar slide mechanism

    SciTech Connect

    Bieg, Lothar F.

    2003-11-04

    A bi-directional slide mechanism. A pair of master and slave disks engages opposite sides of the platform. Rotational drivers are connected to master disks so the disks rotate eccentrically about their respective axes of rotation. Opposing slave disks are connected to master disks on opposite sides of the platform by a circuitous mechanical linkage, or are electronically synchronized together using stepper motors, to effect coordinated motion. The synchronized eccentric motion of the pairs of master/slave disks compels smooth linear motion of the platform forwards and backwards without backlash. The apparatus can be incorporated in a MEMS device.

  10. Collective sliding states for colloidal molecular crystals

    SciTech Connect

    Reichhardt, Charles; Reichhardt, Cynthia

    2008-01-01

    We study the driving of colloidal molecular crystals over periodic substrates such as those created with optical traps. The n-merization that occurs in the colloidal molecular crystal states produces a remarkably rich variety of distinct dynamical behaviors, including polarization effects within the pinned phase and the formation of both ordered and disordered sliding phases. Using computer simulations, we map the dynamic phase diagrams as a function of substrate strength for dimers and trimers on a triangular substrate, and correlate features on the phase diagram with transport signatures.

  11. Sliding wear behavior of nanostructured WC-Co-Cr coatings

    NASA Astrophysics Data System (ADS)

    Wang, Haibin; Wang, Xuezheng; Song, Xiaoyan; Liu, Xuemei; Liu, Xingwei

    2015-11-01

    The nanostructured WC-10Co-4Cr coatings were fabricated by high velocity oxy-fuel spraying using the in situ synthesized WC-Co nanocomposite powder with size of 70-200 nm and Cr addition. Through optimization of the processing conditions, the nanostructured WC-Co-Cr coating has only a small amount of decarburized phase, a dense microstructure and an excellent combination of hardness, fracture toughness and wear resistance. A series of sliding wear tests were performed to investigate the wear behavior of the nanostructured cermet coating. The evolution of the friction coefficient, wear characteristics and their mechanisms were studied for the nanostructured WC-Co-Cr coating with the change of the load. The present study proposes a new understanding of the occurrence and the related mechanisms of the wear of the cermet coatings.

  12. Powerful Presentations with PowerPoint.

    ERIC Educational Resources Information Center

    Schenone-Stevens, M. Carla

    As educational institutions prepare to meet the challenges of the new millennium, it becomes more apparent that computer-competent students should be graduated to meet the needs of the advances in technology in the workplace. One technology that is readily available is presentation software, which allows the student to generate slides, overheads,…

  13. CARS: 2001 Presentation

    Cancer.gov

    Slide 1 Title: Information Guided Therapy Resources Laurence P. Clarke Ph.D.Branch ChiefImaging Technology DevelopmentImage Guided TherapyNCI: Biomedical Imaging Program, USA Slide 2 Image of CIP Organizational Chart NCI Division of Cancer Treatment

  14. Adaptive whole slide tissue segmentation to handle inter-slide tissue variability

    NASA Astrophysics Data System (ADS)

    Nguyen, Kien; Chen, Ting; Bredno, Joerg; Srinivas, Chukka; Chefd'hotel, Christophe; Romagnoli, Solange; Heller, Astrid; Grimm, Oliver; Gaire, Fabien

    2015-03-01

    Automatic whole slide (WS) tissue image segmentation is an important problem in digital pathology. A conventional classification-based method (referred to as CCb method) to tackle this problem is to train a classifier on a pre-built training database (pre-built DB) obtained from a set of training WS images, and use it to classify all image pixels or image patches (test samples) in the test WS image into different tissue types. This method suffers from a major challenge in WS image analysis: the strong inter-slide tissue variability (ISTV), i.e., the variability of tissue appearance from slide to slide. Due to this ISTV, the test samples are usually very different from the training data, which is the source of misclassification. To address the ISTV, we propose a novel method, called slide-adapted classification (SAC), to extend the CCb method. We assume that in the test WS image, besides regions with high variation from the pre-built DB, there are regions with lower variation from this DB. Hence, the SAC method performs a two-stage classification: first classifies all test samples in a WS image (as done in the CCb method) and compute their classification confidence scores. Next, the samples classified with high confidence scores (samples being reliably classified due to their low variation from the pre-built DB) are combined with the pre-built DB to generate an adaptive training DB to reclassify the low confidence samples. The method is motivated by the large size of the test WS image (a large number of high confidence samples are obtained), and the lower variability between the low and high confidence samples (both belonging to the same WS image) compared to the ISTV. Using the proposed SAC method to segment a large dataset of 24 WS images, we improve the accuracy over the CCb method.

  15. The decline of mountain permafrost and the occurrence of recent large debris slides in Iceland

    NASA Astrophysics Data System (ADS)

    Saemundsson, Thorsteinn; Kristinn Helgason, Jon; Petursson, Halldor

    2014-05-01

    During the last decade several, somewhat unusual, debris slides have occurred in Iceland. Most of these slides occurred in the Tröllaskagi peninsula in central north Iceland as well as in the eastern part of the island, and their starting zones are all located above 750-800 m. In most of them large blocks of frozen sediments have been observed in the slide material. The temperature rise which has been observed in Iceland during the last decades has lead to discussions about the present permafrost condition in Iceland and the possible decline of mountain permafrost. Recent studies at the Orravatnsrústir palsa site, in the highlands north of the Hofsjökull icecap give clear indications of decreasing of the permafrost during the last decade or so (Saemundsson et al. 2012). In 2011 and 2012 two large debris slides occurred in northern Iceland. In 2011 a huge slide fell from the Torfufell Mountain in the Eyjafjörður area and in 2012 another one fell from the Móafellshyrna Mountain in the Fljót area. In both these cases the slides originated at about 750-800 m a.s.l. and large chunks of frozen sediments transported down the mountain sides. The Torfufell debris slide fell on the 14th of October 2011, after exceptionally warm summer and unusually rainy fall. The slide originated along a 200 m long fissure at 800 m.a.s.l in a NW facing slope. Big blocks of frozen sediments located within the landslide debris material were traced back to crown of the landslide. The, Móafellshyrna debris slide fell on the 20th of September 2012, occurred after an unusually warm and dry summer with record amount of sunshine hours, followed by month of intense precipitation and earthquake activity in N-Iceland. The slide originated in a 200 m wide cirque at 750 m height in the NW slope of the mountain where a frozen solid debris cone slid or crept off a 100 m high rock face into a steep water saturated talus slope. The frozen sediments at 750 m height give clear indication of mountain permafrost in loose sediments at this altitude in the northern part of the Tröllaskagi peninsula. The primarily causes of these debris slide activity is primary thought to be related to precipitation. The thawing of the mountain permafrost can have played a significant role as a triggering factor, as demonstrated by large blocks of frozen sediments observed in the debris. Questions about the permafrost condition and possible decline of mountain permafrost have to be been addressed in relation to risk assessment. Reference: Sæmundsson, Þ., Arnalds, O., Kneisel, C., Jonsson, H.P. & Decaulne, A. 2012: The Orravatnsrústir Palsa site in central Iceland - Palsas in Eolian Sedimental Environment. Geomorphology 167-168, 14-20.

  16. Workshop on nuclear structure at moderate and high spin: Slide report

    SciTech Connect

    Not Available

    1986-10-01

    The workshop was scheduled to coincide with the beginning of operation of a number of large arrays of Compton-suppressed germanium detectors. The workshop was divided into 14 sessions containing 3 presentations each. The topics of these sessions were superdeformation, heavy rare earths, single-particle configurations, band termination, continuum properties, light rare-earths, new techniques, high temperatures, transfer reactions, transition region, shapes, lifetimes, and moments. This publication consists of the slides used in all of the presentations at the workshop.

  17. Sliding Mode Control of the X-33 with an Engine Failure

    NASA Technical Reports Server (NTRS)

    Shtessel, Yuri B.; Hall, Charles E.

    2000-01-01

    Ascent flight control of the X-3 is performed using two XRS-2200 linear aerospike engines. in addition to aerosurfaces. The baseline control algorithms are PID with gain scheduling. Flight control using an innovative method. Sliding Mode Control. is presented for nominal and engine failed modes of flight. An easy to implement, robust controller. requiring no reconfiguration or gain scheduling is demonstrated through high fidelity flight simulations. The proposed sliding mode controller utilizes a two-loop structure and provides robust. de-coupled tracking of both orientation angle command profiles and angular rate command profiles in the presence of engine failure, bounded external disturbances (wind gusts) and uncertain matrix of inertia. Sliding mode control causes the angular rate and orientation angle tracking error dynamics to be constrained to linear, de-coupled, homogeneous, and vector valued differential equations with desired eigenvalues. Conditions that restrict engine failures to robustness domain of the sliding mode controller are derived. Overall stability of a two-loop flight control system is assessed. Simulation results show that the designed controller provides robust, accurate, de-coupled tracking of the orientation angle command profiles in the presence of external disturbances and vehicle inertia uncertainties, as well as the single engine failed case. The designed robust controller will significantly reduce the time and cost associated with flying new trajectory profiles or orbits, with new payloads, and with modified vehicles

  18. Measurement of glucose concentration by image processing of thin film slides

    NASA Astrophysics Data System (ADS)

    Piramanayagam, Sankaranaryanan; Saber, Eli; Heavner, David

    2012-02-01

    Measurement of glucose concentration is important for diagnosis and treatment of diabetes mellitus and other medical conditions. This paper describes a novel image-processing based approach for measuring glucose concentration. A fluid drop (patient sample) is placed on a thin film slide. Glucose, present in the sample, reacts with reagents on the slide to produce a color dye. The color intensity of the dye formed varies with glucose at different concentration levels. Current methods use spectrophotometry to determine the glucose level of the sample. Our proposed algorithm uses an image of the slide, captured at a specific wavelength, to automatically determine glucose concentration. The algorithm consists of two phases: training and testing. Training datasets consist of images at different concentration levels. The dye-occupied image region is first segmented using a Hough based technique and then an intensity based feature is calculated from the segmented region. Subsequently, a mathematical model that describes a relationship between the generated feature values and the given concentrations is obtained. During testing, the dye region of a test slide image is segmented followed by feature extraction. These two initial steps are similar to those done in training. However, in the final step, the algorithm uses the model (feature vs. concentration) obtained from the training and feature generated from test image to predict the unknown concentration. The performance of the image-based analysis was compared with that of a standard glucose analyzer.

  19. An implicit sliding-motion preserving regularisation via bilateral filtering for deformable image registration.

    PubMed

    Papie?, Bart?omiej W; Heinrich, Mattias P; Fehrenbach, Jérome; Risser, Laurent; Schnabel, Julia A

    2014-12-01

    Several biomedical applications require accurate image registration that can cope effectively with complex organ deformations. This paper addresses this problem by introducing a generic deformable registration algorithm with a new regularization scheme, which is performed through bilateral filtering of the deformation field. The proposed approach is primarily designed to handle smooth deformations both between and within body structures, and also more challenging deformation discontinuities exhibited by sliding organs. The conventional Gaussian smoothing of deformation fields is replaced by a bilateral filtering procedure, which compromises between the spatial smoothness and local intensity similarity kernels, and is further supported by a deformation field similarity kernel. Moreover, the presented framework does not require any explicit prior knowledge about the organ motion properties (e.g. segmentation) and therefore forms a fully automated registration technique. Validation was performed using synthetic phantom data and publicly available clinical 4D CT lung data sets. In both cases, the quantitative analysis shows improved accuracy when compared to conventional Gaussian smoothing. In addition, we provide experimental evidence that masking the lungs in order to avoid the problem of sliding motion during registration performs similarly in terms of the target registration error when compared to the proposed approach, however it requires accurate lung segmentation. Finally, quantification of the level and location of detected sliding motion yields visually plausible results by demonstrating noticeable sliding at the pleural cavity boundaries. PMID:24968741

  20. Quantitative measurements of sliding friction coefficients of tribological interfaces with a new differential infrared radiometric instrument

    E-print Network

    Mandelis, Andreas

    Quantitative measurements of sliding friction coefficients of tribological interfaces with a new sliding friction coefficient SFC measurements using a mechanical friction rig and infrared radiometric. INSTRUMENTAL DESIGN FOR SLIDING FRICTION COEFFICIENT MEASUREMENTS Figure 1 is an overview of the differential

  1. 8. Photocopy of original USRS glass plate slide (from original ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    8. Photocopy of original USRS glass plate slide (from original slide on file at National Archives, Rocky Mountain Region, Denver, Colorado) Photographer unknown, ca. 1908 The diversion weir of the Okanogan National Irrigation Project - Salmon Creek Diversion Dam, Salmon Creek, Okanogan, Okanogan County, WA

  2. Single projector accommodates slides of different size and format

    NASA Technical Reports Server (NTRS)

    Gates, G. M.

    1966-01-01

    Projector with two adjustable external units accommodates slides of different size and format. One external unit is the holder for different size slides and includes mounting means for appropriate condensing lens and heat filters. The other unit is a turret lens assembly. The machine is easily adaptable to rear-screen and front-screen projection over various distances.

  3. Stress field at a sliding frictional contact: Experiments and calculations

    E-print Network

    Adda-Bedia, Mokhtar

    Stress field at a sliding frictional contact: Experiments and calculations J. Scheibert Ã,1 , A and tangential stress fields at the base of a rough elastomer film in contact with a smooth glass cylinder in steady sliding. This geometry allows for a direct comparison between the stress profiles measured along

  4. Lecture Handouts of Projected Slides in a Medical Course.

    ERIC Educational Resources Information Center

    Amato, Dominick; Quirt, Ian

    1991-01-01

    In a third-year medical school hematology course, handouts reproducing all or most of the 35mm slides used during the lecture are given at the beginning of class. The slides are reproduced on the left, with room for note-taking on the right. Despite some disadvantages, the method is seen as helpful. (Author/MSE)

  5. 49 CFR 229.115 - Slip/slide alarms.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... remote control, the wheel slip/slide alarm of each locomotive shall be shown in the cab of the... road service, or continue in road service following a daily inspection, unless the wheel slip/slide protective device of whatever type— (1) Is functioning for each powered axle under power; and (2)...

  6. 49 CFR 229.115 - Slip/slide alarms.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... remote control, the wheel slip/slide alarm of each locomotive shall be shown in the cab of the... road service, or continue in road service following a daily inspection, unless the wheel slip/slide protective device of whatever type— (1) Is functioning for each powered axle under power; and (2)...

  7. SlidingCoin Puzzles Erik D. Demaine Martin L. Demaine #

    E-print Network

    Demaine, Erik

    Sliding­Coin Puzzles Erik D. Demaine Martin L. Demaine # In what ways can an arrangement of coins coins? Martin Gardner publicized this family of sliding­coin puzzles (among others) in 1966. Recently, a general form of such puzzles was solved both mathematically and algorithmically. We describe the known

  8. 8 IEEE INTELLIGENT SYSTEMS Sliding-tile puzzles and Rubik's

    E-print Network

    Littman, Michael L.

    8 IEEE INTELLIGENT SYSTEMS Sliding-tile puzzles and Rubik's Cube in AI research Richard E. Korf, University of California, Los Angeles The best-known sliding-tile puzzle is the Fifteen Puzzle, shown in Figure 1a. Other sizes include the 3 × 3 Eight Puzzle and the 5 × 5 Twenty-Four Puzzle. The standard 3

  9. Tempest:ASubstrateforPortableParallelProgramsSlide Tempest:ASubstratefor

    E-print Network

    Lipasti, Mikko H.

    Tempest:ASubstrateforPortableParallelProgramsSlide 1 Tempest:ASubstratefor Portable(DE- FG02-93ER25176),UWGradSchool,WARF,BellLabs,DEC,Sun,TMC&Xerox #12;Tempest;Tempest:ASubstrateforPortableParallelPrograms WisconsinWindTunnelProject Slide 3 Not

  10. A Transformational Approach to Slip-Slide Factoring

    ERIC Educational Resources Information Center

    Steckroth, Jeffrey

    2015-01-01

    In this "Delving Deeper" article, the author introduces the slip-slide method for solving Algebra 1 mathematics problems. This article compares the traditional method approach of trial and error to the slip-slide method of factoring. Tools that used to be taken for granted now make it possible to investigate relationships visually,…

  11. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION CHILD CARE AND DEVELOPMENT FUND Program Operations (Child Care Services)-Lead Agency and Provider Requirements § 98.42 Sliding fee scales... provides for cost sharing by families that receive CCDF child care services. (b) A sliding fee...

  12. AFRD WAREHOUSE, WEST SIDE DETAIL OF ALTERED SLIDING DOORS, FACING ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    AFRD WAREHOUSE, WEST SIDE DETAIL OF ALTERED SLIDING DOORS, FACING EAST. WEATHER COVER OVER RAIL IS ORIGINAL. SHEET METAL SIDING HAS BEEN INSERTED BETWEEN TWO HALVES OF SLIDING DOORS. - Minidoka Relocation Center Warehouse, 111 South Fir Street, Shoshone, Lincoln County, ID

  13. Return to ranger submarine slide, Baja California, Mexico

    USGS Publications Warehouse

    Normark, W.R.

    1990-01-01

    Ranger Slide is a modest (12 km3) slide deposit of Pliocene and younger sediment on the continental slope in northern Sebastian Vizcaino Bay, Mexico. A limited survey using a deeply-towed instrument shows that hummocky terrain immediately downslope from the slide scar consists of large blocks of semiconsolidated sediment, some exceeding a kilometer in length and 107 m3 in volume. Most blocks have rotated, fallen apart, and/or deformed during movement. The form, structure, and processes related to emplacement of the blocks within the hummocky topographic zone of Ranger Slide may be common to many submarine slides on slopes involving semiconsolidated, terrigenous sediment. ?? 1990 Springer-Verlag New York Inc.

  14. A Communication Device for Interfacing Slide/Audio Tape Programs with the Microcomputer for Computer-Assisted Self-Instruction.

    ERIC Educational Resources Information Center

    Hostetler, Jerry C.; Englert, Duwayne C.

    1987-01-01

    Presents description of an interface device which ties in microcomputers and slide/tape presentations for computer assisted instruction. Highlights include the use of this technology in an introductory undergraduate zoology course; a discussion of authoring languages with emphasis on SuperPILOT; and hardware and software design for the interface.…

  15. High-throughput screening of FDA-approved drugs using oxygen biosensor plates reveals secondary mitofunctional effects.

    PubMed

    Sahdeo, Sunil; Tomilov, Alexey; Komachi, Kelly; Iwahashi, Christine; Datta, Sandipan; Hughes, Owen; Hagerman, Paul; Cortopassi, Gino

    2014-07-01

    Repurposing of FDA-approved drugs with effects on mitochondrial function might shorten the critical path to mitochondrial disease drug development. We improved a biosensor-based assay of mitochondrial O2 consumption, and identified mitofunctional defects in cell models of LHON and FXTAS. Using this platform, we screened a 1600-compound library of clinically used drugs. The assay identified drugs known to affect mitochondrial function, such as metformin and decoquinate. We also identified several drugs not previously known to affect mitochondrial respiration including acarbose, metaraminol, gallamine triethiodide, and acamprosate. These previously unknown 'mitoactives' represent novel links to targets for mitochondrial regulation and potentially therapy, for mitochondrial disease. PMID:25034306

  16. High-throughput screening of FDA-approved drugs using oxygen biosensor plates reveals secondary mitofunctional effects

    PubMed Central

    Sahdeo, Sunil; Tomilov, Alexey; Komachi, Kelly; Iwahashi, Christine; Datta, Sandipan; Hughes, Owen; Hagerman, Paul; Cortopassi, Gino

    2014-01-01

    Repurposing of FDA-approved drugs with effects on mitochondrial function might shorten the critical path to mitochondrial disease drug development. We improved a biosensor-based assay of mitochondrial O2 consumption, and identified mitofunctional defects in cell models of LHON and FXTAS. Using this platform, we screened a 1600-compound library of clinically used drugs. The assay identified drugs known to affect mitochondrial function, such as metformin and decoquinate. We also identified several drugs not previously known to affect mitochondrial respiration including acarbose, metaraminol, gallamine triethiodide, and acamprosate. These previously unknown ‘mitoactives’ represent novel links to targets for mitochondrial regulation and potentially therapy, for mitochondrial disease. PMID:25034306

  17. Catastrophic sliding bifurcations and onset of oscillations in a superconducting resonator.

    PubMed

    Jeffrey, M R; Champneys, A R; di Bernardo, M; Shaw, S W

    2010-01-01

    This paper presents a general analysis and a concrete example of the catastrophic case of a discontinuity-induced bifurcation in so-called Filippov nonsmooth dynamical systems. Such systems are characterized by discontinuous jumps in the right-hand sides of differential equations across a phase space boundary and are often used as physical models of stick-slip motion and relay control. Sliding bifurcations of periodic orbits have recently been shown to underlie the onset of complex dynamics including chaos. In contrast to previously analyzed cases, in this work a periodic orbit is assumed to graze the boundary of a repelling sliding region, resulting in its abrupt destruction without any precursive change in its stability or period. Necessary conditions for the occurrence of such catastrophic grazing-sliding bifurcations are derived. The analysis is illustrated in a piecewise-smooth model of a stripline resonator, where it can account for the abrupt onset of self-modulating current fluctuations. The resonator device is based around a ring of NbN containing a microbridge bottleneck, whose switching between normal and super conducting states can be modeled as discontinuous, and whose fast temperature versus slow current fluctuations are modeled by a slow-fast timescale separation in the dynamics. By approximating the slow component as Filippov sliding, explicit conditions are derived for catastrophic grazing-sliding bifurcations, which can be traced out as parameters vary. The results are shown to agree well with simulations of the slow-fast model and to offer a simple explanation of one of the key features of this experimental device. PMID:20365452

  18. Catastrophic sliding bifurcations and onset of oscillations in a superconducting resonator

    NASA Astrophysics Data System (ADS)

    Jeffrey, M. R.; Champneys, A. R.; di Bernardo, M.; Shaw, S. W.

    2010-01-01

    This paper presents a general analysis and a concrete example of the catastrophic case of a discontinuity-induced bifurcation in so-called Filippov nonsmooth dynamical systems. Such systems are characterized by discontinuous jumps in the right-hand sides of differential equations across a phase space boundary and are often used as physical models of stick-slip motion and relay control. Sliding bifurcations of periodic orbits have recently been shown to underlie the onset of complex dynamics including chaos. In contrast to previously analyzed cases, in this work a periodic orbit is assumed to graze the boundary of a repelling sliding region, resulting in its abrupt destruction without any precursive change in its stability or period. Necessary conditions for the occurrence of such catastrophic grazing-sliding bifurcations are derived. The analysis is illustrated in a piecewise-smooth model of a stripline resonator, where it can account for the abrupt onset of self-modulating current fluctuations. The resonator device is based around a ring of NbN containing a microbridge bottleneck, whose switching between normal and super conducting states can be modeled as discontinuous, and whose fast temperature versus slow current fluctuations are modeled by a slow-fast timescale separation in the dynamics. By approximating the slow component as Filippov sliding, explicit conditions are derived for catastrophic grazing-sliding bifurcations, which can be traced out as parameters vary. The results are shown to agree well with simulations of the slow-fast model and to offer a simple explanation of one of the key features of this experimental device.

  19. David Douglas Duncan's Changing Views on War: An Audio-Visual Presentation.

    ERIC Educational Resources Information Center

    Politowski, Richard

    This paper is the script for a slide presentation about photographer David Douglas Duncan and his view of war. It is intended to be used with slides made from pictures Duncan took during World War II, the Korean War, and the war in Viet Nam and published in various books and periodicals. It discusses a shift in emphasis to be seen both in the…

  20. Sliding Mode Control of Steerable Needles.

    PubMed

    Rucker, D Caleb; Das, Jadav; Gilbert, Hunter B; Swaney, Philip J; Miga, Michael I; Sarkar, Nilanjan; Webster, Robert J

    2013-10-01

    Steerable needles can potentially increase the accuracy of needle-based diagnosis and therapy delivery, provided they can be adequately controlled based on medical image information. We propose a novel sliding mode control law that can be used to deliver the tip of a flexible asymmetric-tipped needle to a desired point, or to track a desired trajectory within tissue. The proposed control strategy requires no a priori knowledge of model parameters, has bounded input speeds, and requires little computational resources. We show that if the standard nonholonomic model for tip-steered needles holds, then the control law will converge to desired targets in a reachable workspace, within a tolerance that can be defined by the control parameters. Experimental results validate the control law for target points and trajectory following in phantom tissue and ex vivo liver. Experiments with targets that move during insertion illustrate robustness to disturbances caused by tissue deformation. PMID:25400527