Science.gov

Sample records for fda presentation slides

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

    ERIC Educational Resources Information Center

    Van Buren, Maurie

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

  2. SSP: Sketching Slide Presentations, a Syntactic Approach

    NASA Astrophysics Data System (ADS)

    Mas, Joan; Sanchez, Gemma; Llads, Josep

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

  3. 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)

  4. 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.

  5. 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…

  6. 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

  7. 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)

  8. 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)

  9. Reaching the People: Using a Sound/Slide Budget Presentation.

    ERIC Educational Resources Information Center

    Kerr, Sharon A.

    1994-01-01

    A multimedia (sound/slide) presentation translates numbers of a school budget into a living representation of the schools served by the school district. Such a presentation was tested with positive results in a New York school district. This article was originally submitted for, and the author received, a 1993 Pinnacle of Achievement Award from…

  10. 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

  11. 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

  12. 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…

  13. 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

  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. 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)

  16. 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.

  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. 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

  2. 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)

  3. 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…

  4. 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…

  5. 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

  6. FDA: friend or foe?

    PubMed

    Lewis, T S

    1996-11-01

    Delays in FDA product approvals have weakened the US medical device market. Reduced investment returns and the erosion of industry's confidence in FDA procedures have slowed the introduction of new products and threatened the market's potential for growth. This article examines the background to those issues and describes FDA's attempts to overcome its procedural shortcomings. PMID:10163675

  7. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... characters: Advanced Search Browse by Drug Name A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 Drug Approval Reports by Month Disclaimer FDA/Center for Drug Evaluation and Research Office of Communications Division of Online Communications Update Frequency: Daily - - Links ...

  8. 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 ...

  9. FDA Kids' Home Page

    MedlinePlus

    ... Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact ... Information Safety Emergency Preparedness International Programs News & Events Training ...

  10. FDA 101: Dietary Supplements

    MedlinePlus

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

  11. FDA Certified Mammography Facilities

    MedlinePlus

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

  12. 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…

  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. 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)

  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. 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

  17. 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…

  18. Physics in water slides

    NASA Astrophysics Data System (ADS)

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

    2015-11-01

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

  19. 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)

  20. Preparing for an FDA preapproval inspection.

    PubMed

    Blackmer, R A

    1994-12-01

    During the past several years, the U.S. Food and Drug Administration (FDA) has increased its compliance and enforcement activities in relation to the approval of new pharmaceutical products. FDA has published Compliance Program Guidance Manual 7346.832, "preapproval inspections/investigations," which describes the manner in which FDA will manage this program, as well as describing expectations concerning laboratory and production controls for the development and manufacturing of a new product. This program, and the dialogue that it has stimulated between the agency and the pharmaceutical industry, has helped define contemporary criteria for assessing the validity of scientific and technical data supporting marketing applications. The program focuses on a comparison of the proposed commercial manufacturing process vis-a-vis the methods and controls used to produce supplies utilized in pivotal clinical and bioequivalence studies. This article presents an industry perspective regarding preparation for an FDA preapproval inspection (PAI) for two categories of products: those which were under development before the expectations of the PAI program were fully elucidated and those which are entering the development pipeline today. PMID:7613749

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. Mini Lessons from FDA.

    ERIC Educational Resources Information Center

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

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

  6. FDA-Approved HIV Medicines

    MedlinePlus

    ... but HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. The following table lists HIV medicines approved by the U.S. Food and Drug Administration (FDA) for the treatment of ...

  7. A proposal for FDA reform.

    PubMed

    Miller, Henry I

    2002-08-01

    Since the current system for the regulation of drugs in the United States was established in 1962, the FDA has steadily increased the scope of its responsibilities and activities, and, concomitantly, the regulatory burden on drug developers. The costs and time that are required for drug development have spiralled upwards. Reform of drug regulation is necessary; it must be fundamental in nature, and it must come from outside the agency through new legislation. PMID:12402504

  8. Internet Database Review: The FDA BBS.

    ERIC Educational Resources Information Center

    Tomaiuolo, Nicholas G.

    1993-01-01

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

  9. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

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

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

    PubMed

    Givel, Michael

    2005-12-01

    The objective of this study was to determine whether the 2004 USA Dewine-Kennedy Bill is congruent with Philip Morris' core policy principles for United States Food and Drug Administration (FDA) regulation of tobacco and what impact that would have on the public health. I compared the Dewine-Kennedy Bill with 1999 Philip Morris core policy principles for FDA regulation. Additional supporting data on FDA regulation from 1998 to the present were collected from previously secret tobacco industry documents, relevant newspaper reports from Nexis-Lexis, federal statutes, and federal regulations. The main outcome measure of the study is a comparison, summary, and analysis of the Dewine-Kennedy Bill with Philip Morris' core principles for FDA regulation, and the result is that the Dewine-Kennedy Bill is compatible with almost all of Philip Morris' core principles on FDA regulation. In conclusion, The Dewine-Kennedy Bill, at best, was mixed in terms of the enhancement of the public health. On the one hand, proponents of this legislation argued stronger FDA regulatory requirements would have some effect on reducing youth and adult tobacco consumption. On the other hand, tobacco products would have remained a politically and economically viable and legal product consumed by millions of Americans many of whom would have continued to suffer from tobacco-related illnesses and deaths. PMID:16392744

  11. 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

  12. 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

  13. 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

  14. 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…

  15. 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.

  16. 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.

  17. Planning for effective interaction with FDA.

    PubMed

    Spurgin, Elizabeth A

    2004-12-01

    Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets. PMID:15684628

  18. 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: ...

  19. 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 ...

  20. FDA Approves Implant to Battle Opioid Addiction

    MedlinePlus

    ... fullstory_159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing eliminates need to ... Thursday by the U.S. Food and Drug Administration. "Opioid abuse and addiction have taken a devastating toll ...

  1. FDA Launches Ad Campaign Against Chewing Tobacco

    MedlinePlus

    ... for fans to meet players who support the campaign's public health message, she said. The FDA also is in ongoing talks with Major League Baseball about joining the campaign, and Zeller said he is "optimistic" that a ...

  2. Pharmacogenomic biomarker information in FDA-approved paediatric drug labels.

    PubMed

    Kim, Therasa; Han, Nayoung; Sohn, Minji; Oh, Jung Mi; Lee, Eui-Kyung; Ji, Eunhee; Kim, In-Wha

    2015-05-01

    Gene maturation differs between paediatric and adult populations, and the extrapolation of adult pharmacogenomic information to paediatrics is not always appropriate. We sought to determine the extent of paediatric pharmacogenomic trial translation into US FDA-approved labels and to evaluate needs for biomarker studies. Using FDA's Table of Genomic Biomarkers and Drugs@FDA website, 38 pharmacogenomic biomarkers in 56 drug labels were identified with possible application in paediatrics. Of these 56 drugs, biomarker comparison against 'Very Important Pharmacogenes (VIPs)' defined in PharmGKB's database revealed a total of eight VIPs labelled among 41 drugs. One hundred and thirty-nine product reviews posted on the FDA website under the Best Pharmaceuticals for Children Act and Paediatric Research Equity Act between October 2007 and July 2014 were examined. Review screening identified 43 drugs with 'pharmacogenomic' content, of which only three were true genotyping study reviews for proton pump inhibitors, all evaluating CYP2C19 polymorphisms. Pantoprazole was the sole drug labelled with pharmacogenomic information obtained specifically from paediatric trials. Clinicaltrials.gov was searched to further evaluate the current availability of pharmacogenomic studies in the paediatric population. Of the 33,132 trials registered on Clinicaltrials.gov, 137 were labelled as paediatric pharmacogenetic and pharmacogenomic studies. Pharmacogenomic studies directly conducted in paediatric patients are lacking, and thus, pharmacogenomic biomarker information based on adult studies is commonly presented in FDA-approved labels for use in paediatric patients. Considering differences in gene expression and physiological maturation between paediatric and adult populations, studies investigating pharmacogenomic effects specifically in paediatric patients should be conducted whenever significant biomarkers are available. PMID:25348905

  3. 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

    ... HUMAN SERVICES Food and Drug Administration Implementation of the FDA Food Safety Modernization Act... comment period for the notice entitled ``Implementation of the FDA Food Safety Modernization Act Provision... Food Safety Modernization Act (FSMA), and as it implements the FSMA provisions relating to......

  4. 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...

  5. 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)...

  6. 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...

  7. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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)...

  14. 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)...

  15. 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)...

  16. 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...

  17. 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...

  18. 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)...

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

    PubMed

    Kelley, Peter

    2010-01-01

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

  20. 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 Güvenc, 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.

  1. Sliding vane geometry turbines

    SciTech Connect

    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.

  2. FDA's new drug evaluation process: a general overview.

    PubMed

    Walters, P G

    1992-01-01

    A general overview of the FDA new-drug evaluation process is presented with special emphasis on the regulatory requirements as outlined in the federal Food, Drug, and Cosmetic Act and the interpretive New Drug Regulations. Included is a description of the administrative/scientific makeup and functions of the new-drug evaluation divisions within the Center for Drug Evaluation and Research. Some specifics relating to the investigative development of anticaries and plaque/gingivitis new drug products are discussed. PMID:1432918

  3. The FDA and the new biology.

    PubMed

    Simari, Robert D; Chen, Horng; Burnett, John C

    2008-12-01

    The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval. PMID:20559929

  4. 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

  5. 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 orinjury. With expanding indications for its use at tertiary centers, salvage techniques for dehiscence or restenosis after slide tracheoplasty are increasingly relevant. Wepresent 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

  6. Regulating nanomedicine - can the FDA handle it?

    PubMed

    Bawa, Raj

    2011-05-01

    There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle nanomedicine research and development (R&D) and erode public acceptance of nanoproducts. The end-result of this could be a delay or loss of commercialized nanoproducts. Whether the FDA eventually creates new regulations, tweaks existing ones or establishes a new regulatory center to handle nanoproducts, for the time being it should at least look at nanoproducts on a case-by-case basis. The FDA should not attempt regulation of nanomedicine by applying existing statutes alone, especially where scientific evidence suggests otherwise. Incorporating nanomedicine regulation into the current regulatory scheme is a poor idea. Regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection and safety. PMID:21291376

  7. 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…

  8. Flexible sliding seal

    NASA Technical Reports Server (NTRS)

    Wallenhorst, E. L.

    1980-01-01

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

  9. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

    Background Cincinnati Childrens 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 Administrations (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

  10. 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' ...

  11. Herbaceous Ornamental Plants. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with commercially important herbaceous ornamental plants. Included in the script are narrations for use with a total of 338 slides illustrating 150 different plants. Generally, two slides are used to illustrate each plant: one slide shows…

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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)...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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)...

  3. 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)...

  4. 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...

  5. 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...

  6. 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...

  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 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...

  14. 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...

  15. 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…

  16. 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

  17. 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...

  18. 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.

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

    PubMed Central

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

    2010-01-01

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

  20. 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

  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. Slides, Swings and Science.

    ERIC Educational Resources Information Center

    Dreyer, Kay Jardon; Bryte, Janelle

    1990-01-01

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

  3. Prototype Slide Stainer

    NASA Technical Reports Server (NTRS)

    1971-01-01

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

  4. Prototype slide stainer

    NASA Technical Reports Server (NTRS)

    1971-01-01

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

  5. 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…

  6. 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…

  7. Selected Landscape Plants. Slide Script.

    ERIC Educational Resources Information Center

    McCann, Kevin

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

  8. 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

  9. 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

  10. US FDA oncology drug approvals in 2014.

    PubMed

    Wolford, Juliet E; Tewari, Krishnansu S

    2015-01-01

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

  11. 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

  12. Target selection for FDA-approved medicines.

    PubMed

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

    2015-07-01

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

  13. 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

  14. 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.

  15. Quasistatic manipulation with compliance and sliding

    SciTech Connect

    Kao, I. ); Cutkosky, M.R. )

    1992-02-01

    The authors propose a method for modeling dextrous manipulation with sliding fingers. The approach combines compliance and friction limit surfaces. The method is useful for describing how a grasp will behave in the presence of external forces (e.g., when and how the fingertips will slide) and for planning how to control the fingers so that the grasped object will follow a desired trajectory. The sliding trajectories are characterized by a transient and steady-state solution. The underlying theory is first discussed and illustrated with several single-finger examples. Experimental results are also presented. The analysis is then extended to grasps with multiple sliding and nonsliding fingers. The multifinger analysis is illustrated with an example of manipulating a card with two soft-contact fingers.

  16. Sliding PCA Fuzzy Clustering Algorithm

    NASA Astrophysics Data System (ADS)

    Salgado, Paulo; Gonçalves, Lio; Igrejas, Getúlio

    2011-09-01

    This paper proposes a new robust approach to nonlinear clustering based on the Principal Component Analysis (PCA) approach. A robust c-means partition is derived by using the natural PCA noise-rejection mechanism and the nonlinearity captured by a sliding process of the clusters prototype. A non-linear extension of PCA has been developed for detecting the lower-dimensional representation of real world data sets. For these cases local linear approaches are used widely because of their computational simplicity and understandability. We will present a new method that joins (merges) the fuzzy clustering algorithm with a local sliding PCA analysis. With this strategy it is possible to identify the non-linear relations and obtain morphological information of the data. The Sliding PCA-Fuzzy cluster algorithm (SPCA-FCA) is a fuzzy clustering algorithm that estimates local principal component vectors as the vectors spanning prototypes of clusters, performed on the neighborhood of the center of cluster and normal approximations in order to estimate a tangent surface that characterizes the trend and curvature of the data points or contours region. Numerical experiments demonstrate that the proposed method is useful for capturing cluster cores by rejecting noise samples, and we can easily assess cluster validity by using cluster-crossing curves.

  17. Interpreting patient-reported outcome results: US FDA guidance and emerging methods.

    PubMed

    McLeod, Lori D; Coon, Cheryl D; Martin, Susan A; Fehnel, Sheri E; Hays, Ron D

    2011-04-01

    In recent years, the US FDA has become more critical of instruments used to measure patient-reported outcomes (PROs) in clinical trials. To facilitate decisions related to the approval of drugs, labels and promotional claims based on PROs, the FDA created the Study Endpoints and Label Development (SEALD) group. SEALD has developed a PRO guidance related to the use of PRO measures used to support drug approvals and label claims, including recommendations for establishing thresholds for meaningful change at the individual level (i.e., defining a responder). This article examines in detail the FDA-recommended methodology for defining a responder and analyzing responder-based PRO measure results. We also present other responder analysis approaches for consideration in furthering the precision and interpretation of this methodology. PMID:21476818

  18. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access...

  19. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  1. 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. The Division of Dockets Management public room...

  2. 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

  3. 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.

  4. 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…

  5. 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)

  6. Reversing the Slide

    ERIC Educational Resources Information Center

    Gallagher, Michael

    2005-01-01

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

  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. 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

    ... and FDA's decision-making and that (2) individuals invited as advisory committee members would agree.... 02D-0049, now Docket No. FDA- 2002-D-0094, 67 FR 6545, February 12, 2002). The draft guidance was... comment (72 FR 61657, October 31, 2007). The Agency reviewed the submitted comments on the January...

  9. 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

  10. Computer Slide Shows: A Trap for Bad Teaching

    ERIC Educational Resources Information Center

    Klemm, W. R.

    2007-01-01

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

  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. Application of partial sliding mode in guidance problem.

    PubMed

    Shafiei, M H; Binazadeh, T

    2013-03-01

    In this paper, the problem of 3-dimensional guidance law design is considered and a new guidance law based on partial sliding mode technique is presented. The approach is based on the classification of the state variables within the guidance system dynamics with respect to their required stabilization properties. In the proposed law by using a partial sliding mode technique, only trajectories of a part of states variables are forced to reach the partial sliding surfaces and slide on them. The resulting guidance law enables the missile to intercept highly maneuvering targets within a finite interception time. Effectiveness of the proposed guidance law is demonstrated through analysis and simulations. PMID:23260528

  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. 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.

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

    MedlinePlus

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

  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 Warns of Lead Poisoning Risk from Cosmetic Clay

    MedlinePlus

    ... FDA Warns of Lead Poisoning Risk From Cosmetic Clay Agency tells users of Bentonite Me Baby to ... FRIDAY, Jan. 29, 2016 (HealthDay News) -- A beauty clay sold at major retail outlets may put users ...

  18. FDA Approves New Drug to Treat Bladder Cancer

    MedlinePlus

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

  19. FDA OKs 'Containment' Bag for Certain Uterine Surgeries

    MedlinePlus

    ... gov/medlineplus/news/fullstory_158195.html FDA OKs 'Containment' Bag for Certain Uterine Surgeries But most women ... it would permit limited use of a "tissue containment system" in conjunction with laparoscopic power morcellators -- devices ...

  20. FDA recognition of consensus standards in the premarket notification program.

    PubMed

    Marlowe, D E; Phillips, P J

    1998-01-01

    "The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors. PMID:9619259

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

    PubMed

    Knapp, Veronica

    2011-01-01

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

  2. 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.

  3. "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.

  4. 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...

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. Develop and Manufacture an airlock sliding tray

    SciTech Connect

    Lawton, Cindy M.

    2014-02-26

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

  10. 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-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

  12. FDA perspectives on health claims for food labels.

    PubMed

    Rowlands, J Craig; Hoadley, James E

    2006-04-01

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

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

    PubMed

    Kay, G

    2001-01-01

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

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

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

    PubMed

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

    2015-05-01

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

  15. 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/

  16. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 316.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of... written notice recognizing exclusive approval once the marketing application for a designated...

  17. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request... determining whether a patent related to a product is eligible for patent term restoration as follows: (1... use; (2) For human drug products, food additives, color additives, and medical devices,...

  18. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request... determining whether a patent related to a product is eligible for patent term restoration as follows: (1... use; (2) For human drug products, food additives, color additives, and medical devices,...

  19. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request... determining whether a patent related to a product is eligible for patent term restoration as follows: (1... use; (2) For human drug products, food additives, color additives, and medical devices,...

  20. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request... determining whether a patent related to a product is eligible for patent term restoration as follows: (1... use; (2) For human drug products, food additives, color additives, and medical devices,...

  1. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... TERM RESTORATION Eligibility Assistance § 60.10 FDA assistance on eligibility. (a) Upon written request... determining whether a patent related to a product is eligible for patent term restoration as follows: (1... use; (2) For human drug products, food additives, color additives, and medical devices,...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405.203 Section 405.203 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health...

  3. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... process. Such communication may take the form of telephone conversations, letters, or meetings, whichever... for communication between FDA and applicants are contained in a staff manual guide that is publicly... application needed to facilitate the agency's review. This early communication is intended to...

  4. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  5. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  6. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  7. 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... Spring, MD 20993, Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy., College Park, MD...

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

    .... See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. Submit electronic... In the February 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing...., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the...

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. Effective Use of Slides for Bibliographic Instruction.

    ERIC Educational Resources Information Center

    Crowe, Kathy Moore

    1989-01-01

    Describes the use of slides for bibliographic instruction at the University of North Carolina at Greensboro. The advantages of a slide/lecture format and the cost of slides are discussed, and tips for producing and using slides are offered. (nine references) (MES)

  19. 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

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

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

    PubMed

    Bastiampillai, Tarun; Gupta, Arun; Allison, Stephen

    2016-06-01

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

  6. 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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  8. 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...

  9. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  10. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

  11. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention...

  12. 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 ...

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

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Safety Home Safety MedWatch The FDA Safety Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet ...

  14. Accounting for heterogeneous treatment effects in the FDA approval process.

    PubMed

    Malani, Anup; Bembom, Oliver; van der Laan, Mark

    2012-01-01

    The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients to respond differently to a drug. Therefore, the average-patient standard can reject a drug that benefits certain patient subgroups (false negatives) and even approve a drug that harms other patient subgroups (false positives). These errors increase the cost of drug development - and thus health care - by wasting research on unproductive or unapproved drugs. The reason why the FDA sticks with an average patient standard is concern about opportunism by drug companies. With enough data dredging, a drug company can always find some subgroup of patients that appears to benefit from its drug, even if the subgroup truly does not. In this paper we offer alternatives to the average patient standard that reduce the risk of false negatives without increasing false positives from drug company opportunism. These proposals combine changes to institutional design - evaluation of trial data by an independent auditor - with statistical tools to reinforce the new institutional design - specifically, to ensure the auditor is truly independent of drug companies. We illustrate our proposals by applying them to the results of a recent clinical trial of a cancer drug (motexafin gadolinium). Our analysis suggests that the FDA may have made a mistake in rejecting that drug. PMID:24624647

  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. Large scale NEMD simulations of polycrystalline Al sliding interfaces

    NASA Astrophysics Data System (ADS)

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

    2012-02-01

    We present the results of NonEquilibrium Molecular Dynamics (NEMD) simulations for the frictional force between polycrystalline Al samples. Polycrystalline Al samples of order 26M atoms with grain sizes from 10 - 20 nm at compressions of 15 GPa are condsidered as a function of sliding velocity . Typical sample dimensions are 58nm in the sliding and transverse directions and 116nm in the direction normal to the sliding interface. A constant temperature (300K) and constant tangential velocity boundary condition is imposed at the boundaries in the direction normal to the sliding plane. We discuss the modes of plastic deformation and polycrystalline deformation which determine the steady state frictional force and compare these results with results for defect free Al single crystals and highly defective Al single crystal samples.

  17. 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

  18. 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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I FDA Food Safety Modernization Act: Focus on... a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive Controls for... implementation of the preventive controls for facilities provisions of the recently enacted FDA Food...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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....

  6. 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...

  7. 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What criteria does FDA use to order a detention? 1... General 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...

  9. 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....

  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. 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....

  14. 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...

  15. 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....

  16. 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...

  17. 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,...

  18. 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....

  19. 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....

  20. 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...

  1. 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....

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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....

  7. 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...

  8. Virtual slides: application in pulmonary pathology consultations.

    PubMed

    Słodkowska, Janina; Chyczewski, Lech; Wojciechowski, Michał

    2008-01-01

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

  9. 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.

  10. 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.

  11. 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

  12. Pharmacometrics at FDA: evolution and impact on decisions.

    PubMed

    Powell, J R; Gobburu, J V S

    2007-07-01

    Drug development and regulatory decisions are driven by information that is compiled primarily from clinical trials and other supportive experiments, but also through clinical experience in the post-market period. The wisdom of these decisions determines the efficiency of drug development, the decision to approve the drug, and the resultant drug product quality including guidance on how to use the product known as the label. Although the decisions are usually simple in nature (e.g., trial design and project progression at the company, product and labeling approval at the Food and Drug Administration (FDA)), the information informing the decision is complex and diverse. PMID:17538553

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

    PubMed

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

    2014-04-01

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

  14. 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…

  15. 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.

  16. Smoke Conditions from Slide Fire

    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 (...

  17. Heavy duty complete extension slides

    NASA Astrophysics Data System (ADS)

    Bueno, José Ignacio; Vázquez, Javier

    2001-09-01

    The selection from available commercial market of a set of slides to be used in an habitable pressurised module in space, to draw a 660 mm box out of a rack, up to a completely extracted position in a safely supported configuration, seems in principle not to be a complicated task. That was the first approach taken in the design process of the telescopic guides of the Crew Work Bench (CWB) included in the Fluid Science Laboratory (FSL), part of "ESA Microgravity Facilities for Columbus" within the Columbus Orbital Facility (COF) of the International Space Station (ISS). Nevertheless, common space compatible requirements such as materials, specific environmental loads, available envelope, total weight, etc., can make the selection of telescopic slides from commercial market unfeasible. A specific development to design space compatible telescopic slides for the CWB was undertaken. A set of heavy duty space compatible telescopic slides were designed, manufactured and tested. They should be operative in both, 1-g environment and in orbit, and additionally should withstand an inadvertent astronaut kick or bump of 556 N in any direction.

  18. 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

  19. 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

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

    NASA Astrophysics Data System (ADS)

    Keum, Jung-Hoon; Ra, Sung-Woong

    2009-12-01

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

  1. 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

  2. Linear Classification of Dairy Cattle. Slide Script.

    ERIC Educational Resources Information Center

    Sipiorski, James; Spike, Peter

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

  3. Diseases of Landscape Ornamentals. Slide Script.

    ERIC Educational Resources Information Center

    Powell, Charles C.; Sydnor, T. Davis

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

  4. On-Line Retrieval of Clinical Slides.

    ERIC Educational Resources Information Center

    Milgrom, Linda

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

  5. Mannheim Type Slide Rule with Leather Sleeve

    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...

  6. 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…

  7. 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)

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

    NASA Technical Reports Server (NTRS)

    Raj, S. V.

    1991-01-01

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

  9. 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

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

    DOEpatents

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

    2013-01-15

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

  11. 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.

  12. 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.

  13. 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... therapeutic product labeling; provides guidance for industry and FDA staff on possible premarket regulatory... (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``In...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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.

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

    NASA Astrophysics Data System (ADS)

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

    1995-06-01

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

  3. 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

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

    PubMed

    Do, Kathy T; Galvn, 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

  5. 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.

  6. 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

  7. FDA perspective on antivirals against biothreats: communicate early and often.

    PubMed

    Roberts, Rosemary; Styrt, Barbara; McCune, Susan

    2008-04-01

    Development of antiviral products for certain highly pathogenic viruses with limited available treatments, such as viruses that may have biothreat potential, is critically important and challenging. The mission of the FDA is to protect the public health by assuring the safety, efficacy and quality of such products. Human clinical trials are critically important whenever relevant naturally occurring diseases can appropriately be studied. In selected situations when clinical studies are not ethical and field efficacy studies are not feasible, the Animal Rule (67 FR 37988, 2002) introduces the possibility of drug/biologic approval/licensure based on efficacy studies in animals, and appropriate human safety and pharmacokinetic information. This approach necessitates the development of well-delineated animal models predictive of human disease and treatment responses, and plans for adding human information if suitable circumstances arise. Efficient development of therapeutics against these agents requires collaborative efforts among industry, academia and federal agencies. PMID:18037169

  8. 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

  9. 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

  10. 21 CFR 14.15 - Committees working under a contract with FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE General Provisions § 14.15 Committees working under a contract with FDA. (a) FDA may...

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

    PubMed

    Solberg, Brooke L

    2012-01-01

    Recent advances in technology have brought forth an intriguing new tool for teaching hematopoietic cellular identification skills: the digital slide. Although digitized slides offer a number of appealing options for educators, little research has been done to examine how their utilization would impact learning outcomes. To fill that void, this study was designed to examine student performance, skill retention and transferability, and self-efficacy beliefs amongst undergraduate MLS students learning cellular morphology with digital versus traditional slides. Results showed that students learning with digital slides performed better on assessments containing only traditional slide specimens than students learning with traditional slides, both immediately following the learning activity and after a considerable duration of time. Students learning with digital slides also reported slightly higher levels of self-efficacy related to cellular identification. The findings of this study suggest that students learning cellular identification skills with digital slides are able to transfer that skill directly to traditional slides, and that their ability to identify cells is not negatively affected in present or future settings. PMID:23397880

  12. 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…

  13. Science documentary video slides to enhance education and communication

    NASA Astrophysics Data System (ADS)

    Byrne, J. M.; Little, L. J.; Dodgson, K.

    2010-12-01

    Documentary production can convey powerful messages using a combination of authentic science and reinforcing video imagery. Conventional documentary production contains too much information for many viewers to follow; hence many powerful points may be lost. But documentary productions that are re-edited into short video sequences and made available through web based video servers allow the teacher/viewer to access the material as video slides. Each video slide contains one critical discussion segment of the larger documentary. A teacher/viewer can review the documentary one segment at a time in a class room, public forum, or in the comfort of home. The sequential presentation of the video slides allows the viewer to best absorb the documentary message. The website environment provides space for additional questions and discussion to enhance the video message.

  14. 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.

  15. 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...

  16. 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…

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

    NASA Astrophysics Data System (ADS)

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

    2012-10-01

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

  18. 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…

  19. 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

  20. 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

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

    PubMed

    Nowak, Marian; Sayers, Pat; Ashton, Kathleen

    2014-07-01

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

  2. The Edison Environmental Center Permeable Pavement Site - slides

    EPA Science Inventory

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

  3. 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. Role of FDA in establishing tolerable levels for dioxin and PCBs in aquatic organisms.

    PubMed

    Boyer, I J; Kokoski, C J; Bolger, P M

    1991-05-01

    When fishery products shipped in interstate commerce contain an environmental contaminant that presents a potential threat to public health, the Food and Drug Administration (FDA) undertakes appropriate regulatory steps to minimize exposure. These efforts range from seizure of the affected product to formal rule-making to establish a limit. The basic provision of the Food, Drug, and Cosmetic (FD&C) Act by which the agency deals with environmental contaminants in the food supply is section 402(a)(1), which deals with poisonous and deleterious substances. Poisonous and deleterious components are deemed to be "added," even if they are natural constituents of food, if any amount is present through the artifice of man. Furthermore, when the level of a naturally occurring toxin is increased in the food through handling and/or processing, the sum of all of the contaminant is deemed to be "added." Unavoidable environmental contaminants may be controlled and/or regulated under this section by the "may render injurious" standard, whereby the agency must demonstrate that there is a significant possibility that exposure to the contaminant could be injurious to human health. "Action levels" are administrative guidelines or instructions to the agency field units that define the extent of contamination at which the agency may regard food as adulterated. Except for polychlorinated biphenyls, for which there is a tolerance established by regulation, FDA has controlled contaminants in aquatic organisms by using action levels. Under section 406 of the FD&C act, the agency can also establish tolerances for unavoidably added poisonous or deleterious substances. This section allows the agency to consider the extent to which a contaminant is unavoidable in food while it limits exposure to the extent necessary to protect the public health. Section 406 requires that the tolerance be established by assessing several factors, including risk. One of these is the capability of processing technology to prevent, reduce, or otherwise control the level of the contaminant. Another factor is the necessity to avoid the needless removal of large amounts of valuable food from the market. Finally, the available analytical and sampling methods must be capable of measuring the contaminant so as to ensure the enforceability of the tolerance. Although the FDA has no statutory authority over intrastate fishing considerations, such as noncommercial fishing, it does provide advice to local or state authorities. It is the best scientific opinion the agency can give, but it is not enforceable per se. Advice is provided when requested by local and state officials where no guideline or tolerance is available, and is meant to deal with local and/or regional public health concerns.(ABSTRACT TRUNCATED AT 400 WORDS) PMID:1903454

  5. 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)

  6. Dynamical chiral symmetry breaking in sliding nanotubes.

    PubMed

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

    2009-03-27

    We discover in simulations of sliding coaxial nanotubes an unanticipated example of dynamical symmetry breaking taking place at the nanoscale. While both nanotubes are perfectly left-right symmetric and nonchiral, a nonzero angular momentum of phonon origin appears spontaneously at a series of critical sliding velocities, in correspondence with large peaks of the sliding friction. The nonlinear equations governing this phenomenon resemble the rotational instability of a forced string. However, several new elements, exquisitely "nano" appear here, with the crucial involvement of umklapp and of sliding nanofriction. PMID:19392294

  7. A history of slide rules for blackbody radiation computations

    NASA Astrophysics Data System (ADS)

    Johnson, R. Barry; Stewart, Sean M.

    2012-10-01

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

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled..., 0910-0291, 0910-0308, and 0910-0636. IV. Electronic Access Persons with access to the Internet...

  9. 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)

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... appropriate, and other forms of information technology. FDA Form 3728, Animal Generic Drug User Fee Act Cover... track user fees. FDA estimates the burden of this collection of information as follows: ] Table 1... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities;...

  19. 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

  20. 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,...

  1. 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 ...

  2. 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…

  3. 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.

  4. 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

  5. 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

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

    PubMed

    Xiao, Lingfei; Zhu, Yue

    2014-07-01

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

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

    NASA Astrophysics Data System (ADS)

    Karachevtseva, Iuliia; Dyskin, Arcady; Pasternak, Elena

    2015-04-01

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

  8. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2007-12-01

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

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

    PubMed

    Boyce, B F

    2015-07-01

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

  11. A fantastic voyage for sliding bacteria.

    PubMed

    Shrout, Joshua D

    2015-05-01

    A recent study showed that Salmonella enterica serovar Typhimurium exhibits sliding motility under magnesium-limited conditions. Overall, bacteria that exhibit this passive surface movement described as sliding share few common traits. This discovery provides an opportunity to revisit and better characterize appendage-independent bacterial motility. PMID:25777934

  12. 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.

  13. 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.

  14. 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.…

  15. 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

  16. 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

  17. Peeling, sliding, pulling and bending

    NASA Astrophysics Data System (ADS)

    Lister, John; Peng, Gunnar

    2015-11-01

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

  18. Have Thoracic Endografting Outcomes Improved Since FDA Approval?

    PubMed Central

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

    2011-01-01

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

  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. 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.

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

    PubMed

    Eker, Ilyas

    2006-01-01

    In this study, a sliding mode control system with a proportional+integral+derivative (PID) sliding surface is adopted to control the speed of an electromechanical plant. A robust sliding mode controller is derived so that the actual trajectory tracks the desired trajectory despite uncertainty, nonlinear dynamics, and external disturbances. The proposed sliding mode controller is chosen to ensure the stability of overall dynamics during the reaching phase and sliding phase. The stability of the system is guaranteed in the sense of the Lyapunov stability theorem. The chattering problem is overcome using a hyperbolic function for the sliding surface. Experimental results that are compared with the results of conventional PID verify that the proposed sliding mode controller can achieve favorable tracking performance, and it is robust with regard to uncertainties and disturbances. PMID:16480115

  2. 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

  3. What's next after 50 years of psychiatric drug development: an FDA perspective.

    PubMed

    Laughren, Thomas P

    2010-09-01

    This article discusses changes in psychiatric drug development from a US Food and Drug Administration (FDA) standpoint. It first looks back at changes that have been influenced by regulatory process and then looks forward at FDA initiatives that are likely to affect psychiatric drug development in the future. FDA protects the public health by ensuring the safety and efficacy of drug products introduced into the US market. FDA works with drug sponsors during development, and, when applications are submitted, reviews the safety and efficacy data and the proposed labeling. Drug advertising and promotion and postmarketing surveillance also fall within FDA's responsibility. Among the many changes in psychiatric drug development over the past 50 years, several have been particularly influenced by FDA. Populations studied have expanded diagnostically and demographically, and approved psychiatric indications have become more focused on the clinical entities actually studied, including in some cases specific symptom domains of recognized syndromes. Trial designs have become increasingly complex and informative, and approaches to data analysis have evolved to better model the reality of clinical trials. This article addresses 2 general areas of innovation at FDA that will affect psychiatric drug development in years to come. Several programs falling under the general heading of the Critical Path Initiative, ie, biomarkers, adaptive design, end-of-phase 2A meetings, and data standards, are described. In addition, a number of important safety initiatives, including Safety First, the Sentinel Initiative, the Safe Use Initiative, and meta-analysis for safety, are discussed. PMID:20923624

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

    PubMed Central

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

    2016-01-01

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

  5. 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

  6. 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).

  7. 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

    ... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  8. 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

  9. 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

  10. 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.

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    MedlinePlus

    ... 157780.html Don't Take Short Cuts With Contact Lens Care, FDA Warns Solutions with hydrogen peroxide ... March 15, 2016 (HealthDay News) -- If you use contact lens solution with hydrogen peroxide and don't ...

  16. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption What Is the Appeal Process for A Detention Order? § 1.405 When does FDA have to issue a...

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

    MedlinePlus

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

  18. FDA: Wait a Month to Donate Blood After Travel to Zika-Prone Areas

    MedlinePlus

    ... medlineplus/news/fullstory_157278.html FDA: Wait a Month to Donate Blood After Travel to Zika-Prone ... have symptoms that suggest infection, should wait a month before donating blood, the U.S. Food and Drug ...

  19. The FDA process for the evaluation and approval of orthopaedic devices.

    PubMed

    Kirkpatrick, John S; Stevens, Theodore

    2008-05-01

    The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed to ensure public safety. Divisions within the FDA provide specific expertise regarding drugs, devices, biologic products, and combinations thereof. Various pathways exist to apply for marketing through the FDA, depending on the nature of the product and its intended use. Expert panels advise the agency on issues related to product safety and efficacy, and clinical studies may be required to provide data based on these parameters. Clinical data are monitored postapproval for potential adverse events not evident in earlier trials. Orthopaedic surgeons are involved in all aspects of the FDA as employees, consultants, product advocates, participants in clinical trials and advisory panels, and experts involved in the appropriate reporting of adverse events. PMID:18460686

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

    MedlinePlus

    ... FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk Warning pertains to drugs containing saxagliptin or ... saxagliptin and alogliptin may raise the risk of heart failure, particularly in patients with heart or kidney disease, ...

  1. 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

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

  3. 21 CFR 803.3 - How does FDA define the terms used in this part?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false How does FDA define the terms used in this part? 803.3 Section 803.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING; (Eff. Until 8-14-15) General Provisions § 803.3 How does FDA define the terms used in...

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

    PubMed

    Huang, Fanghua

    2010-04-01

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

  5. 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

  6. 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...

  7. 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...

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

    PubMed Central

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

    1988-01-01

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

  9. 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.

  10. 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

  11. 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

  12. 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

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

    PubMed

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

    2016-05-01

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

  14. 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

  15. 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.

  16. 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)

  17. Foam-filled cushions for sliding trays

    NASA Technical Reports Server (NTRS)

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

    1980-01-01

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

  18. 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.

  19. 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.

  20. Antiwear Additive Mechanisms in Sliding Contacts

    NASA Technical Reports Server (NTRS)

    Baldwin, B. A.

    1984-01-01

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

  1. Interfacial dynamnics at sliding Ta/Al interfaces

    NASA Astrophysics Data System (ADS)

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

    2002-03-01

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

  2. 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.

  3. Speckle tracking technology for quantifying lung sliding.

    PubMed

    Dori, Guy; Jakobson, Daniel J

    2016-06-01

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

  4. 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…

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

    ERIC Educational Resources Information Center

    Still, Steven

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

  6. 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

  7. 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.

  8. 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

  9. 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

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

    NASA Astrophysics Data System (ADS)

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

    2008-06-01

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

  11. Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators

    PubMed Central

    Blair Holbein, M. E.; Berglund, Jelena Petrovic

    2012-01-01

    Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting clinical research. The regulatory authority of the FDA extends to clinical studies of medical devices. Consequently, researchers wishing to conduct device research using FDA-approved as well as non-approved devices must comply with federal regulations for Investigational Device Exemptions (IDE) as described in Title 21 of the Code of Federal Regulations Part 812. FDA regulatory oversight is structured to match the risk to the subject to the risk of the device. Medical device studies can be categorized as 1) meeting exemption criteria, 2) being a non-significant risk device, or 3) being a significant risk device. All IDE studies must meet regulations for the protection of human subjects, but no additional federal filing on the part of the investigator is necessary for those that meet exempt criteria. Non-significant risk device studies require meeting abbreviated IDE regulatory requirements for the conduct of the study, but no prior FDA approval is required. Significant risk device studies require that the investigator also function as a sponsor and to file an IDE with the FDA for approval before starting. A Sponsor-Investigator filing an IDE follows the format and content described in 21 CFR 812.20. The study may begin 30 days after the date of submission receipt unless the FDA notifies the sponsor otherwise. While the IDE is active, the Sponsor-Investigator must meet the requirements for the conduct of the study and the required monitoring and reporting to the FDA. PMID:22847340

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

    USGS Publications Warehouse

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

    1988-01-01

    A 4000-km2 area of submarine slump and slide deposits along the W flank of Mauna Loa volcano has been mapped with GLORIA side-scan sonar images, seismic reflection profiles, and new bathymetry. The youngest deposits are 2 debris avalanche lobes that travelled from their breakaway area near the present shoreline as much as 100 km into the Hawaiian Deep at water depths of 4800 m. The 2 lobes partly overlap and together are designated the Alika slide. They were derived from the same source area and probably formed in rapid succession. Slumping on Mauna Loa has been most intense adjacent to the large arcuate bend in its SW rift zone, as the rift zone migrated westward away from the growing Kilauea volcano. Slumping events were probably triggered by seismic activity accompanying dike injection along the rift zone. Such massive slumps, landslides and distal submarine turbidity flows appear to be widespread on the flanks of Hawaiian volcanoes.-from Authors

  13. Finite-time sliding mode synchronization of chaotic systems

    NASA Astrophysics Data System (ADS)

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

    2014-10-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2003-01-01

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

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

    SciTech Connect

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

    2014-03-15

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

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

    NASA Astrophysics Data System (ADS)

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

    2012-11-01

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

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

    NASA Astrophysics Data System (ADS)

    Yuan, Lei; Wu, Han-Song

    2010-12-01

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

  18. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    PubMed

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. PMID:24347043

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

    PubMed

    Rulis, Alan M; Levitt, Joseph A

    2009-02-01

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

  20. Studies found plastic condom unsafe, yet FDA cleared it for market. Food and Drug Administration.

    PubMed

    1995-05-01

    Five unpublished studies, primarily funded by the National Institute of Child Health and Human Development (NICHD), found that Avanti condoms broke at an overall rate more than four times greater than latex condoms. Avanti, the first male polyurethane condom, was approved by the Food and Drug Administration (FDA) in 1991, before the agency began requiring manufacturers of medical devices to perform extensive clinical testing prior to marketing. FDA officials now acknowledge that allowing the innovative condom on the market without clinical efficacy data was a mistake. However, rather than recalling the condom, the FDA is requesting that both the NICHD and the company that manufactured Avanti retest the condom. Avanti is the first latex-free, HIV-impermeable condom available to the estimated five percent of the population that is allergic to latex. According to the FDA, denying those users the condom until efficacy studies are completed is not an option with the AIDS epidemic. However, the FDA does not encourage it for the general public. Avanti's manufacturer, London International U.S. Holding Inc., is conducting an efficacy trial that will provide the first data on protection against pregnancy and sexually transmitted diseases. PMID:11362323

  1. A Sliding Mode Control for Four-Wire Shunt Active Filter

    NASA Astrophysics Data System (ADS)

    Hamoudi, Farid; Chaghi, Aziz; Adli, Mouloud; Amimeur, Hocine

    2011-09-01

    The present paper deals with the sliding mode control of a three-phase four-wire shunt active filter SAF, to improve phase-current waveform, neutral current mitigation and reactive power compensation in electric power distribution system. The sliding mode is formulated using elementary differential geometry, then the control vector is deduced from the sliding surface accessibility using the Lyapunov stability. The algorithm used to establish the current references for the sliding mode controller is based on the instantaneous real and imaginary power theory for four-wire system. It will be seen that this method permits to synthesis the control vector with simple manner, and finally, the obtained simulation results confirm that the above objectives are satisfied.

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

    PubMed Central

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

    2010-01-01

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

  3. Resistance to Sliding on Atomic Scales

    NASA Technical Reports Server (NTRS)

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

    1995-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2012-02-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2007-02-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-02-01

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

  7. A rotation model for microtubule and filament sliding.

    PubMed

    Jarosch, R; Foissner, I

    1982-02-01

    Simple model experiments show that the cyclic motion of myosin cross-bridges in muscle which is assumed to be active ("sliding model" by "power-stroke" or "rowing-stroke" of the crossbridges) can be interpreted equally well as a passive process during which the myosin heads simply lock mechanically into the grooves of the thin filaments. In order to explain the sliding process a filament or microtubule rotation is assumed to be combined with the winding and unwinding of associated helical protein filaments ("MAPs", "dynein"). As shown in further model experiments the direction of helix winding or unwinding along a rod (microtubule) determines the direction of rod displacement ("parallel" or "antiparallel sliding"). The "sidearms" and "bridges" visible in the electron microscope along the cytoskeletal elements might correspond to the winding or unwinding filaments. On the basis of this conception simple models for the behavior of spindle microtubules and the anaphase movement of chromosomes are presented. The latter is assumed to occur via the unwinding of helical filaments accompanying the kinetochore microtubules, which causes their simultaneous depolymerization. PMID:6461555

  8. High velocity sliding at polycrystalline ductile metal interfaces

    NASA Astrophysics Data System (ADS)

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

    2014-03-01

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

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

    NASA Astrophysics Data System (ADS)

    Thomas, M.; Loague, K.

    2013-12-01

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

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

    PubMed

    Ehteshami Bejnordi, Babak; Litjens, Geert; Timofeeva, Nadya; Otte-Holler, Irene; Homeyer, Andre; Karssemeijer, Nico; van der Laak, Jeroen Awm

    2016-02-01

    Variations in the color and intensity of hematoxylin and eosin (H&E) stained histological slides can potentially hamper the effectiveness of quantitative image analysis. This paper presents a fully automated algorithm for standardization of whole-slide histopathological images to reduce the effect of these variations. The proposed algorithm, called whole-slide image color standardizer (WSICS), utilizes color and spatial information to classify the image pixels into different stain components. The chromatic and density distributions for each of the stain components in the hue-saturation-density color model are aligned to match the corresponding distributions from a template whole-slide image (WSI). The performance of the WSICS algorithm was evaluated on two datasets. The first originated from 125 H&E stained WSIs of lymph nodes, sampled from 3 patients, and stained in 5 different laboratories on different days of the week. The second comprised 30 H&E stained WSIs of rat liver sections. The result of qualitative and quantitative evaluations using the first dataset demonstrate that the WSICS algorithm outperforms competing methods in terms of achieving color constancy. The WSICS algorithm consistently yields the smallest standard deviation and coefficient of variation of the normalized median intensity measure. Using the second dataset, we evaluated the impact of our algorithm on the performance of an already published necrosis quantification system. The performance of this system was significantly improved by utilizing the WSICS algorithm. The results of the empirical evaluations collectively demonstrate the potential contribution of the proposed standardization algorithm to improved diagnostic accuracy and consistency in computer-aided diagnosis for histopathology data. PMID:26353368

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

    SciTech Connect

    Hoagland, Richard G.; Kurtz, Richard J.

    2002-04-01

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

  12. 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

  13. Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation.

    PubMed

    1998-05-01

    The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment. PMID:10179326

  14. 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.

  15. NEMD simulations for ductile metal sliding

    SciTech Connect

    Hammerberg, James E; Germann, Timothy C; Ravelo, Ramon J; Holian, Brad L

    2011-01-31

    We have studied the sliding behavior for a 19 M Al(110)/Al(110) defective crystal at 15 GPa as a function of relative sliding velocity. The general features are qualitatively similar to smaller scale (1.4 M) atom simulations for Al(111)/Al(110) nondefective single crystal sliding. The critical velocity, v{sub c}, is approximately the same for the defective crystal as the size scaled v{sub c}. The lower velocity tangential force is depressed relative to the perfect crystal. The critical temperature, T*, is depressed relative to the perfect crystal. These conclusions are consistent with a lower value for f{sub c} for the defective crystal. The detailed features of structural transformation and the high velocity regime remain to be mapped.

  16. Liquid crystal studies of sliding vapour bubbles

    NASA Astrophysics Data System (ADS)

    Kenning, D. B. R.; Bustnes, O.-E.

    2009-05-01

    The paper discusses localized measurements that may be used to validate individual sub-models in mechanistic models of nucleate boiling on inclined surfaces with sliding bubbles. A previous study of wall temperature variations near isolated sliding bubbles by Kenning et al. (Multiphase Sci Technol 14:75-94, 2002), employing liquid crystal thermography, has been expanded in range and compared with recent studies by Qiu and Dhir (Exp Therm Fluid Sci 26:605-616, 2002) and Bayazit et al. (J Heat Transfer 125:503-509, 2003). The implications for modelling nucleate boiling are discussed.

  17. 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

  18. 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

  19. 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

  20. Newly recognized submarine slide complexes in the southern California Bight

    NASA Astrophysics Data System (ADS)

    Conrad, J. E.; Lee, H. J.; Edwards, B. D.; McGann, M.; Sliter, R. W.

    2012-12-01

    New high-resolution bathymetric and seismic-reflection surveys have imaged large (<0.5 km3) submarine landslides offshore southern California that have not been previously recognized in the Borderland. The new data show several large slides or slide complexes that include: 1) a slide complex consisting of numerous (>7) individual overlapping slides along the western margin of Santa Cruz Basin (SCB slide); 2) a series of slumps and slide scars on the slope south of San Pedro shelf (SPS slide); and 3) a slope failure along the shelf edge in northern San Diego County, termed the Del Mar slide. The SCB slide complex extends for 30 km along the western slope of Santa Cruz Basin, with debris lobes extending 5-8 km into the basin. Head scarps of some of these slides are 50-75 m high. The SPS slide complex also appears to consist of multiple slides, which roughly parallel the Palos Verdes Fault and the San Gabriel Canyon submarine channel on the shelf edge and slope south of San Pedro shelf. Slide deposits associated with this complex are only partially mapped due to limited high-resolution bathymetric coverage, but extend to the south in the area SW of Lasuen Knoll. Seismic-reflection profiles show that some of these deposits are up to 20 m thick. The Del Mar slide is located about 10 km north of La Jolla Canyon and extends about 6 km along the shelf edge. The head scarp lies along the trend of a branch of the Rose Canyon Fault Zone. Radiocarbon ages of sediment overlying this slide indicate the Del Mar slide is approximately 12-16 ka. These large slide complexes have several characteristics in common. Nearly all occur in areas of tectonic uplift. All of the complexes show evidence of recurrent slide activity, exhibiting multiple headwall scarps and debris lobes, and where available, high-resolution seismic-reflection profiles of these slide areas provide evidence of older, buried mass transport deposits. Assuming typical sedimentation rates, the recurrence interval of major slide events appears to be on the order of tens of thousands of years. Most of the slide complexes do not appear to be located in areas of high sediment input. The SCB and Del Mar slides are in areas receiving relatively small terrestrial sediment input from fluvial sources, as are most other previously recognized submarine slides in the Borderland. Only the SPS slide, which lies adjacent to the San Gabriel Canyon submarine channel, is associated with a significant fluvial sediment source.

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

    PubMed

    Das, Madhulika; Mahanta, Chitralekha

    2014-07-01

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

  2. Presenting Mitosis

    ERIC Educational Resources Information Center

    Roche, Stephanie; Sterling, Donna R.

    2005-01-01

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

  3. 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…

  4. Introducing Recent NASA Discoveries into the Astro 101 Classroom with Modular Slide Sets

    NASA Astrophysics Data System (ADS)

    Meinke, B.; Schultz, G.; Bianchi, L.; Blair, W. P.; Len, P. M.

    2014-07-01

    This paper summarizes the special interest group discussion about slides sets for use by Astronomy 101 instructors. The NASA Science Mission Directorate Astrophysics Education and Public Outreach Forum is coordinating the development of a pilot series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The “Astro 101 slide sets” are presentations of 5-7 slides on a new development or discovery from a NASA Astrophysics mission relevant to topics in introductory astronomy courses. We intend for these slide sets to help Astronomy 101 instructors include new developments (discoveries not yet in their textbooks) into the broader context of the course. With their modular design and non-technical language, the slide sets may also serve audiences beyond Astronomy 101 instruction and are adaptable to different needs. An example on exoplanets was highlighted in this session. In this paper, we outline the community feedback, which falls into the broad categories of content, format, uses, relevant topics, and future adaptations.

  5. Universal fuzzy integral sliding-mode controllers for stochastic nonlinear systems.

    PubMed

    Gao, Qing; Liu, Lu; Feng, Gang; Wang, Yong

    2014-12-01

    In this paper, the universal integral sliding-mode controller problem for the general stochastic nonlinear systems modeled by Itô type stochastic differential equations is investigated. One of the main contributions is that a novel dynamic integral sliding mode control (DISMC) scheme is developed for stochastic nonlinear systems based on their stochastic T-S fuzzy approximation models. The key advantage of the proposed DISMC scheme is that two very restrictive assumptions in most existing ISMC approaches to stochastic fuzzy systems have been removed. Based on the stochastic Lyapunov theory, it is shown that the closed-loop control system trajectories are kept on the integral sliding surface almost surely since the initial time, and moreover, the stochastic stability of the sliding motion can be guaranteed in terms of linear matrix inequalities. Another main contribution is that the results of universal fuzzy integral sliding-mode controllers for two classes of stochastic nonlinear systems, along with constructive procedures to obtain the universal fuzzy integral sliding-mode controllers, are provided, respectively. Simulation results from an inverted pendulum example are presented to illustrate the advantages and effectiveness of the proposed approaches. PMID:24718584

  6. 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…

  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. An Adaptive Supervisory Sliding Fuzzy Cerebellar Model Articulation Controller for Sensorless Vector-Controlled Induction Motor Drive Systems

    PubMed Central

    Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

    2015-01-01

    This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes—the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC—were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes. PMID:25815450

  9. An adaptive supervisory sliding fuzzy cerebellar model articulation controller for sensorless vector-controlled induction motor drive systems.

    PubMed

    Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

    2015-01-01

    This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes--the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC--were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes. PMID:25815450

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

    PubMed

    Collins, Jannette

    2004-01-01

    Most radiologists are now creating their own image and text slides for oral presentations. PowerPoint software offers a tremendous number of options for personalizing slides. Having choices of font, color scheme, display options, sound, and graphics provide an opportunity to enhance a presentation in ways that were not possible with 35-mm slides and slide projectors. However, inappropriate use of PowerPoint features can substantially degrade the quality of a presentation. Many of the "rules" for creating an effective presentation given with slide projectors apply to electronic presentations, but some of the options available with only electronic presentations (eg, building, transitioning, and sound) necessitate new "rules." The article provides tips on how to develop effective text and image slides for electronic presentation by using PowerPoint, including the appropriate use of text, font, color, sound, graphics, slide display, and radiologic images. PMID:15256637

  11. Creating a Slide-Tape Show.

    ERIC Educational Resources Information Center

    Kert, Isabel

    1980-01-01

    The opportunities for real language use in creating a slide show in the language class are described. Fifteen steps for replicating the project are included. Students choose the topic, develop the story line, create the dialogue, take the photographs, write the script, and act the roles. (PMJ)

  12. Enhancing Creative Thinking through Designing Electronic Slides

    ERIC Educational Resources Information Center

    Mokaram, Al-Ali Khaled; Al-Shabatat, Ahmad Mohammad; Fong, Fook Soon; Abdallah, Andaleeb Ahmad

    2011-01-01

    During the shifting of teaching and learning methods using computer technologies, much emphasis was paid on the knowledge content more than the thinking skills. Thus, this study investigated the effects of a computer application, namely, designing electronic slides on the development of creative thinking skills of a sample of undergraduate…

  13. Sliding, Insulating Window Panel Reduces Heat Loss.

    ERIC Educational Resources Information Center

    School Business Affairs, 1984

    1984-01-01

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

  14. Ceramic wear in indentation and sliding

    NASA Technical Reports Server (NTRS)

    Miyoshi, K.; Buckley, D. H.

    1984-01-01

    The various wear mechanisms involved with single-crystal ceramic materials in indentation and in sliding contacts. Experiments simulating interfacial events have been conducted with hemispherical, conical and pyramidal indenters (riders). With spherical riders, under either abrasive or adhesive conditions, two types of fracture pits have been observed. First, spherical-shaped fracture pits and wear particles are found as a result of either indenting or sliding. These are shown to be due to a spherical-shaped fracture along the circular or spherical stress trajectories. Second, polyhedral fracture pits and debris, produced by anisotropic fracture, and also found both during indenting and sliding. These are primarily controlled by surface and subsurface cracking along cleavage planes. Several quantitative results have also been obtained from this work. For example, using a pyramidal diamond, crack length of Mn-Zn ferrite in the indentation process grows linearly with increasing normal load. Moreover, the critical load to fracture both in indentation and sliding is essentially isotropic and is found to be directly proportional to the indenter radius.

  15. Sliding between incommensurate interfaces in two dimensions

    NASA Astrophysics Data System (ADS)

    Hammerberg, J. E.; Röder, J.; Germann, T. C.

    2001-03-01

    Consider taking two slabs of identical close-packed material and orienting one at 90^o to the other. This produces an incommensurate interface between the two workpieces, with the average atomic separation at one interface being √3 larger than that in the other. Large scale molecular dynamics (MD) simulations of the unlubricated sliding between two such two-dimensional workpieces reveal an interesting, non-monotonic frictional force as a function of sliding velocity. A study of the atomistic motions shows that, at low velocities, the main contribution to the frictional force results from the dynamics of three atomic layers at the interface. We have developed a model to describe this behavior and have used it to evaluate the low velocity frictional properties. Our model explains the linear dependence of the frictional force on sliding velocity at low velocities, as well as predicting corrections to linear behavior and their dependence on material properties. We compare our model predictions quantitatively with the MD data and also estimate the sliding velocity below which we expect our model to yield valid results. We discuss the atomistic mechanism which comes into play at higher velocities, producing the change in frictional behavior seen in the MD simulations.

  16. Particle Sliding on a Rough Incline

    ERIC Educational Resources Information Center

    Zurcher, Ulrich

    2007-01-01

    We study a particle sliding on a rough inclined plane as an example of a mechanical problem with nonholonomic constraint. The particle is launched in an arbitrary direction so that its motion has both a horizontal and a "vertical" (i.e., up- and downhill) direction. The friction force acts along the instantaneous velocity, so that the horizontal…

  17. Particle Sliding on a Rough Incline

    ERIC Educational Resources Information Center

    Zurcher, Ulrich

    2007-01-01

    We study a particle sliding on a rough inclined plane as an example of a mechanical problem with nonholonomic constraint. The particle is launched in an arbitrary direction so that its motion has both a horizontal and a "vertical" (i.e., up- and downhill) direction. The friction force acts along the instantaneous velocity, so that the horizontal

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

    ERIC Educational Resources Information Center

    Kiss, Marilyn

    1989-01-01

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

  19. Solenoid valve design minimizes vibration and sliding wear problem

    NASA Technical Reports Server (NTRS)

    Gillon, W. A., Jr.

    1968-01-01

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

  20. How to Prepare Clay-Lift and Sandwich Slides.

    ERIC Educational Resources Information Center

    Barman, Charles R.

    1984-01-01

    Describes two techniques for making 35 millimeter slides without using photographic film. One method uses clear adhesive contact paper and the other uses transparency film. Both techniques are inexpensive and require only a few minutes of preparation per slide. (JM)

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... section, if the article of food is arriving by international mail, you must submit the prior notice before... GENERAL ENFORCEMENT REGULATIONS Prior Notice of Imported Food Requirements to Submit Prior Notice of...) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  2. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... section, if the article of food is arriving by international mail, you must submit the prior notice before... GENERAL ENFORCEMENT REGULATIONS Prior Notice of Imported Food Requirements to Submit Prior Notice of...) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  3. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... section, if the article of food is arriving by international mail, you must submit the prior notice before... GENERAL ENFORCEMENT REGULATIONS Prior Notice of Imported Food Requirements to Submit Prior Notice of...) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  4. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... section, if the article of food is arriving by international mail, you must submit the prior notice before... GENERAL ENFORCEMENT REGULATIONS Prior Notice of Imported Food Requirements to Submit Prior Notice of...) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  5. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... section, if the article of food is arriving by international mail, you must submit the prior notice before... GENERAL ENFORCEMENT REGULATIONS Prior Notice of Imported Food Requirements to Submit Prior Notice of...) of this section, you must submit the prior notice to FDA and the prior notice submission must...

  6. 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... Regulated Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for... Transparency to Regulated Industry.'' The report includes 19 action items and 5 draft proposals to...

  7. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  8. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  11. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Cancer.gov

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... request for continued use of an assigned labeler code must be submitted by email to: udi@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food... address, email address, and phone number of the labeler who is currently using the labeler code; (2)...

  14. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  16. 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)

  17. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of...

  18. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  2. 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

    ... Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm... Evaluation and Research, and Center for Devices and Radiological Health). This guidance also responds to... on the circumstances under which FDA should consider public release of financial...

  3. 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

  4. 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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... on this topic in March 2010 (75 FR 11893, March 12, 2010) and draft proposals from this phase are... recommendations. Over the last 11 months, the Task Force has held two public meetings, launched an online blog ( http://fdatransparencyblog.fda.gov/ ), and opened a docket. The online blog and the docket...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Formal Meetings Between FDA... biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the...

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

    PubMed

    Deyo, Richard A

    2004-01-01

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

  8. 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...

  9. 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 informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  12. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  13. 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 informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human...

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

    MedlinePlus

    ... gov/downloads/Food/ComplianceEnforcement/UCM073281.pdf How will water contaminated with radioactive materials affect seafood safety? FDA ... swim from the reactor site into U.S. fishing waters? Japan to U.S. waters would take several days ...

  15. 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...

  16. FDA 101: How to Use the Consumer Complaint System and MedWatch

    MedlinePlus

    ... the Consumer Complaint System and MedWatch Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Get Consumer Updates by ... is important and is recorded in an FDA database for review and comparison to similar previous reports. ...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false How does FDA define important terms in this part? 1271.3 Section 1271.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES, AND CELLULAR AND...

  18. 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... off in a box or similar enclosure by the use of a barline with all black type printed on a white... Facts” box (or similar enclosure), providing separation between each of the headings. 2. A...

  19. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Examples of Graphic Enhancements Used by FDA A... off in a box or similar enclosure by the use of a barline with all black type printed on a white... Facts” box (or similar enclosure), providing separation between each of the headings. 2. A...

  20. 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... off in a box or similar enclosure by the use of a barline with all black type printed on a white... Facts” box (or similar enclosure), providing separation between each of the headings. 2. A...