Science.gov

Sample records for fda presentation slides

  1. SSP: Sketching Slide Presentations, a Syntactic Approach

    NASA Astrophysics Data System (ADS)

    Mas, Joan; Sanchez, Gemma; Lladós, Josep

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

  2. An Easy Method for Preparing Presentation Slides.

    ERIC Educational Resources Information Center

    Wright, Norman A.; Blevins, Dennis D.

    1984-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Cooper, Matthew

    2013-03-01

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

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

    ERIC Educational Resources Information Center

    Hunt, Harold R., Jr.

    1985-01-01

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

  5. Robust spatiotemporal matching of electronic slides to presentation videos.

    PubMed

    Fan, Quanfu; Barnard, Kobus; Amir, Arnon; Efrat, Alon

    2011-08-01

    We describe a robust and efficient method for automatically matching and time-aligning electronic slides to videos of corresponding presentations. Matching electronic slides to videos provides new methods for indexing, searching, and browsing videos in distance-learning applications. However, robust automatic matching is challenging due to varied frame composition, slide distortion, camera movement, low-quality video capture, and arbitrary slides sequence. Our fully automatic approach combines image-based matching of slide to video frames with a temporal model for slide changes and camera events. To address these challenges, we begin by extracting scale-invariant feature-transformation (SIFT) keypoints from both slides and video frames, and matching them subject to a consistent projective transformation (homography) by using random sample consensus (RANSAC). We use the initial set of matches to construct a background model and a binary classifier for separating video frames showing slides from those without. We then introduce a new matching scheme for exploiting less distinctive SIFT keypoints that enables us to tackle more difficult images. Finally, we improve upon the matching based on visual information by using estimated matching probabilities as part of a hidden Markov model (HMM) that integrates temporal information and detected camera operations. Detailed quantitative experiments characterize each part of our approach and demonstrate an average accuracy of over 95% in 13 presentation videos. PMID:21292597

  6. Laboratory Slide Presentations: A Means of Saving Faculty Time.

    ERIC Educational Resources Information Center

    Wiechel, John; And Others

    1981-01-01

    Describes a slide presentation method for preparing graduate students as lab instructors for engineering courses. The course may not only reduce faculty training time but also provides continuity in quality and content of instruction. (DS)

  7. Environmental radiation standards. [Outline of slide presentation

    SciTech Connect

    Kocher, D.C.

    1987-01-01

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

  8. 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…

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

    ERIC Educational Resources Information Center

    World Resources Inst., Washington, DC.

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

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  11. 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…

  12. 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.

  13. Effects of Varied Temporal Visual Overlapping in Multi-Image Tape-Slide Presentations

    ERIC Educational Resources Information Center

    Owens, R. David; Coldevin, Gary O.

    1977-01-01

    This study compares three multi-stage versions of a tape-slide presentation with a parallel single image format. Multi-image treatments differed in the amount of time two images were simultaneously in view. (Author)

  14. SLIDE PRESENTATION ON EMSP PROJECT 65328: ELECTRICALLY DRIVEN TECHNOLOGIES FOR RADIOACTIVE AEROSOL ABATEMENT

    EPA Science Inventory

    These are the Powerpoint slides from a presentation on electrically driven technologies for radioactive aerosol abatement. The overall objectives of this project were:(1) to generate a scientific basis for developing innovative electrically based filtration systems that are appl...

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

    EPA Science Inventory

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

  16. 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.

  17. 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.

  18. 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…

  19. 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…

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  2. Tips for giving a memorable presentation, Part IV: Using and composing PowerPoint slides.

    PubMed

    Harolds, Jay A

    2012-10-01

    Visual aids such as PowerPoint slides can be helpful or deleterious to the quality of the talk, depending on how they are done and how they are used. This article will discuss ways to optimize the composition of PowerPoint presentations. This includes the appropriate composition of word slides and the use of the right font size and style of letters. It also includes tips in the use of color, special effects, and graphs. Pointers on how to properly anonymize patient images are also given. PMID:22899205

  3. Database Program To Manage Slides and Images for Teaching and Presentations.

    ERIC Educational Resources Information Center

    Byers, John A.

    1999-01-01

    Describes a computer program that manages a collection of pictures such as photographic slides, overheads, or computer images in one or more databases. Discusses organizing the database, searching, and keeping track of the time needed to present the images. (Author/LRW)

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

    ERIC Educational Resources Information Center

    Hardesty, Larry

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

  5. Drugs@FDA: FDA Approved Drug Products

    MedlinePLUS

    ... A to Z Index Follow FDA En Espańol Enter Search terms Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs@FDA: FDA Approved Drug ... Search by Drug Name, Active Ingredient, or Application Number Enter at least three characters: Advanced Search Browse by ...

  6. FDA Certified Mammography Facilities

    MedlinePLUS

    ... HHS U.S. Department of Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to Z Index Follow FDA En Español Search FDA Submit search Popular Content ...

  7. 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 ...

  8. 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…

  9. Teacher Education Students' Perceptions of the Value of Handouts Accompanying Teacher Educators' Computer-Generated Slide Presentations

    ERIC Educational Resources Information Center

    Yilmazel-Sahin, Yesim; Oxford, Rebecca L.

    2010-01-01

    This mixed-methods study used interviews and a questionnaire to investigate the perceptions of 304 teacher education students regarding the learning-related value of handouts accompanying teacher educators' computer-generated slide presentations. The extent to which graduate and undergraduate students differed in their perceptions was also…

  10. Introduction to the Newspaper. A Teacher's Guide for Slide and Transparency Presentations.

    ERIC Educational Resources Information Center

    Makuka, Kathleen D.

    The Teacher's guide contains seven lesson plans integrating slides and transparencies with other class activities to provide knowledge and understanding of the newspaper. The lesson topics are: the four purposes of the newspaper, fact and opinion, the front page, basic structure of news story, the blind ad and the public ad, the novelty lead, and…

  11. Is It Really FDA Approved?

    MedlinePLUS

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

  12. FDA -- 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

  13. 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.

  14. FDA 101: Dietary Supplements

    MedlinePLUS

    ... common links HHS U.S. Department of Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health ... Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical ... Products Tobacco Products Vaccines, Blood & Biologics ...

  15. 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 ...

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

    ERIC Educational Resources Information Center

    Sathiyamurthy, K.; Geetha, T. V.

    2012-01-01

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

  17. 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…

  18. Career Exploration Via Slides

    ERIC Educational Resources Information Center

    Myhra, Cheryl

    1973-01-01

    Bringing the world of work into the classroom may be facilitated by means of a teacher-prepared slide presentation. Suggestions for 75 slides depicting various occupations and commentary to accompany them provide guidelines for teachers wishing to develop their own collection of slides. (AG)

  19. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale. PMID:26027494

  20. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

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

  1. FDA-Approved HIV Medicines

    MedlinePLUS

    HIV Treatment FDA-Approved HIV Medicines (Last updated 3/15/2016; last reviewed 3/1/2016) Treatment with HIV medicines is ... approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the ...

  2. 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…

  3. 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. PMID:26374073

  4. FDA Monitoring Program.

    PubMed

    1993-01-01

    Under regulatory monitoring, 16,428 samples of domestically produced and imported food from 94 countries were analyzed for pesticide residues in 1992. Of these, 15,370 were surveillance samples, which are collected when there is no evidence of a pesticide problem. No residues were found in 65% of the domestic surveillance samples and 66% of the import surveillance samples. Findings in the 1058 compliance samples reflect their collection and analysis when a pesticide problem is suspected. Under incidence/level monitoring, 206 samples of aquaculture seafood/shellfish and 558 milk samples were analyzed for pesticide residues. The findings were similar to those from FDA's regulatory monitoring. The 1986-1991 Total Diet Study average results (dietary intake of pesticides) over that period are generally well below the standards set by the JMPR and by EPA. These 5-year averages may differ from the previously reported 1-year intakes (6-10) because they cover a period during which intakes of some chemicals, such as persistent chlorinated pesticides, have been generally declining, and also because they represent a 5-year rather than a 1-year average. PMID:8241821

  5. 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.

  6. FDA-Approved Biosimilar Insulin

    PubMed Central

    2014-01-01

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

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

    PubMed

    O'Reilly, James T

    2009-01-01

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

  8. Slide Classification and Cataloging.

    ERIC Educational Resources Information Center

    Clawson, Catherine R.; Ronkowski, Charles A.

    1981-01-01

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

  9. 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…

  10. FDA board investigates Depo-Provera safety.

    PubMed

    1983-03-01

    For 1 week a drug company's representatives, officials from the US Food and Drug Administration (FDA), and other interested individuals debated whether Depo-Provera (medroxyprogesterone acetate or DMPA) can be safely used, but they failed to resolve the issues. "Contraceptive Technology Update" attended these hearings and interviewed witnesses to bring its readers a comprehensive report on the issues. 9 articles summarize the presentations at he hearing. The FDA public board of inquiry sought to resolve the following issues concerning Depo-Provera: in comparison with other contraceptive drugs, do the benefits outweigh the risks; do data from animal studies indicate a potential risk of breast or endometrial cancer in humans from Depo-Provera; can the human studies' data refute the risk of human cancer suggested by the animal data; are there labeling conditions and distribution controls that would permit marketing of Depo-Provera as a safe and effective drug on a limited basis; would marketing approval of Depo-Provera as a contraceptive increase the use of the drug under conditions not stipulated in the approval; does use of Depo-Provera increase the risk of teratogenic effects to a greater extent than other systemic contraceptives in the event of a failure; and is estrogen therapy likely to be prescribed for a significant number of patients using Depo-Provera. The issues raised have blocked marketing of Depo-Provera as a contraceptive in the US for a number of years. In 1968 the Upjohn Company began the lengthly process for having a drug approved for use in the US by filing with the FDA a New Drug Application (NDA) for Depo-Provera's use as a contraceptive. Although Depo-Provera has not been approved for use in the US, Upjohn manufactures the contraceptive in Belgium and France and estimates that more than a million women in 80 countries use the contraceptive. DMPA is still approved as adjunctive therapy for metastatic endometrial carcinoma and renal carcinoma. Because of that approved use, the drug has reportedly been prescribed as a contraceptive in this country, contrary to its current label indications. The FDA's obstetrics and gynecology advisory committee recommended approval of Depo-Provera in 1975, but the Public Citizen Health Research Group and some congressmen asked that the FDA not approve the drug. In 1978 the FDA notified Upjohn that its NDA would not be approved. Upjohn then requested a hearing in the form of a Public Board of Inquiry. The board held the hearing in January 1983. The controversy over Depo-Provera involves noted groups and individuals on both sides. PMID:12266161

  11. FDA's perspectives on cardiovascular devices.

    PubMed

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

    2009-06-01

    The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial. PMID:20559979

  12. Newly Designed Endoscope Receives FDA Approval

    MedlinePLUS

    ... news/fullstory_156727.html Newly Designed Endoscope Receives FDA Approval Manufacturer made changes to reduce risk of ' ... to reduce the risk of bacterial infections, the FDA said. The original model will be recalled and ...

  13. Mifepristone approval delayed, supporters look to action by FDA.

    PubMed

    2000-05-01

    Although the US Food and Drug Administration (FDA) has again delayed action on marketing approval of the abortion drug mifepristone, supporters are using the time to continue provider training, education, and research of the medical abortion option. While FDA says it needs more information before reaching a decision on whether the drug will be made available in the US, it issued an approval letter on the mifepristone/misoprostol drug regimen, which echoed its original action of September 18, 1996. An approval letter is an action frequently used by the FDA to indicate that safety and efficacy data have passed agency review but additional information must be submitted before final approval for marketing is given. While the FDA approval process is moving forward, the National Abortion Federation (NAF) has held 12 provider training sessions this year, with presentations scheduled at several national professional provider organizations. NAF is also developing educational materials on mifepristone for patients and providers. PMID:12295903

  14. 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)

  15. Slide system for machine tools

    DOEpatents

    Douglass, Spivey S.; Green, Walter L.

    1982-01-01

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

  16. 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.

  17. 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......

  18. 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.

  19. US FDA perspective on regulatory issues affecting circulatory assist devices.

    PubMed

    Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

    2006-11-01

    There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue. PMID:17280539

  20. 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…

  1. 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.

  2. 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…

  3. Current FDA directives for promoting public health

    SciTech Connect

    Hayes, A.H. Jr.

    1982-03-01

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

  4. Appearance Normalization of Histology Slides

    NASA Astrophysics Data System (ADS)

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

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

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

    PubMed

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

    2012-12-01

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

  6. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... In the February 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing..., FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee... Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for...

  7. FDA Finalizes New Food Safety Rules

    MedlinePLUS

    ... rules are meant to prevent." The establishment of regulations changes the FDA's mission from reacting to outbreaks of foodborne illness to making the food industry responsible for preventing them, Taylor said. The new ...

  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 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 ...

  10. 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.

  11. Recalls. FDA, industry cooperate to protect consumers.

    PubMed

    Nordenberg, T

    1995-10-01

    When a marketed product is found to violate the law, more often than not it's the company that removes it from the market--or recalls it in FDA lingo. This helps the companies, taxpayers and consumers. PMID:10151838

  12. Appearance normalization of histology slides.

    PubMed

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

    2015-07-01

    This paper presents a method for automatic color and intensity normalization of digitized histology slides stained with two different agents. In comparison to previous approaches, prior information on the stain vectors is used in the plane estimation process, resulting in improved stability of the estimates. Due to the prevalence of hematoxylin and eosin staining for histology slides, the proposed method has significant practical utility. In particular, it can be used as a first step to standardize appearance across slides and is effective at countering effects due to differing stain amounts and protocols and counteracting slide fading. The approach is validated against non-prior plane-fitting using synthetic experiments and 13 real datasets. Results of application of the method to adjustment of faded slides are given, and the effectiveness of the method in aiding statistical classification is shown. PMID:25863518

  13. 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.

  14. 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

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

  15. 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... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

  16. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

  17. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a)...

  18. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or...

  19. 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... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

  20. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or...

  1. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

  2. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

  3. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a)...

  7. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a)...

  10. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1)...

  11. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or...

  12. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a)...

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

    NASA Astrophysics Data System (ADS)

    Baleanu, Dumitru; Tenreiro Machado, J. A.

    2009-10-01

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

  15. Epidural steroid warning controversy still dogging FDA.

    PubMed

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

    2014-01-01

    On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence. PMID:25054397

  16. 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

  17. 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.

  18. FDA Approves Expanded Use for Melanoma Drug

    MedlinePLUS

    ... the FDA approved a first-of-a-kind therapy called Imlygic (talimogene laherparepvec) for melanoma. It's a genetically engineered cold sore virus that "blows up" melanoma tumors. The U.S. National Cancer Institute estimates that about 74,000 new cases ...

  19. 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

  20. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

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

  1. FDA Warns of Lead Poisoning Risk from Cosmetic Clay

    MedlinePLUS

    ... nlm.nih.gov/medlineplus/news/fullstory_156980.html FDA Warns of Lead Poisoning Risk From Cosmetic Clay ... com and Sally Beauty Supply, according to the FDA. Alikay Naturals' website claims that the clay purifies ...

  2. FDA Tightens Rules for Using Mesh Implants in Women's Surgery

    MedlinePLUS

    ... nlm.nih.gov/medlineplus/news/fullstory_156510.html FDA Tightens Rules for Using Mesh Implants in Women's ... now submit pre-market approval applications to the FDA to help the agency better assess the implants' ...

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

    PubMed

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

    2014-06-01

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

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

    MedlinePLUS

    ... 888-463-6332) Contact FDA Subscribe to FDA RSS feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International ...

  5. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  6. 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...

  7. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office...

  8. 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... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  9. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  10. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  11. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office...

  12. 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... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  13. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  14. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  15. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  16. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the...

  17. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  18. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office...

  19. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  20. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA assistance on eligibility. 60.10 Section 60.10... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office...

  1. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  2. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  3. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  4. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  5. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  6. 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...

  7. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  8. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have...

  9. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  10. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  11. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the...

  12. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  13. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false FDA recognition of exclusive approval. 316.34... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable)...

  14. 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... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office...

  15. 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.

  16. Secondary Reverse Slide Tracheoplasty for Airway Rescue.

    PubMed

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

    2016-03-01

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

  17. ADHD Medication Use Following FDA Risk Warnings

    PubMed Central

    Barry, Colleen L.; Martin, Andres; Busch, Susan H.

    2013-01-01

    Background In 2006, the U.S. Food and Drug Administration (FDA) investigated cardiac and psychiatric risks associated with attention deficit/hyperactivity disorder (ADHD) medication use. Aims of the Study To examine how disclosure of safety risks affected pediatric ADHD use, and to assess news media coverage of the issue to better understand trends in treatment patterns. Methods We used the AHRQ’s Medical Expenditure Panel Survey (MEPS), a nationally representative household panel survey, to calculate unadjusted rates of pediatric ADHD use from 2002 to 2008 overall and by parents’ education. We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use. Results No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medication use by children. Discussion ADHD risk warnings were not associated with large declines in medication use, and balanced news coverage may have contributed to the treatment patterns observed. Self-reported surveys like the MEPS rely on the recall of respondents and may be subject to reporting bias. However, the validity of these data is supported by their consistency with other data on drug use from other sources. Implications for Health Care Provision and Use These findings are in direct contrast to the substantial declines in use observed after pediatric antidepressant risk warnings in the context of a news media environment that emphasized risks over benefits. Implications for Health Policies Our findings are relevant to the ongoing discussion about improving the FDA’s ability to monitor drug safety. Safety warnings occur amid ongoing concern that the agency has insufficient authority and resources to fulfill its mission to protect the public’s health. Efforts to bolster the FDA’s postmarketing surveillance system have the potential to incorporate more data in decision making to allow for earlier detection of health risks. Implications for Further Research Further research is needed to assess whether other treatment changes occurred following risk warnings. For example, it is important to determine whether an increase in cardiac screening prior to medication initiation occurred. Likewise, the FDA advises that children experiencing hallucinations or other psychiatric responses to medication be discontinued from drug treatment. If it is determined that instead of being discontinued from medication treatment, children experiencing hallucinations are put on additional medication (e.g., antipsychotics), additional efforts by the FDA to better inform the public are warranted. PMID:23001280

  18. RU 486, the FDA and free enterprise.

    PubMed

    Buc, N L

    1992-01-01

    The legal question whether RU-486 can meet the standards for US Food and Drug Administration (FDA) approval for a drug indicated for abortion can be answered in the affirmative. Under the Food, Drug, and Cosmetic Act, efficacy must be demonstrated by evidence consisting of adequate and well-controlled investigations to show that a drug is safe and effective for its intended use. The FDA will approve it if on the basis of the clinical trials it could be concluded that the drug will have the effect it purports as prescribed in the labeling, and if the drug is safe. In congressional hearings and in the newspapers the so-called import alert issued by the FDA to prevent the importing of RU-486 under certain circumstances has been publicized. The import alert is no bar to conducting clinical studies in the US under an investigational new drug application (IND) nor is the import alert a bar to the filing and the pursuit of a new drug application (NDA) to allow marketing in the US. The import alert is no bar to anything except importation without an IND or NDA. The real problem is that there is no seller of RU-486 in the US and no sponsor of an NDA offering clinical evidence of safety and efficacy as well as the ability to manufacture the drug and the necessary prostaglandins properly. In additions to abortion, other uses of RU-486 include contraception, breast cancer, and Cushing syndrome. Some limited research could be done under INDs with small supplies of the drug obtained elsewhere on the world market. There are only 2 solutions to this problem. One is that Roussel must change its mind or have its mind changed as the example of the AIDS community showed, which has managed to induce the development of drugs that were impossible 8 or 10 years ago. The other solution is to found a pharmaceutical company that could induce competition for manufacturing RU-486. PMID:1434765

  19. Combination products regulation at the FDA.

    PubMed

    Lauritsen, K J; Nguyen, T

    2009-05-01

    The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, and medical devices. As single-entity products, drugs are generally regulated by the Center for Drug Evaluation and Research (CDER), devices by the Center for Devices and Radiological Health (CDRH), and biologics by the Center for Biologics Evaluation and Research (CBER). In recent years, technological advances have led to a blurring of the historical lines of separation between the centers. PMID:19381151

  20. Peat slides and rain fall intensities

    NASA Astrophysics Data System (ADS)

    Carroll, Roselyn; Long, Mike

    2010-05-01

    The objective of this work is to assess the reasons for peat bog slides in upland areas of Ireland and to provide tools for susceptibility assessment of future slides. A case study of a recent peat slide in Ireland will be presented in order to address these objectives. The slide occurred on the 23rd August 2009 north of Glencolmcille, Co. Denegal in an upland blanket bog. The interaction of groundwater, rainfall, and human activities in peat areas are all considered casual factors that impact on the stability of peat. An understanding of these factors combined with the shear strength of peat will help in assessing the risks of peat slope failures. Rainfall from previous years and at the time of the slide, peat shear strength and known human activities at the slide location will be assed and a description of the slide will be presented. Boylan et al. (2008) noted that the most commonly cited casual factor for peat slope failures was periods of incense or prolonged rainfall. Basic geotechnical properties of the peat sampled at different depths will be presented. A shear strength profile of peat at the location of the slide will be developed using direct simple shear (DSS) tests. The shear strength results from DSS tests will be implemented in a limit state slope stability model for the slide location so as to back calculate the existing slide and then could be used in a risk assessment of a peat slide. Boylan, N., Jennings, P. & Long, M. (2008) Peat slope failure in Ireland. Quarterly Journal of Engineering Geology and Hydrogeology, 41(1), 93-108.

  1. 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…

  2. Classification and Cataloging of Slides Using Color Photocopying

    ERIC Educational Resources Information Center

    Clawson, Catherine R.; Rankowski, Charles A.

    1978-01-01

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

  3. Classification and Cataloging of Slides Using Color Photocopying

    ERIC Educational Resources Information Center

    Clawson, Catherine R.; Rankowski, Charles A.

    1978-01-01

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

  4. Automatic extraction of drug indications from FDA drug labels.

    PubMed

    Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong

    2014-01-01

    Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs. PMID:25954385

  5. FDA reform. Food and Drug Administration.

    PubMed

    Agosto, M

    1995-01-01

    During the 104th Congress, proposals have been made to make changes to the regulations of the Food and Drug Administration (FDA), the agency that regulates foods and drugs sold to consumers. Congress is considering eliminating some of the regulations over drug development, thereby hoping to encourage companies to be more cost effective and invest more on developing drugs. The current regulations are often burdensome and may take years to fulfill. In addition, it has been argued by some that many of the restrictions now in place limit the ability of businesses to make profits. By removing some of the unnecessary regulations, manufacturers will be more interested in investing in research and development to produce new drugs. NMAC warns that this should not detract from the need to protect individuals. NMAC's priorities are to preserve the necessary regulatory elements that would protect consumers, while still maintaining the desirable expedition of the drug approval process. PMID:11362453

  6. Ergometer rowing with and without slides.

    PubMed

    Holsgaard-Larsen, A; Jensen, K

    2010-12-01

    A rowing ergometer can be placed on a slide to imitate 'on-water' rowing. The present study examines I) possible differences in biomechanical and physiological variables of ergometer rowing with and without slides and II) potential consequences on training load during exercise. 7 elite oars-women rowed in a randomized order in a slide or stationary ergometer at 3 predefined submaximal and at maximal intensity. Oxygen uptake was measured and biomechanical variables of the rowing were calculated based upon handle force (force transducer) and velocity/length (potentiometer) of the stroke. Stroke frequency was higher (%-difference between conditions) at each intensity level (1-11.4%, p<0.05) during slide compared to stationary rowing. Furthermore, at the 2 highest intensities a lower mean force (4.7-9.0%, p<0.05) and max force (3.2-10.6%, p<0.05) were observed on the slide ergometer. During maximal rowing no difference was seen in heart rate, mean oxygen uptake and R-value while maximal oxygen deficit was higher (30.8%, p<0.05) during slide rowing. In conclusion the biomechanical load is lower on a slide than on a stationary ergometer. However, as a training tool the slide ergometer seems just as demanding with regard to aerobic energy sources, and for anaerobic sources possibly even higher, compared with the stationary ergometer. PMID:20827655

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

    SciTech Connect

    Hansen, E. K.

    2015-05-06

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

  8. The FDA's program for monitoring radionuclides in food

    SciTech Connect

    Baratta, E.J. )

    1992-01-01

    The US Food and Drug Administration (FDA) modified its food-monitoring program in 1973 to include radioactive isotopes. There was concern at this time about the possibility of food contamination by effluents from nuclear power plants, some above-ground weapons testing by nonsignatory powers, and increased use of medical and commercial radioactive materials. The FDA decided, therefore, that a radioanalytical capability must be maintained to detect any upward trend of radioactive contamination in food. This capability would also allow the FDA to respond to any incidents that might occur in order to protect the US food supply. This program is located at the FDA's Winchester Engineering and Analytical Center, Winchester, Massachusetts.

  9. Slide2Go: A virtual slide collection for pathology education.

    PubMed

    Conran, Richard; Fontelo, Paul; Liu, Fang; Fontelo, Marie; White, Elizabeth

    2007-01-01

    Slide2Go is a collection of digitized glass slides on the Web from a pathology departments slide set for second year medical students. The virtual slide collection can be accessed anywhere using any Web browser with Adobe Flash Player. It simulates the experience of viewing a glass slide under an optical microscope. Rare and unusual cases can be preserved and shared worldwide. Medical education can be enhanced by virtual slides. PMID:18694018

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

    PubMed Central

    GarcĂ­a-LĂłpez, Pablo; GarcĂ­a-MarĂ­n, 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

  11. Selected case from the Arkadi M. Rywlin International Pathology Slide Series: Mitochondrial myopathy presenting with chronic progressive external ophthalmoplegia (CPEO): a case report.

    PubMed

    Bisceglia, Michele; Crociani, Paola; Fogli, Danilo; Centola, Antonio; Galliani, Carlos A; Pasquinelli, Gianandrea

    2014-11-01

    A 43-year-old female patient diagnosed with chronic progressive external ophthalmoplegia (CPEO) because of mitochondrial myopathy documented by muscle biopsy is presented. The chief complaints were represented by blepharoptosis and ophthalmoplegia. The muscle biopsy was evaluated by histology, using the appropriate histochemical and histoenzimological stains. Ragged red fibers with Gomori trichrome stain were seen, which showed cytochrome c oxydase deficiency and abnormal succinate dehydrogenase staining in around 20% of muscle fibres. Electron microscopy was also performed which demonstrated abnormal, hyperplastic, pleomorphic, and hypertrophic mitochondria, characterized by paracrystalline inclusions arranged in parallel rows ("parking-lot" inclusions), consisting of rectangular arrays of mitochondrial membranes in a linear or grid-like pattern. In conclusion, mitochondrial myopathy was definitely diagnosed. Although molecular analysis, which was subsequently carried out, failed to reveal mutations in the mitochondrial DNA or in selected nuclear genes, the pathologic diagnosis was not changed. The differential diagnosis of CPEO with other forms of ocular myopathies as well as the possible association of CPEO with systemic syndromes is discussed. Ophtalmologists and medical internists should always suspect CPEO when dealing with patients affected by ocular myopathy, either in its pure form or in association with other myopathic or systemic signs. PMID:25299315

  12. Mailing microscope slides

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  13. Aerial View of Slide

    USGS Multimedia Gallery

    Aerial view of slide at Daly City. This is the largest slide triggered by the earthquake in San Mateo County, displacing approximately 36,700 cubic meters (48,000 cubic yards) of material. The base is about 152 me (500 ft) across at its widest point....

  14. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  15. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  16. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  17. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  18. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1110 FDA public information offices. (a) Division of Dockets Management....

  19. FDA monitoring program. Residues in foods--1990.

    PubMed

    Yess, N J

    1991-01-01

    In 1990, under regulatory monitoring, a total of 19,962 samples of domestically produced food from all 50 states and Puerto Rico and imported food from 92 countries were analyzed by FDA for pesticide residues. Of these, 19,146 were surveillance samples, which are collected when there is no suspicion of a pesticide problem. No residues were found in 60% of domestic surveillance samples and in 64% of import surveillance samples. Of the 19,146 surveillance samples, 2.8% were violative. Under the incidence/level aspect of monitoring, 172 samples of fish/shell-fish, 330 samples of whole milk, and 3502 samples of processed foods including baby foods were analyzed for pesticide residues. Findings from these projects were consistent with regulatory monitoring data. The findings of the 1990 Total Diet Study are evidence that actual dietary intakes of pesticides are generally well below the standards established by FAO/WHO and by EPA. The 1990 results are similar to those obtained in earlier years and demonstrate the continuing safety of the food supply relative to pesticide residues. PMID:1783581

  20. How should FDA regulate prescription drug promotion on the Internet?

    PubMed

    Opderbeck, D W

    1998-01-01

    The current scheme for regulating prescription drug labeling and advertising developed in a world in which information was centralized, static, and one-dimensional. Advertising was merely incidental to other activities such as reading magazines or watching programs. The Internet-wired world is different. Information is now instantly, globally accessible. Consumers can search through varied levels of detail on almost any topic. Anyone can join the fray by publishing their own materials on the Internet. This article addresses the unique problems raised by any proposed regulation of prescription drug labeling and advertising on the Internet. In particular, the article reviews the history, culture, technology, and popular uses of the Internet, and examines some of the models for regulation presented at an October 1996 Food and Drug Administration (FDA) conference on regulation of Internet content. Finally, the article suggests a new direction for regulation prescription drug promotion on the Internet. PMID:11795336

  1. Theory of rubber friction: Nonstationary sliding

    NASA Astrophysics Data System (ADS)

    Persson, B. N.; Volokitin, A. I.

    2002-04-01

    When rubber slides on a hard, rough substrate, the surface asperities of the substrate exert oscillating forces on the rubber surface leading to energy ``dissipation'' via the internal friction of the rubber. In this paper we extend an earlier published theory [B.N.J. Persson, J. Chem. Phys. 115, 3840 (2001)] to nonstationary sliding, and present a discussion of how the area of real contact and the friction force depend on the nature of the substrate surface roughness and on the history of the sliding motion. We consider in detail the case when the substrate surface has a self-affine fractal structure.

  2. 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.

  3. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

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

  4. Current FDA-approved treatments for Helicobacter pylori and the FDA approval process.

    PubMed

    Hopkins, R J

    1997-12-01

    U.S. Food and Drug Administration (FDA) approval of new drugs expands treatment options and serves as a "safety net" of well-documented efficacy and safety. The information provided in the package insert facilitates physician education and provides some assurance that marketing information is accurate. As of February 1997, three Helicobacter pylori regimes have been FDA-approved for eradication of H. pylori in infected patients with active duodenal ulcers. Regimen 1, omeprazole + clarithromycin (O/C), was supported by two multicenter, controlled studies with a 6-month follow-up. Eradication rates were 74% (n = 53; 95% confidence interval [CI], 62-85) and 64% (n = 61; 95% CI, 52-76). Twenty-five of 26 patients with failed eradication therapy who were taking O/C with clarithromycin-susceptible strains before treatment and who had pretreatment and posttreatment susceptibility tests performed developed clarithromycin resistance after treatment. Regimen 2, ranitidine-bismuth-citrate + clarithromycin, was supported by two multicenter, placebo-controlled studies with a 6-month follow-up. Eradication rates were 84% (n = 19; 95% CI, 60-96) and 73% (n = 22; 95% CI, 50-88). Insufficient pretreatment and posttreatment susceptibility data were collected to assess antimicrobial resistance. Regimen 3, bismuth subsalicylate + metronidazole + tetracycline + an H2-receptor antagonist, was supported by two pivotal literature-based studies. Eradication rates in patients with duodenal ulcer were 82% (n = 51; 95% CI, 70-92) and 77% (n = 39; 95% CI, 61-89), respectively. When extrapolating the results of these three FDA-approved regimens to the clinical setting, particular aspects of the clinical trial should be kept in mind. These include the type of controls, primary end points used, population studied, and number and type of dropouts. PMID:9394774

  5. Preparing Scientific Papers, Posters, and Slides.

    PubMed

    Lefor, Alan Kawarai; Maeno, Misato

    2016-01-01

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

  6. Ornamental Landscape Grasses. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven M.; Adams, Denise W.

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

  7. Ornamental Landscape Grasses. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven M.; Adams, Denise W.

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

  8. Fundamentals of the Slide Library.

    ERIC Educational Resources Information Center

    Boerner, Susan Zee

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

  9. Slides, Swings and Science.

    ERIC Educational Resources Information Center

    Dreyer, Kay Jardon; Bryte, Janelle

    1990-01-01

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

  10. 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!

  11. 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.

  12. FDA regulation of cardiovascular devices and opportunities for improvement.

    PubMed

    Dhruva, Sanket S; Redberg, Rita F

    2013-03-01

    Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA's pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists. PMID:23263896

  13. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... 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...

  14. FDA Approves Nasal Spray to Reverse Narcotic Painkiller Overdose

    MedlinePLUS

    ... A nasal spray that treats narcotic painkiller and heroin drug overdoses has been approved by the U.S. ... family members and first responders dealing with a heroin or narcotic painkiller overdose, the FDA said. Narcotic ...

  15. FDA Bans Sale of New R.J. Reynolds Cigarettes

    MedlinePLUS

    ... news/fullstory_154630.html FDA Bans Sale of New R.J. Reynolds Cigarettes Products didn't meet ... J. Reynolds Tobacco Co. to stop selling four new cigarette brands because they violate provisions of the ...

  16. NCI Director Also to Be Interim FDA Commissioner

    Cancer.gov

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

  17. FDA Approves New Drug for Schizophrenia, Bipolar Disorder

    MedlinePLUS

    ... fullstory_154708.html FDA Approves New Drug for Schizophrenia, Bipolar Disorder Vraylar is an atypical antipsychotic taken ... HealthDay News) -- A new antipsychotic drug to treat schizophrenia and bipolar disorder in adults has been approved ...

  18. 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, ...

  19. Sliding Motility in Mycobacteria

    PubMed Central

    Martínez, Asunción; Torello, Sandra; Kolter, Roberto

    1999-01-01

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

  20. Effect of the FDA on health care investments

    NASA Astrophysics Data System (ADS)

    Cleary, David J.

    1994-12-01

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

  1. "Adulterated" Androstenedione: What FDA's Action against Andro Means for Industry

    PubMed Central

    Collins, Richard D; Feldstein, Alan H

    2004-01-01

    On March 11, 2004, the Food and Drug Administration (FDA) pronounced that dietary supplement products containing androstenedione were adulterated new dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA issued a press release, held a news conference, and sent warning letters to 23 companies that had manufactured, marketed or distributed the products containing androstenedione. In its warning letters, FDA threatened possible enforcement actions for noncompliance. The authors have looked at the warning letters, statutes, regulations, and media reports to analyze the legal grounds and standards upon which FDA acted against androstenedione and question the appropriateness of the action taken. They have also looked at the negative impact that FDA's lack of communication and cooperation with Industry is having upon the fitness nutrition industry and the marketing of dietary supplements containing new dietary ingredients. The authors also suggest what might be done to ameliorate this escalating problem including more cooperation between FDA and Industry and more research into the benefits and use of supplement products.

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

    PubMed

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

    2015-02-01

    In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval. PMID:25603042

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

    PubMed

    Drum, Bruce

    2004-01-01

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

  4. Labeling of trans fatty acid content in food, regulations and limits-the FDA view.

    PubMed

    Moss, Julie

    2006-05-01

    With the scientific evidence associating trans fatty acid (TFA) intake with an increased risk of coronary heart disease (CHD), the U.S. Food and Drug Administration (FDA) issued a final rule that requires the declaration of the amount of TFA present in foods, including dietary supplements, on the nutrition label by January 1, 2006. The addition of TFA to the nutrition label will lead to the prevention of 600 to 1200 cases of CHD and 240-480 deaths each year saving Dollars 900 million to Dollars 1.8 billion per year in medical costs, lost productivity, and pain and suffering. For the purpose of nutrition labeling, TFA are defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration. There are many issues that FDA has yet to resolve: (1) defining nutrient content claims for "free" and "reduced" levels of trans fat, (2) placing limits on the amount of TFA in conjunction with saturated fat limits for nutrient content claims, health claims, and disclosure and disqualifying levels, (3) a daily value, and (4) a possible footnote or disclosure statement to enhance consumer understanding of cholesterol raising lipids. FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) requesting comments on the unresolved issues. FDA will also be conducting consumer research to determine consumer understanding of various TFA labeling possibilities. Comments to the ANPR, results of consumer research and current science will be used by FDA to resolve these issues and to determine future rulemaking for TFA labeling. PMID:16713387

  5. Slowing the Summer Slide

    ERIC Educational Resources Information Center

    Smith, Lorna

    2012-01-01

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

  6. Slowing the Summer Slide

    ERIC Educational Resources Information Center

    Smith, Lorna

    2012-01-01

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

  7. Lap-Dissolve Slides

    ERIC Educational Resources Information Center

    Fine, Leonard W.; And Others

    1977-01-01

    Discusses the use of lap-dissolve projection to give students pre-laboratory instruction on an upcoming experiment. In this technique, two slide projectors are operated alternately so that one visual image fades away while the next appears on the same screen area. (MLH)

  8. Black and White Slides.

    ERIC Educational Resources Information Center

    Tanner, Jackie

    1979-01-01

    Outlines procedures for using some photographic techniques to start a black and white slide collection. Instructions are given for: (1) necessary equipment and materials; (2) photographing images such as photos, charts or drawings; (3) developing the film; and (4) setting up the filing system. Photographs and drawings illustrate the process. (AMH)

  9. 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

  10. 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

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

    PubMed

    Hodel, D

    1995-06-01

    Legislative proposals to reform the mandate of the Food and Drug Administration (FDA) are underway in Washington. An ad hoc coalition has been formed by many leading AIDS groups to participate in the debate. The group is drafting principles for evaluating FDA reform proposals from the standpoint of people with life-threatening disease. Items under discussion for the reform include shifting more efficacy studies to a post-marketing setting. This would enable drugs to reach the market much faster; however, the risks are greater because more people will be taking the drugs with less data about hazards. Another measure would utilize local Institutional Review Boards (IRBs) to review proposals for the early human testing (phase I clinical trials) on drugs. In addition, a measure was proposed that would privatize certain drug safety reviews, by relegating them to independent testing or accrediting institutions. Another measure would permit the promotion of FDA-approved drugs for off-label uses. A measure to impose statutory time limits on FDA review is also under discussion. Finally, the possible removal of export barriers for non-FDA-approved drugs is under review. PMID:11362691

  12. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an...

  13. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

  14. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an...

  15. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... response to a request for input from FDA on this topic in March 2010 (75 FR 11893, March 12, 2010... HUMAN SERVICES Food and Drug Administration FDA Transparency Initiative: Improving Transparency to... Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative:...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

  17. 21 CFR 830.210 - Eligibility for use of FDA as an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Eligibility for use of FDA as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.210 Eligibility for use of FDA as an issuing agency. When FDA acts as an issuing agency, any labeler will...

  18. 21 CFR 830.220 - Termination of FDA service as an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.220 Termination of FDA service as an issuing agency. (a) FDA may end our services as an issuing agency if...

  19. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

  20. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

  1. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

  2. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

  4. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional...

  6. 21 CFR 830.100 - FDA accreditation of an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... issuing agency. (b) Accreditation criteria. FDA may accredit an organization as an issuing agency, if...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed...

  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

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

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

    PubMed

    Card, Melissa M

    2013-01-01

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

  11. Theory of sliding-mode triboelectric nanogenerators.

    PubMed

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

    2013-11-20

    The triboelectric nanogenerator (TENG) is a powerful approach toward new energy technology, especially for portable electronics. A theoretical model for the sliding-mode TENG is presented in this work. The finite element method was utilized to characterize the distributions of electric potential, electric field, and charges on the metal electrodes of the TENG. Based on the FEM calculation, the semi-analytical results from the interpolation method and the analytical V-Q-x relationship are built to study the sliding-mode TENG. The analytical V-Q-x equation is validated through comparison with the semi-analytical results. Furthermore, based on the analytical V-Q-x equation, dynamic output performance of sliding-mode TENG is calculated with arbitrary load resistance, and good agreement with experimental data is achieved. The theory presented here is a milestone work for in-depth understanding of the working mechanism of the sliding-mode TENG, and provides a theoretical basis for further enhancement of the sliding-mode TENG for both energy scavenging and self-powered sensor applications. PMID:24038597

  12. Railgun rail gouging by hypervelocity sliding contact

    SciTech Connect

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

    1988-01-01

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

  13. Railgun rail gouging by hypervelocity sliding contact

    SciTech Connect

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

    1989-01-01

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

  14. 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

  15. A tale of two transparency attempts at FDA.

    PubMed

    Tai, Laurence

    2013-01-01

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

  16. 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

  17. The Easy Way to Create Computer Slide Shows.

    ERIC Educational Resources Information Center

    Anderson, Mary Alice

    1995-01-01

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

  18. 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.

  19. 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.

  20. 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...

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

    ERIC Educational Resources Information Center

    Pryor, Harold George

    1986-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-02-01

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

  3. 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

  4. 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

  5. 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.

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

    PubMed

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

    1998-01-01

    "This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European conformity assessment procedures with the new 510(k) paradigm will appear in an upcoming issue of BI&T. PMID:9800008

  7. 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

  8. Static and dynamic friction in sliding colloidal monolayers

    PubMed Central

    Vanossi, Andrea; Manini, Nicola; Tosatti, Erio

    2012-01-01

    In a pioneer experiment, Bohlein et al. realized the controlled sliding of two-dimensional colloidal crystals over laser-generated periodic or quasi-periodic potentials. Here we present realistic simulations and arguments that besides reproducing the main experimentally observed features give a first theoretical demonstration of the potential impact of colloid sliding in nanotribology. The free motion of solitons and antisolitons in the sliding of hard incommensurate crystals is contrasted with the soliton–antisoliton pair nucleation at the large static friction threshold Fs when the two lattices are commensurate and pinned. The frictional work directly extracted from particles’ velocities can be analyzed as a function of classic tribological parameters, including speed, spacing, and amplitude of the periodic potential (representing, respectively, the mismatch of the sliding interface and the corrugation, or “load”). These and other features suggestive of further experiments and insights promote colloid sliding to a unique friction study instrument. PMID:23019582

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

    PubMed

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

    2016-01-01

    Virtual microscopy using digitized slides has become more widespread in teaching in recent years. There have been no direct comparisons of the use of virtual microscopy and the use of microscopes and glass slides. Third-year veterinary students from two different schools completed a simple objective test, covering aspects of histology and histopathology, before and after a practical class covering relevant material presented as either glass slides viewed with a microscope or as digital slides. There was an overall improvement in performance by students at both veterinary schools using both practical formats. Neither format was consistently better than the other, and neither school consistently outperformed the other. In a comparison of student appraisal of use of digital slides and microscopes, the digital technology was identified as having many advantages. PMID:26752020

  10. Detection of felt tip markers on microscope slides

    NASA Astrophysics Data System (ADS)

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

    2014-03-01

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

  11. 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.

  12. FDA fast-tracking of pet population control drugs.

    PubMed

    Weissinger, J; McRae, D

    1991-04-01

    Theriogenologists have been studying estrus prevention and termination of pregnancy in dogs for at least 2 decades. However, drugs approved for estrus suppression are few. No dog or cat abortifacients or male dog and cat sterilants have been approved. Marketed drugs with alternate indications that have antiestrus and antihormonal activity might be good candidates for study after obtaining an INAD from FDA. With the support of the original drug sponsor or manufacturer and appropriate safety and effectiveness studies, these products may be studied for additional label claims. New (not previously approved) drugs additionally need detailed information regarding the synthesis and manufacturing controls. Drugs offering substantial benefit over existing therapeutics may be eligible for expedited review. Prior to starting any studies in this area, clinical investigators and sponsors should communicate with FDA, an INAD must be granted, and the protocol submitted for evaluation. Approvability is evaluated after establishment of safety and effectiveness in clinical field trials. PMID:2045345

  13. Discrete sliding-mode control of a PWM inverter for sinusoidal output waveform synthesis with optimal sliding curve

    SciTech Connect

    Jung, S.L.; Tzou, Y.Y.

    1996-07-01

    This paper presents a discrete sliding-mode control scheme with feedforward compensation for the closed-loop regulation of the pulse-width modulated (PWM) inverter used in an uninterruptible power supply (UPS). The proposed feedforward controller can effectively improve the tracking performance of the PWM inverter. In designing the sliding-mode controller, the authors have taken load disturbance into consideration to enhance the robustness of the PWM inverter. Moreover, the upper bound of the load disturbance under which the sliding condition can be maintained has also been derived. The sliding curve of the sliding-mode controller is designed such that the behavior of the controlled PWM inverter is optimal subject to the selected cost function. Due to the coordinate transformation proposed in this paper, only the output voltage needs to be measured as feedback for the purpose of closed-loop regulation. Simulation and experimental results are given to show the effectiveness of the proposed control scheme.

  14. Current and future state of FDA-CMS parallel reviews.

    PubMed

    Messner, D A; Tunis, S R

    2012-03-01

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians. PMID:22343814

  15. 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

  16. Tissue slide-based microRNA characterization of tumors: how detailed could diagnosis become for cancer medicine?

    PubMed Central

    2014-01-01

    miRNAs are short, non-coding, regulatory RNAs that exert cell type-dependent, context-dependent, transcriptome-wide gene expression control under physiological and pathological conditions. Tissue slide-based assays provide qualitative (tumor compartment) and semi-quantitative (expression levels) information about altered miRNA expression at single-cell resolution in clinical tumor specimens. Reviewed here are key technological advances in the last 5 years that have led to implementation of fully automated, robust and reproducible tissue slide-based assays for in situ miRNA detection on US FDA-approved instruments; recent tissue slide-based discovery studies that suggest potential clinical applications of specific miRNAs in cancer medicine are highlighted; and the challenges in bringing tissue slide-based miRNA assays into the clinic are discussed, including clinical validation, biomarker performance, biomarker space and integration with other biomarkers. PMID:25090088

  17. Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA.

    PubMed

    Fuller, Janie; Ashar, Binita S; Carey-Corrado, Julia

    2005-01-01

    Laparoscopic trocars, medical devices used to gain access into the abdominal cavity, are the most common device named in malpractice injury claims associated with laparoscopic procedures. As part of its ongoing adverse event reporting program, the U.S. Food and Drug Administration (FDA) requires manufacturers and user facilities to file a report whenever a device was or may have been a factor in a death or serious injury. The FDA collects data from these reports in its Manufacturer and User Facility Device Experience (MAUDE) database. This study presents an analysis of fatality and injury data on laparoscopic trocars found in MAUDE reports received from January 1, 1997, through June 30, 2002, including 31 fatal injury cases and 1353 reports on nonfatal injuries. Cholecystectomy was the procedure most frequently associated with both fatal and nonfatal trocar injuries. Most fatalities involved vascular injuries. All fatality reports that identified the trocar design involved either a shielded trocar (which has a retractable shield that covers the trocar blade before and after insertion to help protect abdominal and pelvic organs from inadvertent puncture) or an optical trocar (which allows laparoscopists to view the cutting tip as it penetrates the tissues). Narrative comments cited surgical technique, device problems, and patient characteristics as contributing factors. Among nonfatal injuries, a change in surgical management such as additional surgical procedure--primarily laparotomy--prolonged surgery, or aborted surgery was reported most frequently for vascular and hollow viscus injuries. Many reports did not identify the device model, surgical procedure, or event timing, limiting Food and Drug Administration (FDA) and manufacturer investigations into whether the device contributed to the event. The most common manufacturer conclusions indicated the trocar was not returned, and no conclusions could be drawn about the trocar's contribution to the event. Fatalities occur with procedures in which shielded trocars and optical trocars are used. Further study is needed to evaluate the high proportion of reports associated with laparoscopic cholecystectomy. Laparoscopists should retain for evaluation any devices implicated in patient injuries and should ensure that detailed information on adverse events is provided in adverse event reports to the FDA. The FDA's Manufacturer and User Facility Device Experience (MAUDE) database can be a valuable source for information on adverse outcomes associated with medical devices and, given an understanding of its limitation, provides researchers with a viable adjunct to published literature and litigation surveys for obtaining this information. PMID:16036187

  18. FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

    MedlinePLUS

    ... Related Consumer Updates Indoor Tanning: The Risks of Ultraviolet Rays Five Tips for a Safer Spring Break More ... Downloading Viewers and Players . FDA Accessibility Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website ...

  19. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... to any committee of an independent scientific or technical organization which is working under...

  20. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... to any committee of an independent scientific or technical organization which is working under...

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

    MedlinePLUS

    ... Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share ... deficiency. Posted 03/22/2016 More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) ...

  2. FDA Orders 'Black Box' Warning Label on Essure Long-Acting Contraceptive

    MedlinePLUS

    ... nlm.nih.gov/medlineplus/news/fullstory_157520.html FDA Orders 'Black Box' Warning Label on Essure Long- ... U.S. Food and Drug Administration announced Monday. The FDA also ordered Essure's manufacturer, Bayer, to conduct a ...

  3. 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

    ... HUMAN 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... announcing the availability of a draft guidance entitled ``Guidance for Clinical Investigators, Industry,...

  4. Frequency shaped sliding mode synthesis

    SciTech Connect

    Young, K.D. ); Oezguener, U. . Dept. of Electrical Engineering)

    1990-03-01

    A sliding mode design method based on frequency shaped quadratic optimal control formulation is proposed in this paper. This method is applied to the design of a VSC controller for a flexible link robot arm. Simulation results show that the excitation of the link deformations can be minimized by introducing frequency-shaping in the synthesis of sliding mode. 7 refs., 19 figs.

  5. Using Scrap Slides for Art.

    ERIC Educational Resources Information Center

    Hanlon, Heather

    1979-01-01

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

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

    PubMed

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

    2016-03-01

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

  7. 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

  8. Introducing Slide Sets for the Introductory Astronomy Instructor

    NASA Astrophysics Data System (ADS)

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

    2014-11-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1... General 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 of food that is found during an...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false FDA recognition of exclusive marketing rights. 516... SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

  12. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What criteria does FDA use to order a detention? 1... General 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 of food that is found during an...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

  15. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to...

  16. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false When must prior notice be submitted to FDA? 1.279... Imported Food § 1.279 When must prior notice be submitted to FDA? (a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  17. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false When must prior notice be submitted to FDA? 1.279... Imported Food § 1.279 When must prior notice be submitted to FDA? (a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What records must be made available to FDA? 111... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

  19. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices....

  20. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Commercially... Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled... other FDA-regulated products. Thus, the manufacturer of an IUO IVD product is not necessarily...

  2. 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... SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

  3. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to...

  4. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

  5. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant...

  6. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What criteria does FDA use to order a detention? 1... General 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 of food that is found during an...

  7. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Will FDA assign me a registration number? 1271.27..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

  9. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the...

  10. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to...

  11. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

  12. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices....

  13. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When must prior notice be submitted to FDA? 1.279... Imported Food § 1.279 When must prior notice be submitted to FDA? (a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  14. 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....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices....

  15. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  16. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What criteria does FDA use to order a detention? 1... General 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 of food that is found during an...

  17. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Will FDA assign me a registration number? 1271.27..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

  18. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false FDA recognition of exclusive marketing rights. 516... SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

  20. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to...

  1. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false When must prior notice be submitted to FDA? 1.279... Imported Food § 1.279 When must prior notice be submitted to FDA? (a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  2. 21 CFR 830.120 - Responsibilities of an FDA-accredited issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Responsibilities of an FDA-accredited issuing... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.120 Responsibilities of an FDA-accredited issuing agency. To maintain its accreditation,...

  3. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices....

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Formal Meetings Between FDA... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and...

  5. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false FDA, other Federal, and State requirements. 35.7 Section....7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices....

  6. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false FDA recognition of exclusive marketing rights. 516... SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive marketing rights. (a) FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable)...

  7. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

  8. 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..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

  10. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What records must be made available to FDA? 111... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

  11. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the... reporting requirements on FDA recalls. DATES: Submit either electronic or written comments on the...

  12. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Will FDA assign me a registration number? 1271.27..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

  13. 21 CFR 801.57 - Discontinuation of legacy FDA identification numbers assigned to devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Discontinuation of legacy FDA identification... Device Identification § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices... been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use...

  14. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false When must prior notice be submitted to FDA? 1.279... Imported Food § 1.279 When must prior notice be submitted to FDA? (a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What records must be made available to FDA? 111... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What records must be made available to FDA? 111... records must be made available to FDA? (a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA...

  17. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How will FDA handle classified information in an... Animal Consumption What Is the Appeal Process for A Detention Order? § 1.406 How will FDA handle... disclosure in the interest of national security (“classified information”), FDA will not provide you...

  18. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on a premarket notification. 807.100... IMPORTERS OF DEVICES Premarket Notification Procedures § 807.100 FDA action on a premarket notification. (a) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to...

  19. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant...

  20. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false When does FDA have to issue a decision on an... Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a decision... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Will FDA assign me a registration number? 1271.27..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What criteria does FDA use to order a detention? 1... General 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 of food that is found during an...

  4. No sliding in time

    NASA Astrophysics Data System (ADS)

    Shtengel, Kirill; Nayak, Chetan; Bishara, Waheb; Chamon, Claudio

    2006-03-01

    We analyse the following apparent paradox: As has been recently proved by Hastings, under a general set of conditions, if a local Hamiltonian has a spectral gap above its (unique) ground state, all connected equal-time correlation functions of local operators decay exponentially with distance. On the other hand, statistical mechanics provides us with examples of 3D models displaying so-called sliding phases which are characterised by the algebraic decay of correlations within 2D layers and exponential decay in the third direction. Interpreting this third direction as time would imply a gap in the corresponding (2+1)D quantum Hamiltonian which would seemingly contradict Hastings' theorem. The resolution of this paradox lies in the non-locality of such a quantum Hamiltonian.

  5. T-Slide Linear Actuators

    NASA Technical Reports Server (NTRS)

    Vranish, John

    2009-01-01

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

  6. 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.

  7. Sliding temperatures of ice skates

    NASA Astrophysics Data System (ADS)

    Colbeck, S. C.; Najarian, L.; Smith, H. B.

    1997-06-01

    The two theories developed to explain the low friction of ice, pressure melting and frictional heating, require opposite temperature shifts at the ice-skate interface. The arguments against pressure melting are strong, but only theoretical. A set of direct temperature measurements shows that frictional heating is the dominant mechanism because temperature behaves in the manner predicted by the theory of frictional heating. Like snow skis, ice skates are warmed by sliding and then cool when the sliding stops. The temperature increases with speed and with thermal insulation. The sliding leaves a warm track on the ice surface behind the skate and the skate sprays warm ejecta.

  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. Creative penmanship in animal testing prompts FDA controls.

    PubMed

    Smith, R J

    1977-12-23

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

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

    NASA Astrophysics Data System (ADS)

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

    2003-06-01

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

  12. An overview of FDA-approved biologics medicines.

    PubMed

    Kinch, Michael S

    2015-04-01

    Recombinant DNA technologies revolutionized medicine. Herein, the approvals and mechanistic basis of biologics-based medicines are analyzed. The overall and relative rate of FDA approvals for recombinant proteins grew from the 1980s through the first half-decade of the new millennium. Over time, the number of biologics gaining approval for an orphan indication has climbed to more than 50% in the current decade. The field has been dynamic in terms of the types of biologics, indications targeted and the mechanistic basis of drug activity. Despite impressive increases in recombinant-protein-based medicine, the rate of new biologics approvals could have leveled out. PMID:25220442

  13. 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.

  14. Vesicocutaneous fistula after sliding hernia repair

    PubMed Central

    Mittal, Varun; Kapoor, Rakesh; Sureka, Sanjoy

    2016-01-01

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

  15. 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.

  16. 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.

  17. 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

  18. Sliding regimes on slow manifolds of systems with fast actuators

    NASA Technical Reports Server (NTRS)

    Sira-Ramirez, Hebertt; Dwyer, Thomas A. W., III

    1987-01-01

    In this article the slow manifold of a system with actuator parasitics is used as a sliding surface on which a Variable Structure Controller recovers the qualitative properties of the reduced order, closed loop system obtained from an ideal actuator-based feedback controller design. Illustrative examples are presented, where (1) the simplicity of reduced order singular perturbation design methods; and (2) the robustness of Variable Structure sliding modes, are advantageously combined.

  19. 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.

  20. 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.

  1. 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

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

    PubMed

    Yuan, Shu

    2015-01-01

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

  3. Rough viscoelastic sliding contact: theory and experiments.

    PubMed

    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)] 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)]. 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. PMID:24730853

  4. 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.

  5. The FDA may not regulate tobacco products as "drugs" or as "medical devices".

    PubMed

    Merrill, R A

    1998-04-01

    Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products. The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority. This inference is particularly inappropriate in the case of tobacco regulation, he maintains, because there is compelling evidence that Congress had no intention of delegating this authority to the FDA. He is unpersuaded that presidential approval legally sanctions the FDA's claim of authority by granting it a superficial political legitimacy. Finally, he reminds us of the FDA's own repeated denials of jurisdiction over tobacco products, and he recalls the numerous times that Congress passed legislation directed at tobacco without granting the FDA any role in its regulation. Professor Merrill's Essay, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit. PMID:10557545

  6. 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.

  7. The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing.

    PubMed

    Evans, Barbara J

    2015-01-01

    The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency's Part 812 investigational device exemption (IDE) regulation. Genome sequencing--for reasons explained in this article--blurs the line between categories of in vitro diagnostic (IVD) research that FDA traditionally has regulated and categories of research that FDA traditionally has not regulated. This blurring creates a risk that FDA may overstep its proper authority to regulate fundamental genomic and medical research. This article surveys the legal limits of FDA's authority'to subject genomic research to its IDE requirements. Section 1 explains that FDA has authority to regulate clinical investigations of devices, but is not authorized to regulate investigations that merely use devices to expand medical knowledge or to conduct fundamental research, unless special circumstances apply. Section 2 discusses the special circumstances that can expand or limit FDA's authority to regulate a specific clinical investigation, and Section 3 demonstrates these using an example. Section 4 explores concerns that arose in recent years about risks to human subjects in a certain type of investigation known as sponsor-investigator studies. In response to these concerns, FDA has suggested that it can regulate such studies in ways that threaten to expand FDA's regulation of research at academic medical centers beyond its proper scope. These concerns, while valid in some academic research contexts, seem inapposite in the setting of genomic research programs funded by responsible.entities such as the National Institutes of Health (NIH). Moreover, FDA's regulations do not. appear to support the proposition that FDA can regulate sponsor-investigator studies more expansively than it regulates other studies. Section 5 explores specific ways that NIH, clinical investigators, and FDA might work together to rationalize FDA's regulation of NIH-funded-genomic research. PMID:26302600

  8. 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

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within...

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  10. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within...

  11. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within...

  12. 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

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

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  14. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within...

  15. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  16. 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

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within...

  17. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  18. Constraining the characteristics of tsunami waves from deformable submarine slides

    NASA Astrophysics Data System (ADS)

    Weiss, R.; Krastel, S.; Anasetti, A.; Wuennemann, K.

    2012-12-01

    As a marine hazard, submarine slope failures have the potential to directly destroy offshore infrastructure, and, if a tsunami is generated, it also endangers the life of those who live and work at the coastline. The hazard and risk from tsunamis generated by submarine mass failure is difficult to quantify and evaluate due to difficulties to estimate the time of trigger for submarine slide bodies, and the problems to constrain the characteristics of the triggered submarine landslide. The missing age constraint and the unconstrained tsunami-wave characteristics generate unquantifiable uncertainties in hazard assessments. To lower the uncertainty from the unconstrained tsunami-characteristic, we present a method that determines material parameters for the slide body to constrain the generated tsunami waves with an iterative method. Our method employs the mapped distribution of landslide run-out masses and their comparison with simulations. It assumes that the slide material can be approximated by bulk values during the slide motion. The free parameter that will be changed during in iterations is the viscosity of the slide body. The goal of the procedure is to find the optimal viscosity, which represents the viscosity for which the slide body matches well with the mapped slide run-out masses. The tsunami waves generated in the simulations employing the optimal viscosity are then considered constrained within the framework of our work. While we understand that viscosity does not accurately describe the dynamics of the slide body, we argue that viscosity can be employed as a first-order approximation to constrain the tsunami wave characteristics. To demonstrate our method, we make use of Valdes slide run-out masses off the Chilean coast. We show the difference in tsunami characteristics for slides whose viscosity is too low, too high and optimal. Furthermore, we will present an overview on how these differences result in dramatically different wave amplitudes as functions of the distance to the landslide-trigger area in general and for the Chilean coast due to the Valdes slide.

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

    PubMed

    Janiga, Gábor

    2014-04-01

    This work investigates the flow in a benchmark nozzle model of an idealized medical device proposed by the FDA using computational fluid dynamics (CFD). It was in particular shown that a proper modeling of the transitional flow features is particularly challenging, leading to large discrepancies and inaccurate predictions from the different research groups using Reynolds-averaged Navier-Stokes (RANS) modeling. In spite of the relatively simple, axisymmetric computational geometry, the resulting turbulent flow is fairly complex and non-axisymmetric, in particular due to the sudden expansion. The resulting flow cannot be well predicted with simple modeling approaches. Due to the varying diameters and flow velocities encountered in the nozzle, different typical flow regions and regimes can be distinguished, from laminar to transitional and to weakly turbulent. The purpose of the present work is to re-examine the FDA-CFD benchmark nozzle model at a Reynolds number of 6500 using large eddy simulation (LES). The LES results are compared with published experimental data obtained by Particle Image Velocimetry (PIV) and an excellent agreement can be observed considering the temporally averaged flow velocities. Different flow regimes are characterized by computing the temporal energy spectra at different locations along the main axis. PMID:24561349

  20. Toward an implantable wireless cardiac monitoring platform integrated with an FDA-approved cardiovascular stent.

    PubMed

    Chow, Eric Y; Beier, Brooke L; Francino, Antonio; Chappell, William J; Irazoqui, Pedro P

    2009-10-01

    Continuous monitoring of blood pressure from a minimally invasive device in the pulmonary artery can serve as a diagnostic and early warning system for cardiac health. The foremost challenge in such a device is the wireless transfer of data and power from within the blood vessel to an external device while maintaining unrestricted flow through the artery. We present a miniaturized system, which is attached to the outer surface of a regular or drug-eluting FDA-approved stent. When expanded, the stent maintains a patent vessel lumen while allowing contact between the electronic sensors and the blood supply. The stent-based antenna can be used for both wireless telemetry and power transfer for the implanted electronics. Using the stent platform as both a radiating antenna and a structural support allows us to take advantage of an FDA-approved device whose safety and surgical procedure are well established. The electronics package has been reduced to an area of less than 1 mm(2), with a thickness under 300 mum. A minimally invasive implantation procedure allows the delivery of the stent-based implant in nearly any major vessel of the body. This article describes an initial prototype with two stents configured as a single dipole, a 2.4-GHz transmitter microchip, and a battery, and validates transcutaneous transmission through ex vivo and in vivo porcine studies. The results demonstrate the feasibility of a stent-based wireless platform for continuous monitoring of blood pressure. PMID:19807844

  1. 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

  2. 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

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

    PubMed

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

    2013-12-01

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

  4. 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

  5. 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

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

    PubMed Central

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

    2016-01-01

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

  7. 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

  8. Registration of organs with sliding interfaces and changing topologies

    NASA Astrophysics Data System (ADS)

    Berendsen, Floris F.; Kotte, Alexis N. T. J.; Viergever, Max A.; Pluim, Josien P. W.

    2014-03-01

    Smoothness and continuity assumptions on the deformation field in deformable image registration do not hold for applications where the imaged objects have sliding interfaces. Recent extensions to deformable image registration that accommodate for sliding motion of organs are limited to sliding motion along approximately planar surfaces or cannot model sliding that changes the topological configuration in case of multiple organs. We propose a new extension to free-form image registration that is not limited in this way. Our method uses a transformation model that consists of uniform B-spline transformations for each organ region separately, which is based on segmentation of one image. Since this model can create overlapping regions or gaps between regions, we introduce a penalty term that minimizes this undesired effect. The penalty term acts on the surfaces of the organ regions and is optimized simultaneously with the image similarity. To evaluate our method registrations were performed on publicly available inhale-exhale CT scans for which performances of other methods are known. Target registration errors are computed on dense landmark sets that are available with these datasets. On these data our method outperforms the other methods in terms of target registration error and, where applicable, also in terms of overlap and gap volumes. The approximation of the other methods of sliding motion along planar surfaces is reasonably well suited for the motion present in the lung data. The ability of our method to handle sliding along curved boundaries and for changing region topology configurations was demonstrated on synthetic images.

  9. Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

    PubMed Central

    Holbein, M. E. Blair

    2015-01-01

    Clinical investigators invoke a number of specific regulatory requirements if their study includes use of a pharmaceutical agent. Studies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA. If a study meets specific regulatory exemption criteria, then an IND may not be needed. Individual investigators may meet the FDA definition of a sponsor-investigator, in which case the application process is generally less complicated than for commercial sponsors, and this review addresses only this circumstance. Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674). If the IND is approved, the study may begin 30 days after the FDA acknowledges receipt and assigns an IND. If the FDA requires additional information or if the study is placed on a “clinical hold,” the study must not proceed. While the IND is active, the investigator must also continue to meet a set of regulations for monitoring the study and reporting to the FDA. PMID:19602987

  10. Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation.

    PubMed

    1997-12-19

    The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate. PMID:10179303

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

    PubMed

    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

  12. 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

  13. 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

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

    ERIC Educational Resources Information Center

    Bodner, George M.; And Others

    1980-01-01

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

  15. 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

  16. Stop the Summer Reading Slide

    ERIC Educational Resources Information Center

    Lundstrom, Meg

    2005-01-01

    When teachers wave goodbye to their students as they head off for summer vacation, they might just be bidding farewell to some of their hard-won gains in reading skills. The "summer slide" is well-documented by research: Unless students read regularly during the break, they fall behind about three months in their reading achievement. This article…

  17. 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…

  18. Linear Motor With Air Slide

    NASA Technical Reports Server (NTRS)

    Johnson, Bruce G.; Gerver, Michael J.; Hawkey, Timothy J.; Fenn, Ralph C.

    1993-01-01

    Improved linear actuator comprises air slide and linear electric motor. Unit exhibits low friction, low backlash, and more nearly even acceleration. Used in machinery in which positions, velocities, and accelerations must be carefully controlled and/or vibrations must be suppressed.

  19. 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 (...

  20. 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)

  1. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  2. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action...

  3. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action...

  4. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action...

  5. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  6. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action...

  7. 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…

  8. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Examples of Graphic Enhancements Used by FDA A Appendix A to Part 201 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Used by FDA I. Section 201.66 Standard Labeling Format A. Overall 1. The “Drug Facts” labeling is...

  9. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... on this topic in March 2010 (75 FR 11893, March 12, 2010) and draft proposals from this phase are... HUMAN SERVICES Food and Drug Administration FDA Transparency Initiative: Draft Proposals for Public... of the second phase of the Transparency Initiative, the Food and Drug Administration (FDA)...

  10. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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  11. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action...

  12. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  13. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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... Used by FDA I. Section 201.66 Standard Labeling Format A. Overall 1. The “Drug Facts” labeling is...

  14. 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... Used by FDA I. Section 201.66 Standard Labeling Format A. Overall 1. The “Drug Facts” labeling is...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  16. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 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... Used by FDA I. Section 201.66 Standard Labeling Format A. Overall 1. The “Drug Facts” labeling is...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

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

    PubMed

    Welle, Cristin; Krauthamer, Victor

    2012-03-01

    The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4]. PMID:22481744

  19. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

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

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

    MedlinePLUS

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

  1. 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...

  2. 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,…

  3. 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,…

  4. 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…

  5. 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.

  6. FDA regulation of clinical high intensity focused ultrasound (HIFU) devices.

    PubMed

    Harris, Gerald R

    2009-01-01

    In the U. S., medical devices are regulated under the authority of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, with the Food and Drug Administration's Center for Devices and Radiological Health having primary responsibility. The Act defines several regulatory paths to market depending on the complexity of the device and indications for use. For most high intensity focused ultrasound (HIFU) devices the premarket submissions include both pre-clinical and clinical data. Pre-clinical testing generally comprises ultrasound power measurements and field characterization, in vitro and in vivo temperature measurements, thermal computational modeling, and demonstrating the accuracy for targeting the region of interest and monitoring treatment progress. Protocols for clinical trials are developed by the device sponsor in conjunction with FDA medical and scientific staff. Currently there are no recognized guidance or standards documents for HIFU testing that could be used in the regulatory review process, but such work is underway within the International Electrotechnical Commission. PMID:19963452

  7. 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

  8. Asymmetric kinematic changes in speaking rate explored with FDA

    NASA Astrophysics Data System (ADS)

    Lee, Sungbok; Narayanan, Shrikanth; Byrd, Dani

    2003-10-01

    We report preliminary results for the effect on tongue movements of varying speaking rate. Speech acoustics and tongue tip and body kinematic data were collected using electromagnetic articulography (EMA) [Perkell et al., J. Acoust. Soc. Am. 92 (1992)]. A subject read each one of 20 sentences three times in a row with a predefined order of combination of three speaking rates (normal, medium, fast). Velocity and acceleration were derived using functional data analysis (FDA) [Ramsay et al., J. Acoust. Soc. Am. 99 (1996)] for smoother estimation of acceleration from the displacement data. Global utterance analyses of phase-space and variability in the displacement-velocity and the velocity-acceleration relations indicate that the fast speech exhibits comparable tongue tip displacements to normal speech but significantly larger accelerations (p<0.00). The difference in the order of combination of speaking rates (e.g., normal changing to fast versus fast to normal) shows significant effects on both voicing effort (expressed as rms energy) and the kinematic parameters. Finally, kinematic variability at some points in the utterance is much more constrained than at other points, irrespective of speaking rate. A possible interpretation of this is that particular portions of the utterance require this stability for linguistic or articulatory reasons. [Work supported by NIH.

  9. 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

  10. 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.

  11. FDA review divisions: performance levels and the impact on drug sponsors.

    PubMed

    Milne, C-P; Kaitin, K I

    2012-03-01

    Sponsors of new drug applications (NDAs) confront a host of uncertainties, one of the more vexing of which is negotiating the differing and inconsistent policies and standards among the various US Food and Drug Administration (FDA) drug review divisions. The FDA faces many challenges as well, internal and external, that confound its efforts to provide a consistent and timely review process. In this article, we examine various input factors, such as the number of regulatory filings, that contribute to fluctuations in the annual FDA workload, as well as output factors, such as NDA approval times, that are often viewed by sponsors as measures of the FDA's performance. Interdivisional differences at the FDA, in both input and output factors as well as other process-related factors, such as issuance of complete response letters, division staff levels, and quality of the sponsor's application, are considered in light of their contribution to the vagaries of the sponsors' experiences with the regulatory process. PMID:22336592

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

    NASA Astrophysics Data System (ADS)

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

    2016-02-01

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

  13. 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.

  14. Optimal sliding guidance algorithm for Mars powered descent phase

    NASA Astrophysics Data System (ADS)

    Wibben, Daniel R.; Furfaro, Roberto

    2016-02-01

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

  15. Automated single-slide staining device

    NASA Technical Reports Server (NTRS)

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

    1977-01-01

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

  16. 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)

  17. Preemption of the "fraud on the FDA" exception to Michigan's tort immunity statute for drug manufacturers: reconsidering Garcia and Desiano after Levine.

    PubMed

    Murdey, Jason

    2011-01-01

    In Buckman v. Plaintiff's Legal Committee, the Supreme Court of the United States held that "fraud on FDA" claims in medical device products liability actions were impliedly preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA). A Michigan statute that provides a complete regulatory compliance defense for drug manufacturers, absent a finding that the manufacturer defrauded or bribed the FDA. The Sixth Circuit found that the statute's fraud exception was preempted under Buckman, extending Buckman's holding to traditional products liability claims with circumstances involving fraud on the FDA. The Second Circuit reached the opposite conclusion in interpreting the same statute, confining Buckman to its narrow holding, preempting stand-alone fraud on the FDA claims while carving out a space for traditional state tort claims. The Supreme Court left the issue unresolved in its review of the Second Circuit, splitting 4-4. Since then, the great majority of courts have followed the Sixth Circuit's holding. This situation has created serious questions about the ability of Michigan citizens to obtain any relief in an action against a drug manufacturer. The Supreme Court recently refused to find blanket implied preemption for failure-to-warn claims involving prescription drugs in Wyeth v. Levine, holding that "common-law claims do not stand as an obstacle to the accomplishment of Congress's purposes in the FDCA." This holding casts serious doubt on the continued vitality of implied preemption in drug and device litigation, and could, and should, lead to a reexamination of the application of Buckman to traditional products liability claims against drug manufacturers from Michigan plaintiffs in circumstances that involve, inter alia, fraud on the FDA. The next time this application is considered, the court should allow plaintiffs to present evidence tending to show fraud on the FDA in rebutting the manufacturer's presumptive immunity under the Michigan immunity statute. PMID:24505848

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

    PubMed

    Lowes, Steve; Ackermann, Bradley L

    2016-02-01

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

  19. Rare cancer trial design: lessons from FDA approvals.

    PubMed

    Gaddipati, Himabindu; Liu, Ke; Pariser, Anne; Pazdur, Richard

    2012-10-01

    A systematic analysis of clinical trials supporting rare cancer drug approvals may identify concepts and terms that can inform the effective design of prospective clinical trials for rare cancers. In this article, using annual incidence ?6 of 100,000 individuals to define "rare cancer," we identified clinical trials for rare cancers, supporting U.S. Food and Drug Administration (FDA) drug approvals for rare cancer indications between December 1987 and May 2011. We characterized each selected trial for study design, sample size, primary efficacy endpoints, and statistical comparisons. We also profiled trials with regard to type of submission, review designation, and approval type. Our results indicated that, of 99 trials that supported the approvals of 45 drugs for 68 rare cancer indications, one third of these trials were randomized; 69% of approvals relied on objective response rate as the primary efficacy endpoint; and 63% were based on a single trial. Drugs granted accelerated approval appeared more likely to be associated with postmarketing safety findings, relative to drugs approved under the regular approval. Data collected across clinical trials were robust: Use of different lower incidence rates in analyzing these trials did not have effects on trial characteristics. The absolute number of drug approvals for rare cancer indications increased markedly over time. We concluded that one third of clinical trials supporting drug approvals for rare cancer indications were randomized, affirming the feasibility and value of randomized trial design to evaluate drugs for rare cancers. Postmarketing safety data may relate to trial design and approval type. An operational definition of "rare cancer" can be useful for the analysis of trial data and for the path toward harmonizing the terminology in the area of clinical research on rare cancers. PMID:22718862

  20. Wide-field lensfree imaging of tissue slides

    NASA Astrophysics Data System (ADS)

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

    2015-07-01

    We developed a new imaging tool that can help pathologists in recording wide-field images of tissue slides. We present a simple cost-effective lens-free imaging method to record 2-4?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.

  1. Sliding osteotomies in mandibular reconstruction.

    PubMed

    Verdaguer, J; Soler, F; Fernandez-Alba, J; Concejo, C; Acero, J

    2001-04-15

    The aim of this article is to describe a few simple and atraumatic methods for mandibular reconstruction following the ablation of tumors or traumas. These reconstruction techniques are indicated for rebuilding short mandibular defects (less than 4 cm) or for patients in poor general condition with larger defects that cannot be remedied using longer and more complicated procedures. Five types of osteotomies were used: "C," single, double, bilateral sliding, and sagittal sliding. Osteotomies were performed on 14 patients, 13 with malignant tumors and one with a gunshot wound. Good results were obtained in 10 patients, total failure occurred in two, and complications without failure of the reconstruction arose in the other two. PMID:11373549

  2. 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…

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

    ERIC Educational Resources Information Center

    Reiser, Frank

    2012-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2012-10-01

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

  5. Designing Slide/Tape Self-Instruction; A Focus and Design Session.

    ERIC Educational Resources Information Center

    Makela, Lee A.

    A historian who has developed autoinstructional tape/slide lectures in East Asian history survey courses describes the steps he has found essential in production, introduces some available production and equipment resources, and points out means to enhance the effectiveness of presentations. Descriptions of his slides and accompanying commentary…

  6. 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...

  7. 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.

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

    PubMed Central

    2014-01-01

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

  9. 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…

  10. 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.

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

    PubMed

    Gaddis, Christine A

    2014-01-01

    A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protection afforded to drug manufacturers in product liability actions if plaintiffs can provide evidence that the drug manufacturer made misrepresentations to the FDA during the process of obtaining marketing approval for the drug. Currently, the federal circuits are in disagreement over whether these state "fraud-on-the-FDA" statutes should be federally preempted. This issue warrants resolution for drug manufacturers, private citizens, and state legislatures. This Comment will discuss the history and role of the FDA's authority in drug and medical device regulation; federal preemption generally and the Supreme Court's decisions that considered whether state law failure to warn claims are federally preempted in the context of drugs and medical devices; the Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, where the Court held that claims that a medical device manufacturer made fraudulent representations to the FDA were federally preempted because such claims interfered with the relationship between the FDA and the entities it regulated, state fraud-on-the-FDA statutory provisions, and the existing circuit split regarding whether those statutes should be federally preempted; the potential resolutions to the circuit split; and will conclude and advocate that the Supreme Court's Buckman holding be applied to federally preempt state fraud-on-the-FDA statutes because such statutes involve the relationship between a federal agency and the entity it regulates and thus undermine the FDA's authority. PMID:24772688

  12. 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.

  13. 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

  14. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... (76 FR 45820), FDA published a notice establishing fee rates for FY 2012 for domestic and foreign... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  15. 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

    ... for Industry and FDA,'' dated July 2001. In the Federal Register of December 28, 2011 (76 FR 81511...; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance...

  16. 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

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including...

  17. 76 FR 53912 - FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... HUMAN SERVICES Food and Drug Administration FDA's Public Database of Products With Orphan-Drug... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), Office of Orphan Products... mandates that FDA provide notice to the public respecting the designation of a drug as an orphan-drug....

  18. 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

    ... 21 Food and Drugs 3 2013-04-01 2013-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including...

  19. 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

    ... 21 Food and Drugs 3 2012-04-01 2012-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including...

  20. 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

    ... 21 Food and Drugs 3 2011-04-01 2011-04-01 false The Food and Drug Administration's (FDA's... and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including...

  1. 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

    ... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... data or other information available to FDA, including data not submitted by the manufacturer...

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance.... This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight...

  3. Is the lag screw sliding effective in the intramedullary nailing in A1 and A2 AO-OTA intertrochanteric fractures? A prospective study of Sliding and None-sliding lag screw in Gamma-III nail

    PubMed Central

    2012-01-01

    Object To compare the Sliding with Non-sliding lag screw of a gamma nail in the treatment of A1 and A2 AO-OTA intertrochanteric fractures. Materials and methods 80 patients were prospectively collected. In each group, AO/OTA 31-A were classified into group A. AO/OTA 31-A2.1 was classified as group B. We classified the A2.2 and A2.3 as group C. According to the set-screw locking formation of Gamma-III, the cases were randomly allocated to Sliding subgroup and Non-sliding subgroup in A, B and C groups. Follow-ups were performed 1, 3, 6 and 12 months postoperatively. Results In the Sliding group, the bone healing rate 3, 6, 12 months postoperatively reached 85.00%, 97.50%, 100% in group A, B and C. Meanwhile, in Non-sliding group, postoperatively, bone healing rate were 90.00%, 95.00% and 97.50% in group A, B and C, respectively. Both differences were not significant. Lower limb discrepancy between Sliding and Non-sliding pattern was significantly different in group C which represent fracture types of AO/OTA 31-A2.2 and A2.3 (0.573 ± 0.019 mm in Non-sliding group, 0.955 mm ± 0.024 mm in Sliding group, P < 0.001 ). Difference of sliding distance among the three groups was significant among group A, B and C: 0.48 mm ± 0.04 mm, 0.62 mm ± 0.07 mm and 0.92 mm ± 0.04 mm (P < 0.001). Differences in average healing time and Harris scores also presented no significance in the three groups. Conclusions As a result, we can conclude that the sliding distance is minimal in Gamma nails and it is related to the comminuted extent of the intertrochanteric area in A1 and A2 AO-OTA intertrochanteric fractures. For treating these kinds of fractures, the sliding of the lag screw of an Gamma nail does not improve any clinical results and in certain cases, such as highly comminuted A1 and A2 fractures, can therefore even benefit from a locked lag screw by tightening the set-screw. PMID:22938031

  4. 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...

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

    MedlinePLUS

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

  7. Blood donation, deferral, and discrimination: FDA donor deferral policy for men who have sex with men.

    PubMed

    Galarneau, Charlene

    2010-02-01

    U.S. Food and Drug Administration (FDA) policy prohibits blood donation from men who have had sex with men (MSM) even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different approach to analyzing discrimination claims. I draw on an institutional understanding of injustice to discern and describe five features of the MSM policy and its FDA context that contribute to its discriminatory effect. I note significant similarities in the 1980s policy of deferring Haitians, suggesting an historical pattern of discrimination in FDA deferral policy. Finally, I point to changes needed to move toward a nondiscriminatory deferral policy. PMID:20131170

  8. FDA Approves First Flu Shot with Added Ingredient to Boost Immune Response

    MedlinePLUS

    ... medlineplus/news/fullstory_155913.html FDA Approves First Flu Shot With Added Ingredient to Boost Immune Response ... WEDNESDAY, Nov. 25, 2015 (HealthDay News) -- The first flu vaccine with an adjuvant has been approved for ...

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

    PubMed

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

    2016-03-01

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

  11. 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

  12. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How does FDA define key terms and phrases in this subpart? 4.2 Section 4.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Combination Products § 4.2 How does FDA define key terms and phrases in this subpart? The terms listed in...

  13. 21 CFR 4.2 - How does FDA define key terms and phrases in this subpart?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2009-01-01

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

  16. 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

  17. 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)

  18. Rate Dependence of AE Activity during Frictional Sliding

    NASA Astrophysics Data System (ADS)

    Yabe, Y.

    2001-12-01

    In previous studies, acoustic emission (AE) events have been observed during frictional sliding on pre-cut faults in laboratories. AE sources were located on the pre-cut fault and their composite focal-mechanism solution was consistent with that expected theoretically for the macroscopic sliding. These suggest that micro-mechanics of frictional sliding can be known from analyses of AE events. In the present study, a direct-shear experiment was performed to examine a rate dependence of AE activity during the steady-state frictional sliding on a pre-cut fault in a granite sample. The fault surfaces were prepared with #60 abrasive. Cumulative displacement of 65 mm was imposed in a series of experimental runs. The rock sample was unloaded between runs to reset its position. Gauge particles generated by wear of fault surfaces were not removed. AE events were observed by PZT transducers pasted near the center of fault trace on the free surfaces of the rock sample. Amplitude and occurrence time of each peak in the envelopes of AE waveforms were recorded as those of an AE event. The number of AE events per unit displacement, N during the steady-state sliding decreases with sliding. The rate dependence of the N-value, (? N/? ln V)/N, where V is the sliding rate, evolves from negative to positive. The m-value in Ishimoto-Iida's relation increases at the initial displacements where the (a-b)-value in a constitutive law of friction takes a positive value. A negative correlation between the value of ? m/? ln V and the (a-b)-value is observed. The rate dependence of the total seismic energy per unit displacement, (? E/? ln V)/E, where E is the total seismic energy, was calculated from the observed AE activity. If a ratio of the total seismic energy to the frictional energy-loss is independent of the sliding rate, it is expected that the total seismic energy would exhibit the same rate-dependence as friction. The estimated value of (? E/? ln V)/E shows a positive correlation to the (a-b)-value, being qualitatively consistent with the expectation. The value of (? E/? ln V)/E is, however, much larger than the (a-b)-value. This may be because the AEs should be sensitive to a local property of friction, while the (a-b)-value is defined for the macroscopic friction.

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

    PubMed

    Fu, Tian-Jun; Xie, Wen-Fang

    2005-10-01

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

  20. Wear resistance and energy consumption of eutectoid steel during dry sliding

    SciTech Connect

    Wang, Y.; McNallan, M.; Zhang, X.; Lei, T.

    1997-01-15

    Because the wear resistance of a material is related to its microstructure and because changes in microstructure may take place during the wear process, it seems that wear research should emphasize microstructure. However, there are very few reports which have related wear mechanisms to the microstructural changes during sliding wear. Some studies have been made of the relationship between typical microstructures and wear behavior of materials during sliding wear. But, the micromechanisms of the wear of various microstructures are still not clear because the dynamic changes taking place during sliding have not been satisfactorily considered. For the purpose of advancing the understanding, the aim of the present paper is to further investigate the micromechanism of the sliding wear of different microstructures of eutectoid carbon steel through study of the relationship between the wear resistance and the energy consumption of the steel during dry sliding, on the basis of previous work.

  1. 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

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

    PubMed

    Boyce, B F

    2015-07-01

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

  3. 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.

  4. 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.

  5. 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

  6. Metabolic network analysis predicts efficacy of FDA-approved drugs targeting the causative agent of a neglected tropical disease

    PubMed Central

    2012-01-01

    Background Systems biology holds promise as a new approach to drug target identification and drug discovery against neglected tropical diseases. Genome-scale metabolic reconstructions, assembled from annotated genomes and a vast array of bioinformatics/biochemical resources, provide a framework for the interrogation of human pathogens and serve as a platform for generation of future experimental hypotheses. In this article, with the application of selection criteria for both Leishmania major targets (e.g. in silico gene lethality) and drugs (e.g. toxicity), a method (MetDP) to rationally focus on a subset of low-toxic Food and Drug Administration (FDA)-approved drugs is introduced. Results This metabolic network-driven approach identified 15 L. major genes as high-priority targets, 8 high-priority synthetic lethal targets, and 254 FDA-approved drugs. Results were compared to previous literature findings and existing high-throughput screens. Halofantrine, an antimalarial agent that was prioritized using MetDP, showed noticeable antileishmanial activity when experimentally evaluated in vitro against L. major promastigotes. Furthermore, synthetic lethality predictions also aided in the prediction of superadditive drug combinations. For proof-of-concept, double-drug combinations were evaluated in vitro against L. major and four combinations involving the drug disulfiram that showed superadditivity are presented. Conclusions A direct metabolic network-driven method that incorporates single gene essentiality and synthetic lethality predictions is proposed that generates a set of high-priority L. major targets, which are in turn associated with a select number of FDA-approved drugs that are candidate antileishmanials. Additionally, selection of high-priority double-drug combinations might provide for an attractive and alternative avenue for drug discovery against leishmaniasis. PMID:22540944

  7. The characterization of the Frank Slide deposit

    NASA Astrophysics Data System (ADS)

    Charričre, Marie; Pedrazzini, Andrea; Güell Pons, Maria; Volpi, Michele; Jaboyedoff, Michel; Froese, Corey; Kanevski, Mikhaďl.

    2010-05-01

    On the night of the 29th April 1903, approximately 30 millions of cubic meters of limestone slided down the east face of Turtle Mountain (Alberta, Canada). Having killed about 80 people in the village of Frank, the rock avalanche was named after it. The characteristics of this large event are an especially long runout distance of 3 km, a primary fall of 1000 m and an average speed of 30 m/s. The produced deposit has a surface area of 3 km2, its mean thickness is 15 m and it presents an inverse grading with fine grains at its base and boulders at its top. In this study, based on field work, GIS and statistical analysis, more characteristics of the deposit are examined. An analysis of the block size at the surface of the deposit along three profiles is performed in order to determine the granulometry curve of the blocks. This is completed by a remote sensing analysis. Similarly the morphology and lithology of the deposit is studied. The results show a chaotic morphology, a partially homogenous distribution of the geologic formations and a relation between blocks' diameter and the distance to the scarp. In addition, a distinct element numerical model PFC2D is executed to simulate the transportation of this massive rock avalanche. This complete analysis provides information about the fragmentation and propagation processes that took place in 1903. Preliminary outcomes show a significant pattern: the lowest in altitude the lithologies are in the cliff, the furthest they have been transported by the slide. Indeed, the Banff Formation which was positioned at the base of the fallen mass, is presently placed in the distal part of the deposit. The interest of this study is to gather the more details possible on the deposition and transportation in order to understand better the processes that engender the propagation of a large rock avalanche.

  8. 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.…

  9. 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.

  10. 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.…

  11. 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.

  12. Sliding induced crystallization of metallic glass

    NASA Technical Reports Server (NTRS)

    Miyoshi, K.; Buckley, D. H.

    1983-01-01

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

  13. 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. 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

  15. 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

  16. 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).

  17. 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

  18. FDA drug labeling for pregnancy and lactation drug safety monitoring systems.

    PubMed

    Greene, Michael F

    2015-11-01

    The product label required by the FDA for every drug approved for marketing in the US is a legal document that originates with the company that wants to market the drug, but it must be approved by the FDA. Despite the recognized limitations of registries, the FDA's new labeling rule, effective from July 1, 2015, has given the data available from post-marketing surveillance priority in the new label. For this information to be maximally useful to both providers and consumers, providers must refer as many exposed consumers as possible to the registries, preferably prior to knowledge of the outcomes of the pregnancies. Consumers need to cooperate with the registries to share their health information with as much detail as possible with the registries. It will take years to accumulate a meaningful quantity of information in many of the registries, but they promise to be our best hope for useful counseling information in the future. PMID:26428020

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

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

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

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

    PubMed

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices. PMID:15876645

  1. Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?

    PubMed

    Payne, P W

    2014-10-01

    In an effort to prevent potentially fatal adverse reactions to carbamazepine, the US Food and Drug Administration (FDA) issued an alert in 2007 containing pharmacogenomic information, which is still in effect today. The alert states that carbamazepine-induced skin reactions are significantly more common in patients with the human leukocyte antigen (HLA)-B*1502 allele and that these people are almost exclusively from 'broad areas of Asia, including South Asian Indians.' This study reviews the medical evidence relied upon by the FDA and finds that the alert does not accurately reflect the medical evidence relied upon in 2007 or evidence that has been generated over the last 5 years since the label was created. The FDA drug labeling should be modified to reflect current medical evidence. PMID:24752310

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

    NASA Astrophysics Data System (ADS)

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

    2010-05-01

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

  3. SlideToolkit: an assistive toolset for the histological quantification of whole slide images.

    PubMed

    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

  4. 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

  5. Increase in friction force with sliding speed

    NASA Astrophysics Data System (ADS)

    Cross, Rod

    2005-09-01

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

  6. Frictional coupling between sliding and spinning motion.

    PubMed

    Farkas, Zénó; Bartels, Guido; Unger, Tamás; Wolf, Dietrich E

    2003-06-20

    The tangential motion at the contact of two solid objects is studied. It consists of a sliding and a spinning degree of freedom (no rolling). We show that the friction force and torque are inherently coupled. As a simple test system, a sliding and spinning disk on a horizontal flat surface is considered. We calculate, and also measure, how the disk slows down and find that it always stops its sliding and spinning motion at the same moment. We discuss the impact of this coupling between friction force and torque on the physics of granular materials. PMID:12857231

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

    PubMed

    Lykken, Sara

    2013-01-01

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

  8. 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

  9. FDA Internet regulation? Public comment accepted until December 16. Food and Drug Administration.

    PubMed

    1996-11-15

    In 1996, the Food and Drug Administration (FDA) held a meeting concerning advertising and promotion of medical products on the Internet in five discussion groups: chatrooms and newsgroups, additional regulatory issues, Website links, and international issues. Post-meeting comments indicate that the FDA is unlikely to regulate the content of medical information on the Internet, but several issues remain. Pharmaceutical and other companies may be pressured to restrict their information to medical professionals; restrictions may be imposed on information about experimental drugs; and the development of world medicine via Internet access by the public and professionals requires it to become more institutionalized in order to serve more people. PMID:11364003

  10. Exact Sciences' experience with the FDA and CMS parallel review program.

    PubMed

    Ridge, John R; Statz, Sandra

    2015-01-01

    Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer death among men and women combined in the USA. Although the benefits of early CRC detection are widely recognized, screening rates are suboptimal. Cologuard is a multitarget stool DNA screening test that offers a unique non-invasive option for CRC screening. Cologuard was the first product to be reviewed under a pilot parallel review program jointly conducted by the US FDA and the Centers for Medicare & Medicaid Services (CMS). This parallel review process shortened the overall review for Cologuard and resulted in a preliminary National Coverage Determination that coincided with FDA approval. PMID:26211481

  11. FDA working to ensure the safety of medical devices used in the pediatric population.

    PubMed

    Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline

    2012-12-01

    Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. PMID:23116531

  12. 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

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

    NASA Technical Reports Server (NTRS)

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

    1994-01-01

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

  14. Minimum sliding mode error feedback control for fault tolerant small satellite attitude control

    NASA Astrophysics Data System (ADS)

    Cao, Lu; Li, Xiaolong; Chen, Xiaoqian; Zhao, Yong

    2014-01-01

    This paper proposes a new control strategy (which we call "minimum sliding mode error feedback control, MSMEFC") for small satellite attitude control. As we know, the attitude control algorithm plays a significant role in the whole performance of the satellite, especially under the existence of uncertain disturbances from the space. Without loss of generality, the MSMEFC is presented based on the sliding mode theory. It is assumed that the equivalent control error is defined to offset the uncertain disturbances to improve the control performance. Hence, in order to estimate the optimal equivalent control error, a cost function is derived on the basis of the principle of minimum sliding mode error. Then, the equivalent control error wills feedback to the conventional sliding mode control to obtain the final MSMEFC. According to the theoretical analyzes, the sliding mode after the MSMEFC will approximate to the ideal sliding mode, resulting in enhancing the control performance. Moreover, an adaptive non-singular terminal sliding mode is employed to compare with the performance of MSMEFC. Several simulations are performed to verify the effectiveness of proposed MSMEFC in the presence of serious perturbations, even in some fault-tolerant scenarios.

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

    PubMed

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

    2015-02-01

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

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

    PubMed Central

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

    2014-01-01

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

  17. 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.

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

    SciTech Connect

    Argnani, A.; Trincardi, F.

    1988-08-01

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

  19. 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…

  20. 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)

  1. Automated single-slide staining system

    NASA Technical Reports Server (NTRS)

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

    1974-01-01

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

  2. 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)

  3. Slide Rule For Calculating Curing Schedules

    NASA Technical Reports Server (NTRS)

    Heater, Don

    1995-01-01

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

  4. 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…

  5. 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…

  6. 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.

  7. 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…

  8. 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…

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

    PubMed

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

    2014-10-01

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

  10. 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

    ... Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19) AGENCY: Food and Drug Administration, HHS... Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal... Island Sea Lab (DISL). FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the...

  11. 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...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  13. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.171 Utilization...

  14. 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

  15. 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.

  16. 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

  17. Regulatory issues facing the development of drug-eluting stents: a US FDA perspective.

    PubMed

    Boam, Ashley B

    2006-05-01

    Coronary drug-eluting stents (DES) are a breakthrough technology that has changed the standard of care for many patients undergoing percutaneous intervention for coronary artery disease. Initial trials of two DES demonstrated significant clinical benefit with respect to the need for reintervention when compared with bare metal stents. However, more recent studies of DES involve in-patients with more complex disease, such as bifurcation lesions, chronic total occlusions and multiple-vessel disease. Additionally, DES are now being evaluated in patients previously only considered for surgical intervention. Assessment of DES in these complicated patient populations can lead to challenges in trial design, but the US FDA is willing to consider alternative clinical trial designs and statistical analysis plans. Other complex issues associated with DES include duration of clinical trials to determine safety, and the appropriate dose and duration of concomitant antiplatelet therapy. Finally, the FDA acknowledges that DES are complex products to produce and we believe that through interaction with the FDA during development, difficulties with test methodologies, animal studies and clinical trial designs can be addressed. The future of DES likely involves new stent and carrier materials, including biodegradable materials and new drugs and biologicals. The FDA anticipates continued collaboration with physicians, manufacturers, academic institutions and professional societies. PMID:16681451

  18. 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)

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

    PubMed

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

    2015-07-01

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

  20. 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

    ... methods in manufacturing, processing, packing, and holding food and feed. FDA is interested in making... examine and update current good manufacturing practice requirements and to develop an animal feed safety... animal food and feed (including pet food). DATES: See ``How to Participate in the Meeting'' in...