Sample records for fda presentation slides

  1. iPhone Programming Presentation: Slides

    NSDL National Science Digital Library

    Qaissaunee, Michael

    These are the slides from an iPhone programming presentation given by Mike Qaissaunee for the Brookdale Community College Computer Science Club. The video of the presentation and the narration of these slides are also available.

  2. Past, Present & Future: FDA regulation of combination products and

    Microsoft Academic Search

    Leah R. Kendall

    2 The warning letter arose out of an inspection of a medical device manufacturer by FDA's Los Angeles District. During the inspection, FDA also inspected certain corporate entities of the manufacturer that made drug-device combination products. The manufacturer asserted that these drug-device combination products were subject to regulation only under the device GMPs. FDA disagreed and referred the manufacturer to

  3. Insert presenter logo here on slide master.

    E-print Network

    Gutmann, Peter

    University of Auckland PKI: Lemon Markets and Lemonade Session ID: STAR-304 Session Classification: Intermediate Insert presenter logo here on slide master. See hidden slide 2 for directions Agenda 2 Lemon master. See hidden slide 2 for directions3 Lemon Markets / PKI Markets Insert presenter logo here

  4. SSP: Sketching Slide Presentations, a Syntactic Approach

    NASA Astrophysics Data System (ADS)

    Mas, Joan; Sanchez, Gemma; Lladós, Josep

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

  5. iPhone Programming Presentation - Slides with Narration

    NSDL National Science Digital Library

    Qaissaunee, Mike

    This is a video including slides with narration from an iPhone programming presentation given by Mike Qaissaunee for the Brookdale Community College Computer Science Club. The video of the presentation and the slides are also available.

  6. Conceptual Framework Presentation, 2006, Slide 1 The Conceptual Framework for

    E-print Network

    de Lijser, Peter

    ... · Consists of several elements that include ­A vision statement ­A mission statement ­An underlying Framework Presentation, 2006, Slide 10 Our Vision Statement We envision our community, taken in its broadest. #12;Conceptual Framework Presentation, 2006, Slide 11 Our Mission Statement Our mission is to teach

  7. FDA Centennial

    NSDL National Science Digital Library

    2006-01-01

    On June 30th 1906, President Theodore Roosevelt signed the Food and Drugs Act, which prohibiting interstate commerce in misbranded and adulterated foods, drinks, and drugs. Broadly understood, this action was part of the Progressive Movement in the United States which brought forth a number of substantial changes in the way that government interacted with private industry and so on. 100 years on, the Food and Drug Administration (FDA) has decided to celebrate the centennial of this act by creating this site. Starting at the homepage, visitors can learn about events created to celebrate the FDA's legacy as well as read a nice feature titled "This Week in FDA History". Visitors may also want to look through a nice graphic presentation titled "FDA's Role in Protecting and Promoting Public Health". Through images and text, this presentation brings together some highlights of their work over the years, including information about the effects of the Federal Food, Drug, and Cosmetic Act of 1938. Finally, the site also contains a short quiz on FDA history.

  8. The Patient Advocate Perspective on Preparing for FDA Advisory Committee Presentations

    Microsoft Academic Search

    Abbey S. Meyers

    2000-01-01

    This article highlights the author's experiences as a patient advocate serving on the Food and Drug Administration (FDA) Biological Response Modifiers Committee. It provides an overview of the National Organization for Rare Disorders and the scope of the orphan disease problem. The author explains the process of serving on an advisory committee, and highlights the important role of patient advocates

  9. FDA Almanac

    NSDL National Science Digital Library

    United States. Food and Drug Administration.

    1999-01-01

    The Office of Public Affairs for the Food and Drug Administration, the Public Health Service, and the Department of Health & Human Services has placed the most recent FDA Almanac online. The Almanac serves as a comprehensive starting point for information on the FDA and its subsidiary agencies. The introduction offers an overview of the FDA's organization, its mission, and its vision for the year 2000, as well as a compilation of the major laws it enforces. The Almanac itself contains information on the agency's 1999 budget and links to its major departments, such as the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs. Additional resources include a list of milestones in US food and drug law history, FDA-related acronyms and abbreviations, and a guide to obtaining information from the FDA.

  10. Slide presentation Architectures for Emotional Animals and Machines

    E-print Network

    Sloman, Aaron

    ? How does this relate to alternative theories? Have we accounted for everything (including qualia?). Unsolved problems: where next? IK2002 / BBC02 Slide 2 Architectures for Emotions #12;"Advertisement" I use only LINUX/UNIX SYSTEMS AND FREE SOFTWARE Including: Latex, dvips, ps2pdf Diagrams are created using

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

    NASA Astrophysics Data System (ADS)

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

    2014-12-01

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

  12. FDA Terminology

    Cancer.gov

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

  13. 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…

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

    NASA Technical Reports Server (NTRS)

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

    1990-01-01

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

  15. Pilot testing of a new design for presentation slides to teach science and engineering

    Microsoft Academic Search

    Michael Alley; Madeline Schreiber; John Muffo

    2005-01-01

    Pilot testing in a large geology course shows that a new sentence-headline design of presentation slides was more effective than the traditional phrase-headline design at teaching science to undergraduates. Rather than having a phrase headline supported by a bullet list, the new design relies on a succinct sentence headline supported by visual evidence. In the new design, bullets are not

  16. FDA Kids' Home Page

    MedlinePLUS

    ... Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page:

  17. Drugs@FDA: FDA Approved Drug Products

    MedlinePLUS

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

  18. FDA Authority Over Cosmetics

    MedlinePLUS

    ... cosmetics manufacturers? FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine ... consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP ...

  19. FDA Certified Mammography Facilities

    MedlinePLUS

    ... Phone 50 Fax 50 Facilities must contact their accreditation body to update or correct their address or ... on information received from the four FDA-approved accreditation bodies: the American College of Radiology (ACR), and ...

  20. FROM LANTERN SLIDES TO IMAGE PRESENTATION SYSTEMS: A DISCIPLINE IN TRANSITION

    Microsoft Academic Search

    Eileen Fry

    ew corporate announcements have had the effect on entire academic disciplines that Eastman Kodak's 2003 decision to stop manufacturing slide projectors had on Art History. The known world of side- by-side slide projection, large luminous images, well- organized institutional collections, last-minute lecture preparation, excellent commercial suppliers, and easy in-house production to support even the most special- ized of topics seemed

  1. Beyond biotechnology: FDA regulation of nanomedicine.

    PubMed

    Miller, John

    2003-01-01

    Nanotechnology, which involves investigating and manipulating matter at the atomic and molecular levels, may radically transform industry and society. Because nanotechnology could introduce whole new classes of materials and products, it could present an array of novel challenges to regulatory agencies. In this note, John Miller explores the regulatory challenges facing the Food and Drug Administration in regulating nanomedical products. First, the FDA will have trouble fitting the products into the agency's classification scheme. Second, it will be difficult for the FDA to maintain adequate scientific expertise in the field. He concludes that the FDA should consider implementing several reforms now to ensure that it is adequately prepared to regulate nanomedicine. PMID:15977335

  2. FDA 101: Regulating Biological Products

    MedlinePLUS

    ... mail Consumer Updates RSS Feed FDA 101: Regulating Biological Products Search the Consumer Updates Section Consumer Update ... friendly PDF (196 KB) On this page: What biological products does FDA regulate? How do biologics differ ...

  3. FDA Kids Homepage

    NSDL National Science Digital Library

    Center for Food Safety and Applied Nutrition (U.S.).

    1998-01-01

    Highlight of the recently opened US Food and Drug Administration's Kids Homepage is Yorick, FDA's "favorite skeleton," which allows users to see the various medical devices and implants that can replace real body parts. Included are such items as a glass eye, a silicon cochlear implant, a hip and a knee, among others. In addition, there is a kids quiz on food safety, a medicine cabinet word find (unfortunately not interactive), a tobacco quiz, information about vaccines, and a food safety coloring book, among other features. Information is aimed mostly at young children, but Yorick should also be of interest to older users.

  4. Electric Slide

    NSDL National Science Digital Library

    2013-07-11

    To some the electric slide may just be a novelty dance. Astute readers of technology blogs will know that this Electric Slide happens to be a application that allows visitors to wirelessly present their PowerPoint slides, documents, and videos using just their iPhone or iPad. First-time visitors can watch an instructional video and then go ahead and get started. The Features area contains details on the operations of the program and the Help section offers up some useful suggestions. This version is compatible with all operating systems running iOS 5.1.1 and newer.

  5. FDA: CVaccines, Blood & Biologics

    NSDL National Science Digital Library

    The mission of the Food and Drug Administration's (FDA) Vaccines, Blood & Biologics program is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies." Their mission is an important one, and consumers and scientists will want to bookmark this page and return to it on a regular basis. On the right-hand side of the page, visitors can sign up for their RSS feed, check out the "About" section, and read through their FAQ. In the center of the page, visitors can peruse the "Hot Topics", which at any given moment might include information on influenza vaccinations or product recalls or withdrawals. The site is rounded out by topical guide to the site along the left-hand side of the homepage.

  6. Bayesian Statistics in Medical Devices: Innovation Sparked by the FDA

    Microsoft Academic Search

    Gregory Campbell

    2011-01-01

    Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials

  7. How FDA Evaluates Regulated Products: Cosmetics

    MedlinePLUS

    ... products and safety data. Inspections : FDA can inspect manufacturing facilities to determine if proper controls and practices ... lead in lipstick? Does FDA approve the color additives used in cosmetics? If so, how does FDA ...

  8. FDA Cuts Trans Fat in Processed Foods

    MedlinePLUS

    ... Department of Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health ... Consumer Updates FDA Cuts Trans Fat in Processed Foods Search the Consumer Updates Section Download this FDA ...

  9. FDA'S Inspections of Clinical Investigators

    Microsoft Academic Search

    Michael Bruckheimer

    1993-01-01

    The FDA's recently revised compliance program for inspections of clinical investigators now focuses on determining authority to control the clinical studies and responsibility for administration of every aspect of the trial. During these inspections, we compare raw data with case record forms and in the converse, case record forms with raw data. We look for drug accountability; adherence by the

  10. FDA's perspectives on cardiovascular devices.

    PubMed

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

    2009-06-01

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

  11. Human factors and the FDA's goals: improved medical device design.

    PubMed

    Burlington, D B

    1996-01-01

    The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here. PMID:8673158

  12. Your Guide to Reporting Problems to FDA

    MedlinePLUS

    ... and other biologics (except vaccines), dietary supplements, infant formulas and medical foods such as nutritional supplements. Report ... problems Pet Food Reporting Portal FDA's Center for Veterinary Medicine at 1-888-FDA-VETS (1-888- ...

  13. Slide Tutorials Slide Tutorials

    E-print Network

    to provide guidelines for identification of individual silt- and clay-sized components in smear slides observed, namely the proportions of clay-sized (4 µm), silt-sized (4- to 63-µm), and sand-sized (63- to 2 be estimated using comparator charts (e.g., Mazzullo and Graham, 1988). Note that many of the silt

  14. Earthquake Damage Slide Show

    NSDL National Science Digital Library

    This slide show presents examples of various types of damage caused by earthquakes. Photos include structural failures in bridges and buildings, landshifts, landslides, liquefaction, fires, tsunamis, and human impacts. Supplemental notes are provided to aid instructors about the photos presented on each slide.

  15. 2013 FDA FOOD CODE FDA/CFSAN Retail Food Protection Team

    E-print Network

    Jawitz, James W.

    2013 FDA FOOD CODE FDA/CFSAN Retail Food Protection Team #12;The FDA Food Code: · Provides FDA's current thinking on food safety, sanitation, and fair dealing in the retail food sector · Can be uniformly adopted as a statute, regulation or ordinance for the retail, food service and vending segment of the food

  16. The sawtooth cover slide

    NASA Technical Reports Server (NTRS)

    Meulenberg, A., Jr.

    1977-01-01

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

  17. Slide 1

    Cancer.gov

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

  18. Doctors, drugs, and the FDA.

    PubMed

    Shanklin, D R

    1972-11-01

    This communication is directed to obstetricians, to the Food and Drug Administration (FDA), and to those individuals who might want to impose possibly unnecessary external structures on the practice of medicine. It is considered a positive that the patients of today are well informed and are more actively participating in therapeutic design. There is more veto power on the part of the patient and more concern over the trained ability of the physician. In the past physicians frequently made judgements individually, applying isolated and at times random standards for their decisions. Such actions were inevitable in an era when neither pathogenesis nor treatment was well understood. Now there is no excuse for such actions. Communication is easy, journals are widely circulated, and there are numerous refresher seminars. Increased specialization of knowledge has meant more corporate or group decisions for therapy. Current trends will continue to offer both opportunities and responsibilities. The opportunities are for better diffusion of knowledge, and the responsibility is to be informed. There can be a high level national standard for medical practice. As a beginning, the medical practice laws could use some uniform decisions. The FDA needs to show more responsiveness to changing knowledge and increased willingness to reconsider indications and contraindications in the light of newer experience. There is sufficient information available now to support the revocation of the approval of the use of diuretics in the management of human pregnancy. Another role of the FDA is the approval of new substances or new uses of old substances. The prostaglandins appear in this category, and the December 1972 issue will include the recent Brook Lodge Symposium on prostaglandins. The individual physician requires journal articles, individual experience, and designed trials in order to make judgements on patients who may have some factors not accounted for by groupthink or regulations. PMID:4634511

  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. 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

    ...Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee...and FDA Staff: Public Availability of Advisory...The Food and Drug Administration (FDA) is announcing...a guidance for the public, FDA advisory...

  1. The Implementation of FDA Determinations in Litigation - Why Do We Defer to the PTO but Not to the FDA?

    Microsoft Academic Search

    William G. Childs

    2004-01-01

    This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the

  2. Paleoclimatology Slides

    NSDL National Science Digital Library

    2001-10-12

    These slide sets have been produced by the National Oceanic and Atmospheric Administration (NOAA) to illustrate some of the concepts and methods involved in paleoclimate research. Each set of 20-40 slides includes vivid photographs of field research conducted around the globe, high-quality graphics of important datasets, and descriptive diagrams, making these sets ideal instructional aides. The slide sets can be purchased as 35 mm slides or viewed online. The online version includes a glossary, detailed background information and large, high-resolution versions of each slide. Included is a detailed narrative that is designed to accompany the slides. Topics include the ice ages, climate and the classic Maya civilization, coral paleoclimatology, polar ice cores, pack rat middens, tree rings, Heinrich events, and low latitude ice cores.

  3. Guidance for Industry and FDA Staff

    E-print Network

    . This is based on ongoing experience in the field and numerous literature reviews.1,2 FDA's guidance documents from the Internet at: http://www.fda.gov/cdrh/ode/guidance/793.pdf or to receive this document by fax device regulation. This guidance reflects our careful review of the relevant scientific and legal

  4. FDA: Between Process and Product Evaluation

    Microsoft Academic Search

    Marwan M. Abdeen; Wolfram Kahl; Tom Maibaum

    2007-01-01

    Several institutions and agencies around the world, from both the private and public sectors, have adopted the practice of software validation and certification to ensure higher levels of confidence in software. The US Food and Drug Administration (FDA) is one of these organisations. The FDA has published several guidance documents concerning the validation of medical device software. In its guidance

  5. 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…

  6. Slide system for machine tools

    DOEpatents

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

    1982-01-01

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

  7. Slide system for machine tools

    DOEpatents

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

    1980-06-12

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

  8. Opportunities at FDA: Bench Science and Regulatory Review of Science

    NSDL National Science Digital Library

    PhD Kevin J Greenlees (Food and Drug Administration)

    2010-04-25

    This recorded presentation on "Physiologists and the FDA" is part of the EB 2010 Careers Symposium - Government Careers in Physiology Revealed. The target audience is students and postdoctoral fellows, as well as early career and established investigators seeking information on job opportunities and career development processes in the government.

  9. Opportunities at FDA: Bench Science and Regulatory Review of Science

    NSDL National Science Digital Library

    PhD Kevin J Greenlees (Food and Drug Administration)

    2010-04-25

    This powerpoint presentation file on "Physiologists and the FDA" is part of the EB 2010 Careers Symposium - Government Careers in Physiology Revealed. The target audience is students and postdoctoral fellows, as well as early career and established investigators seeking information on job opportunities and career development processes in the government.

  10. New Antibiotic Approved by FDA

    NSDL National Science Digital Library

    Ramanujan, Krishna.

    Last week, the FDA approved Zyvox (known generically as linezolid), the first in a new class of synthetic antibacterial drugs -- called oxazolidinones -- designed to treat a number of drug-resistant infections. Zyvox has proven effective in treatment of infections associated with vancomycin-resistant Enterococcus faecium (VREF) as well as hospital-acquired pneumonia and complicated skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). This is the first drug to be approved in over 40 years for fighting hospital-acquired infections that are resistant to antibiotics. "It comes at a time when we were literally running out of antibiotics," said Dr. Robert C. Moellering Jr., physician-in-chief of Boston's Beth Israel-Deaconness Hospital, in a recent AP news article. In an attempt to preserve the long-term effectiveness of Zyvox and discourage microbes from developing renewed resistance, some doctors are calling for cautious use of the drug for only the worst antibiotic-resistant infections. This week's In The News takes a look at this new development and its consequences for antibiotic resistant bacteria.

  11. Slide 1

    Cancer.gov

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

  12. Scam Alert: Beware of Bogus FDA Agents

    MedlinePLUS

    ... this page Home For Consumers Consumer Updates Scam Alert: Beware of Bogus FDA Agents Search the Consumer ... or via telephone, you may also want to alert your credit card company and make sure that ...

  13. FDA Approves First Therapeutic Cancer Vaccine

    Cancer.gov

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

  14. 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 ...

  15. FDA regulatory requirements for medical devices with control algorithms

    Microsoft Academic Search

    A. Ciarkowski

    2000-01-01

    Discusses how the US Food and Drug Administration (FDA) regulates medical devices that include an automatic control system. First, the context of FDA regulation is given. It is indicated how the FDA regulates control systems, so that a device developer may develop an idea of when the device is subject to FDA regulation, what steps he can follow to comply

  16. Archive: FDA/NSTA Symposium: Food Safety and Nutrition, St. Louis, MO: March 31, 2007

    NSDL National Science Digital Library

    FDA

    1900-01-01

    During this half-day symposium, scientists and education specialists from the FDA shared information with teachers about food science, bioscience, and the food label. The presenters also performed activities that enhanced the participants' knowledge about

  17. 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.

  18. Epidural steroid warning controversy still dogging FDA.

    PubMed

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

    2014-01-01

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

  19. 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

  20. US drug regulation: Congress finds FDA wanting.

    PubMed

    Budiansky, Stephen

    1982-08-12

    Food and Drug Administration (FDA) internal documents released this month by a House subcommittee allege that Eli Lilly and Company, which recently suspended sales of the anti-arthritis drug benoxaprofen, has repeatedly failed to report adverse effects of drugs it was testing or marketing. Charges against the company include incomplete and delayed reporting of data, improper record maintenance, and failure to follow clinical protocols. The FDA memoranda mention the possibility of prosecution. An Eli Lilly statement at the subcommittee hearings denied the allegations. PMID:11643777

  1. Quality mammography standards--FDA. Final rule.

    PubMed

    1997-10-28

    The Food and Drug Administration (FDA) is amending its regulations governing mammography. Amendments are being made to the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment and practices, including quality assurance. This action is being taken to provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. It also carries out the intent of Congress that FDA replace the existing interim rules with more comprehensive final regulations. PMID:10177306

  2. Apr. 2012 Cryptography Slide 1 Cryptography

    E-print Network

    Liebling, Michael

    Apr. 2012 Cryptography Slide 1 Cryptography A Lecture in CE Freshman Seminar Series: Ten Puzzling Problems in Computer Engineering #12;Apr. 2012 Cryptography Slide 2 About This Presentation Apr. 2012 #12;Apr. 2012 Cryptography Slide 3 Puzzles and Cryptograms in Archeology #12;Apr. 2012

  3. Food and Drug Administration (FDA) History

    NSDL National Science Digital Library

    On this site, visitors can learn about the origins and history of the U.S. Food and Drug Administration. The navigation menu on the left will help move around the site to areas including FDA's Origin & Functions, Milestones, Leaders and Their Deputies, and Oral Histories. There is also a page of links to other related resources elsewhere online.

  4. FDA and CPMP Rulings on Subgroup Analyses

    Microsoft Academic Search

    Aldo P. Maggioni; Bernadette Darne; Dan Atar; Eric Abadie; Bertram Pitt; Faiez Zannad

    2007-01-01

    The extent to which subgroup analyses should affect the interpretation and conclusions in a trial report is a contentious matter, and guidelines regarding this issue have been established by the US Food and Drug Administration (FDA) and the EU Committee for Proprietary Medicinal Products (CPMP). ubgroup analyses should be set out in the protocol of clinical trials. The treatment effect

  5. Online FDA Regulations: Implications for Medical Writers

    Microsoft Academic Search

    Rita C. Tomlin

    2008-01-01

    Availability of online Food and Drug Administration (FDA) regulations is contributing to a shift in medical writers' organizational role from a peripheral to a central role where their responsibilities for the persuasiveness of documents and compliance with evolving regulations have increased dramatically. Therefore, curricula for medical writers should include instruction in persuasion, collaboration, strategic and project management, the drug development

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

    PubMed

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

    2014-06-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

  9. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions....

  12. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions....

  13. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions....

  14. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions....

  15. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions....

  16. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...2012-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

  17. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...2013-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

  18. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...2011-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

  19. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

  20. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

  1. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...86 Focused FDA regulatory research. At the discretion of the...undertake focused regulatory research on critical rate-limiting...chemical/manufacturing, and clinical phases of drug development...initiated, FDA will undertake such research efforts as a means for...

  2. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...86 Focused FDA regulatory research. At the discretion of the...undertake focused regulatory research on critical rate-limiting...chemical/manufacturing, and clinical phases of drug development...initiated, FDA will undertake such research efforts as a means for...

  3. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...86 Focused FDA regulatory research. At the discretion of the...undertake focused regulatory research on critical rate-limiting...chemical/manufacturing, and clinical phases of drug development...initiated, FDA will undertake such research efforts as a means for...

  4. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...86 Focused FDA regulatory research. At the discretion of the...undertake focused regulatory research on critical rate-limiting...chemical/manufacturing, and clinical phases of drug development...initiated, FDA will undertake such research efforts as a means for...

  5. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...86 Focused FDA regulatory research. At the discretion of the...undertake focused regulatory research on critical rate-limiting...chemical/manufacturing, and clinical phases of drug development...initiated, FDA will undertake such research efforts as a means for...

  6. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...Drugs 5 2010-04-01 2010-04-01 false FDA recognition of exclusive approval. 316.34 Section 316.34 Food...DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send...

  7. 21 CFR 316.34 - FDA recognition of exclusive approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...Drugs 5 2011-04-01 2011-04-01 false FDA recognition of exclusive approval. 316.34 Section 316.34 Food...DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition of exclusive approval. (a) FDA will send...

  8. Mining FDA drug labels for medical conditions

    PubMed Central

    2013-01-01

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

  9. Sources of drug information: FDA-approved labeling and other official FDA sources.

    PubMed

    Lindstrom, Jill A

    2009-01-01

    To protect the public health and facilitate the safe and effective use of prescription drugs, the Food and Drug Administration (FDA) disseminates information through drug labeling, communication of safety issues, and the archiving of scientific reviews. The content and format requirements for professional labeling were revised in 2006 to improve the accessibility and usability of the information. New or emerging safety information is communicated using the formats of public health advisories (PHAs), information for heath care professional sheets, and early communications about ongoing safety reviews. The FDA analyses of approved drug marketing applications and Advisory Committee transcripts are posted on the FDA Web site. Prescribers can utilize these resources to inform the care that they provide to patients. PMID:19453349

  10. RU 486, the FDA and free enterprise.

    PubMed

    Buc, N L

    1992-01-01

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

  11. FDA: Center for Biologics Evaluation and Research

    NSDL National Science Digital Library

    The mission of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies." Their mission is an important one, and consumers and scientists will want to bookmark this page and return to it on a regular basis. On this page, visitors can sign up for their RSS feed and read through some key resources. Users can also browse resources on biologics depending on their needs: consumer, healthcare and industry level information is provided.

  12. Catalog of FDA Approved Drug Products

    NSDL National Science Digital Library

    The Catalog of FDA Approved Drug Products provides information on drugs approved and tentatively approved prescription, over-the-counter, and discontinued drugs. The catalog allows users to browse by drug name, quick search by drug name or active ingredient, or use their advanced search page to look up the drug they are seeking. The catalog is part of the Center fro Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration. This site would be useful for student research as well as for instructors in their classrooms and curricula.

  13. Archive: FDA/NSTA Symposium: Teach Science Concepts and Inquiry with Food, Denver, CO: Nov 9, 2007

    NSDL National Science Digital Library

    FDA

    1900-01-01

    During this half-day symposium, scientists and education specialists from the FDA talked to teachers about food science, food science related careers, and the food label. The presenters also performed activities that enhanced the participants' knowledge a

  14. Archive: FDA/NSTA Symposium: Teach Science Concepts and Inquiry with Food, Boston, MA: March 28, 2008

    NSDL National Science Digital Library

    1900-01-01

    During this half-day symposium, scientists and education specialists from the FDA shared information with teachers about food science, bioscience, and the food label. The presenters also performed activities that enhanced the participants' knowledge about

  15. New FDA guidance on electronic records and signatures.

    PubMed

    Donawa, M

    2001-11-01

    The United States Food and Drug Administration (FDA) is in the process of developing and issuing a series of guidance documents on electronic records and signatures requirements. This article discusses two recently published FDA guidance documents: validation requirements for electronic records and signatures and a glossary of terms. It also highlights the need for industry to provide comments on these documents to FDA. PMID:12938536

  16. FDA-approved small-molecule kinase inhibitors.

    PubMed

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

    2015-07-01

    Kinases have emerged as one of the most intensively pursued targets in current pharmacological research, especially for cancer, due to their critical roles in cellular signaling. To date, the US FDA has approved 28 small-molecule kinase inhibitors, half of which were approved in the past 3 years. While the clinical data of these approved molecules are widely presented and structure-activity relationship (SAR) has been reported for individual molecules, an updated review that analyzes all approved molecules and summarizes current achievements and trends in the field has yet to be found. Here we present all approved small-molecule kinase inhibitors with an emphasis on binding mechanism and structural features, summarize current challenges, and discuss future directions in this field. PMID:25975227

  17. FDA Guidance on Prophylactic DNA Vaccines: Analysis and Recommendations

    PubMed Central

    Klinman, Dennis M.; Klaschik, Sven; Tross, Debra; Shirota, Hidekazu; Steinhagen, Folkert

    2009-01-01

    The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development in this field. PMID:19941989

  18. FDA's MSM Blood Donation Policy: Did You Know??

    E-print Network

    Khan, Javed I.

    FDA's MSM Blood Donation Policy: Did You Know?? Permanent ban on any male who has had sex NOT support the FDA's current MSM blood donation policy. The time it takes to test for HIV with the Nucleic, Japan, Italy, Spain, France and Sweden are countries that have all modified their blood donation

  19. Labeling of trans fatty acid content in food, regulations and limits—The FDA view

    Microsoft Academic Search

    Julie Moss

    2006-01-01

    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

  20. FDA drug prescribing warnings: is the black box half empty or half full?

    Microsoft Academic Search

    Anita K. Wagner; K. Arnold Chan; Inna Dashevsky; Marsha A. Raebel; Susan E. Andrade; Jennifer Elston Lafata; Robert L. Davis; Jerry H. Gurwitz; Stephen B. Soumerai; Richard Platt

    2006-01-01

    PURPOSE: Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with

  1. Modeling the Sliding/Falling Ladder Paradox

    ERIC Educational Resources Information Center

    Fox, William P.; Fox, James B.

    2003-01-01

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

  2. Peat slides and rain fall intensities

    NASA Astrophysics Data System (ADS)

    Carroll, Roselyn; Long, Mike

    2010-05-01

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

  3. Sliding vane geometry turbines

    DOEpatents

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

    2014-12-30

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

  4. Automated Slide Staining Machine

    PubMed Central

    Drew, W. Lawrence; Pedersen, Anders N.; Roy, Jacques J.

    1972-01-01

    A machine is described which can perform the Gram stain. Comparison of slides stained by machine versus hand revealed no difference in reproducibility or accuracy. In addition to providing clean, dry, uniformly stained slides, the machine saves 24 sec per slide when compared with a hand staining technique. Images PMID:4110426

  5. 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…

  6. May 2012 Binary Search Slide 1 Binary Search

    E-print Network

    Liebling, Michael

    Problems in Computer Engineering #12;May 2012 Binary Search Slide 2 About This Presentation to measure up to 40 grams #12;May 2012 Binary Search Slide 4 Find the Lighter Counterfeit Coin We have threeMay 2012 Binary Search Slide 1 Binary Search A Lecture in CE Freshman Seminar Series: Ten Puzzling

  7. Force\\/motion control of constrained robots using sliding mode

    Microsoft Academic Search

    Chun-Yi Su; Tin-hi Leung; Qi-Jie Zhou

    1992-01-01

    A sliding mode control algorithm is presented for trajectory tracking of an end-effector on a constrained surface with specified constraint forces by using the theory of variable structure systems. The development of the algorithm is based on a new formulation of the dynamic model and the expansion of sliding surfaces to include the constraint force error. The proposed sliding controller

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

    PubMed

    Serebruany, Victor L

    2014-03-01

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

  9. 21 CFR 830.100 - FDA accreditation of an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100... UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA accreditation of an issuing agency. (a)...

  10. FDA's Report on New Health Care Products Approved in 1999

    NSDL National Science Digital Library

    Released on January 18 by the US Food and Drug Administration (FDA), this report highlights some of the approximately 140 medications and medical devices approved by the FDA last year. The highlighted products are listed by the groups of patients or diseases they are designed to help. The report also discusses FDA approval and application procedures. While neither extensive nor particularly easy to read, the report still contains a useful overview of the most important new drugs and treatments to enter the market in 1999.

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

    PubMed

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

    2015-02-01

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

  12. 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

  13. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...the time prescribed by FDA. (4) There is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained, or informed consent is...

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

    PubMed

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

    2013-11-14

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

  15. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePLUS

    ... Consumers Consumer Updates What FDA Learned About Dark Chocolate and Milk Allergies Search the Consumer Updates Section ... back to top Milk Detected in Individual Dark Chocolate Products Label/Package Statement Total number of dark ...

  16. FDA Approves New Drugs for Irritable Bowel Syndrome

    MedlinePLUS

    ... gov/medlineplus/news/fullstory_152789.html FDA Approves New Drugs for Irritable Bowel Syndrome Both treat diarrhea ... 2015 THURSDAY, May 28, 2015 (HealthDay News) -- Two new drugs for adults with irritable bowel syndrome with ...

  17. FDA Approves Brain Stimulation Device for Parkinson's Disease

    MedlinePLUS

    ... 153053.html FDA Approves Brain Stimulation Device for Parkinson's Disease Brio Neurostimulation System is second such device approved ... implanted into the brain to help people battling Parkinson's disease. The Brio Neurostimulation System is "an implantable deep ...

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

    SciTech Connect

    Not Available

    1981-10-01

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

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

    E-print Network

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

    2007-01-01

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

  20. Developing Orphan Products: FDA and Rare Disease Day

    MedlinePLUS

    ... Feed Developing Orphan Products: FDA and Rare Disease Day Search the Consumer Updates Section Get Consumer Updates ... 2009, as the 2nd annual World Rare Disease Day—an important time for bringing attention to the ...

  1. FDA Research Helps Keep Pets and Humans Safe

    MedlinePLUS

    ... ways FDA can help minimize the incidence of foodborne illness associated with pet foods and treats,” says Renate ... park visits, and medication use. Almost 3,000 animals were tested in veterinary clinics across the country. ...

  2. FDA Tells Food Industry to Stop Using Artificial Trans Fats

    MedlinePLUS

    ... hydrogenated oils are created by pumping hydrogen into vegetable oil to make it more solid, and are used ... microwave popcorn; frozen pizza; margarine and other spreads; vegetable ... partially hydrogenated oils, or petition the FDA to permit specific uses ...

  3. FDA Issues Warning Letters to Four Manufacturers of ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... Search Archive Submit archive search. ... FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol ...

  4. FDA Regulation of Stem Cellâ??Based Products

    NSDL National Science Digital Library

    Donald Fink (U.S. Food and Drug Administration; )

    2009-06-26

    In the United States, clinical trials designed to demonstrate the safety and effectiveness of stem cellâ??based products are regulated by the U.S. Food and Drug Administration (FDA). To ensure that subjects enrolled in a clinical study involving stem cellâ??based products are not exposed to significant and unreasonable risk, the FDA reviews medical and scientific information to determine whether there is sufficient safety assurance to permit initiation of human clinical studies.

  5. 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…

  6. 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

  7. A Case-Study Based Course on "Device Evaluation and FDA Approval"

    NSDL National Science Digital Library

    Cardinal, Kristen

    Preclinical evaluation of new devices and therapies is an integral part of research and development in the medical device industry, and the regulatory process for FDA approval is a major driving force behind much that goes on in a company setting. A large number of graduating biomedical engineers enter this medical device industry or a related environment upon graduation from our institution. Although these engineers are equipped to address many of the technical challenges that will arise, there is currently limited formal training in or exposure to the regulatory process that is required to bring new devices to market. Knowledge of the typical progression through preclinical testing, as well as an understanding of clinical trial guidelines and the FDA regulatory process would allow students to work more effectively and productively in industry or other medically-related positions. Therefore, a course has been designed entitled Device Evaluation and FDA Approval as an upper division elective at our institution. The goal of this course is to expose students to the overall process of FDA approval, including aspects of both preclinical and clinical testing, in order to prepare them to succeed in a regulatory-based environment. This is a case-study based course, where cases range from small in-class examples that facilitate active student engagement in the material, to large cases that span multiple lessons and incorporate out of class assignments and projects. Cases are selected and presented such that students gain insights into the progression and complexities of real-life devices, while learning in vitro and in vivo preclinical evaluation techniques, clinical trial guidelines, FDA processes and requirements, and overall regulatory constraints.

  8. MOSFET Converter-Fed Position Servo System with Sliding Mode Control

    Microsoft Academic Search

    Fumio Harashima; Hideki Hashimoto; Seiji Kondo

    1985-01-01

    Sliding mode control is an effective means to keep a system insensitive to parametric variations and disturbances. In the conventional sliding mode control applied to position servo systems, the sliding mode regime is restricted near the origin, and, therefore, insensitivity cannot be ensured throughout an entire response. This paper presents a new method in which a sliding curve is used

  9. Design of adaptive sliding mode controller for chaos synchronization with uncertainties

    Microsoft Academic Search

    Her-Terng Yau

    2004-01-01

    In this paper an adaptive sliding mode controller is presented for a class of master–slave chaotic synchronization systems with uncertainties. Using an adaptive technique to estimate the switching gain, an adaptive sliding mode controller is then proposed to ensure that the sliding condition is maintained in finite time. The proposed adaptive sliding mode control scheme can be implemented without the

  10. Was It Something I Ate? Implementation of the FDA Seafood HACCP Program

    Microsoft Academic Search

    Anna Alberini; Erik Lichtenberg; Dominic Mancini; Gregmar I. Galinato

    2005-01-01

    We use FDA's seafood inspection records to examine: (i) how FDA has targeted its inspections under HACCP regulation; (ii) the effects of FDA inspections on compliance with both HACCP and plant sanitation standards; and (iii) the relationship between HACCP regulations and pre-existing sanitation standards. We use a theoretical model of enforcement to derive hypotheses about FDA's targeting of inspections and

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

    Cancer.gov

    The NCL serves as a bridge to take promising cancer nanotechnology research to the FDA. FDA provides input to NCL on the type of testing needed to evaluate nanomaterials for regulatory review, and data generated at NCL inform FDA on which nanoparticle properties contribute most to safety and toxicity. Additionally, the NCL provides the FDA with collaborative research resources.

  12. Aerial View of Slide

    USGS Multimedia Gallery

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

  13. 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...

  14. Animal & Plant Cell Slides

    NSDL National Science Digital Library

    Mission Science Workshop

    2013-01-01

    In this activity, learners make slides of onion cells and their own cheek cells. Use this lab to teach learners how to prepare microscope slides and use a microscope. Learners will also identify differences between plant and animal cells. Note: a microscope is required for this activity, but is not included in the cost of materials.

  15. Financial disclosure by clinical investigators--FDA. Final rule.

    PubMed

    1998-02-01

    The food and Drug Administration (FDA) is issuing regulations requiring the sponsor of any drug, including a biological product, or device marketing application (applicant), to submit certain information concerning the compensation to, and financial interests of any clinical investigator conducting certain clinical studies. This requirement will apply to any covered clinical study of a drug or device submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective, including studies that show equivalence to an effective product, or that make a significant contribution to the demonstration of safety. This final rule requires applicants to certify to the absence of certain financial interests of clinical investigators and/or disclose those financial interests, as required, when covered clinical studies are submitted to FDA in support of product marketing. This regulation is intended to ensure that financial interests and arrangements of clinical investigators that could affect reliability of data submitted to FDA in support of product marketing are identified and disclosed by the sponsor of any drug, biological product, or device marketing application. If the applicant does not include certification or disclosure, or both, if required, or does not certify that it was not possible to obtain the information, the agency may refuse to file the application. FDA intends to propose to extend these requirements to submissions for marketing approval related to human foods, animal foods, and animal drugs in a subsequent issue of the Federal Register. PMID:10177332

  16. 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

  17. FDA reform signed into law. Food and Drug Administration.

    PubMed

    James, J S

    1997-12-01

    The laws under which the Food and Drug Administration (FDA) operates have been changed by bipartisan Congressional efforts. The FDA Modernization Act of 1997, signed into law on November 21, 1997 modifies the mission of the FDA to include a goal of speeding research, innovation and access to care. The legislation allows fast track review for the most important drugs. It also allows drug companies to promote off label use of already-approved pharmaceuticals for other purposes. The controversial issue allows drug companies to provide physicians with documentation on the effectiveness of their drugs in treating other conditions. The industry supports the change since the revenue growth for off label use of drugs is especially important for smaller biotechnical companies, while consumer groups fear that it is a loophole for selling unproven drugs. The bill also renews the Prescription Drug User Fee Act (PDUFA), regulating the current practice of compounding, and monitoring medical devices and health care claims for foods. PMID:11364915

  18. 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

  19. Characteristics of pivotal trials and FDA review of innovative devices.

    PubMed

    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

  20. 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

  1. 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…

  2. 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…

  3. Elastic instabilities at a sliding interface

    NASA Astrophysics Data System (ADS)

    Persson, B. N.

    2001-03-01

    I consider a semi-infinite elastic solid sliding on a flat hard substrate. I present a linear instability analysis to determine when the steady sliding motion becomes unstable with respect to infinitesimal perturbations. I consider a general case where the interfacial frictional shear stress depends not only on the sliding velocity but also on a state variable. I show that when the pressure in the contact area between the solids is constant, no linear instability occurs if the kinetic friction coefficient increases monotonically with the sliding velocity, d?k/dv0>0. However, when the pressure at the interface varies spatially, elastic instabilities may also occur when d?k/dv0>0. I discuss the physical origin of this effect, and suggest that these instabilities may be precursors of the Schallamach waves.

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

    PubMed

    Smith, Jeffrey K

    2013-04-01

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

  5. Recent changes in FDA's good laboratory practice regulations

    Microsoft Academic Search

    Paul D. Lepore

    1990-01-01

    In the Federal Register of December 22, 1978, the Food and Drug Administration (FDA) published regulations which described Good Laboratory Practice for safety tests conducted on regulated products (Anonymous, 1978). The regulations, popularly known as GLPs, have become universally recognized as the basic criteria for the conduct of a valid safety test and for assuring the quality and integrity of

  6. A Process for Compliance with Revisions to FDA Regulations

    Microsoft Academic Search

    David W. Johnson; Nikola Coleman; Kristi Kepler; Wayne Millar

    1998-01-01

    Revisions to Food and Drug Administration (FDA) regulations occur periodically and for a number of reasons. Whenever such a change occurs, it is necessary for pharmaceutical companies to evaluate that change for its products and to set in motion the appropriate actions to comply with the change in the regulations. When a change affects many products from the same pharmaceutical

  7. Software Development Practice for FDA-Compliant Medical Devices

    Microsoft Academic Search

    Weiguo Lin; Xiaomin Fan

    2009-01-01

    Software development in medical devices by implementing lightweight processes in formal regulatory environments is an issue. This paper describes software development practice with the project of Digital Subtraction Angiography (DSA) medical device, and introduces experiences to ensure FDA regulatory compliance In addition, we introduce a hybrid methodology adopted in our software development process which is to use agile method to

  8. The FDA Food Code: What should you know?

    E-print Network

    Jawitz, James W.

    . INFORMATION TO ASSIST THE USER · 9. THE CODE REVISION PROCESS · 10. ACKNOWLEDGMENTS 12 #12;Components of Food ­ Food Warehouses ­ Seafood Markets ­ Poultry & Egg Processing ­ Food Manufacturing ­ Soft Drink BottlingThe FDA Food Code: What should you know? Amy Simonne, Ph.D. Professor, Food Science University

  9. FDA Approves New Treatment for Advanced Colorectal Cancer

    MedlinePLUS

    ... and Oncology Products in FDA’s Center for Drug Evaluation and Research. According to the Centers for Disease Control and Prevention, colorectal cancer is the third most common cancer in men and in women and the third leading cause of cancer death in men and in women in ...

  10. FDA Ban on Harmful Trans Fats Expected Soon

    MedlinePLUS

    ... FDA. They are created by pumping hydrogen into vegetable oil to make it more solid. These oils most often are found in processed foods such as: baked goods like cakes, cookies and pies, nondairy ... shortening, refrigerated dough products such as biscuits and ...

  11. FDA Approves Panobinostat for Some Patients with Multiple Myeloma

    Cancer.gov

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

  12. FDA Issues Warning for Type 2 Diabetes Drugs

    MedlinePLUS

    ... Us Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home ? Latest Health News ? Article URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_152605.html FDA Issues Warning for Type 2 Diabetes Drugs SGLT2 inhibitors linked to potentially fatal ...

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

    PubMed

    Friedman, Richard L

    2011-01-01

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

  14. Slide Projector Activities

    NSDL National Science Digital Library

    Bob Miller

    2013-01-30

    This resource contains several mini-explorations using a slide projector as a light source to investigate light and the properties of images. These activities can be used as a class demonstration or as learning stations. This guide also includes information about the "anatomy" of slide projectors and how they work. Learners and educators are encouraged to "tinker" with the equipment to find the best conditions and methods. Note: the cost of the projector is not included in the total cost of materials.

  15. Rapid preparation of lecture slides.

    PubMed

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

    1985-02-01

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

  16. Medical device EMI: FDA analysis of incident reports, and recent concerns for security systems and wireless medical telemetry

    Microsoft Academic Search

    Donald Witters; Stuart Portnoy; Jon Casamento; Paul Ruggera; Howard Bassen

    2001-01-01

    FDA has evaluated reports of medical device malfunctions caused by electromagnetic interference (EMI), performed device testing, and developed standardized test procedures. Over 500 incident reports are suspected to be attributable to EMI affecting cardiac devices. More than 80 of these reports involve cardiac and other medical device interactions with electronic security systems. EMI presents a risk to patient safety and

  17. Space-Variant Restoration with Sliding Discrete Cosine Transform

    Microsoft Academic Search

    Vitaly Kober; Jacobo Gomez Agis

    2007-01-01

    A local adaptive restoration technique using a sliding discrete cosine transform (DCT) is presented. A minimum mean-square\\u000a error estimator in the domain of a sliding DCT for image restoration is derived. The local restoration is performed by pointwise\\u000a modification of local DCT coefficients. To provide image processing in real time, a fast recursive algorithm for computing\\u000a the sliding DCT is

  18. Actuator Fault Estimation Using Neuro-Sliding Mode Observers

    E-print Network

    Paris-Sud XI, Université de

    Actuator Fault Estimation Using Neuro-Sliding Mode Observers Róbert Fónod and Dusan Krokavec systems, based on neuro-sliding mode observer structure, is presented in this paper. Radial basis function and diagnosis (FDD) algorithm for linear systems is presented in this paper. The FDD scheme is based on neuro

  19. 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…

  20. A sliding mode observer and controller for stabilization of rotational motion of a vertical shaft magnetic bearing

    Microsoft Academic Search

    Ann E. Rundell; Sergey V. Drakunov; Raymond A. DeCarlo

    1996-01-01

    In this paper we present the development of (1) a sliding mode controller for stabilization of the rotational dynamics of a vertical shaft magnetic bearing in addition to providing tracking capabilities, and (2) a sliding mode observer for state and disturbance estimation. Rotor imbalance causes sinusoidal disturbances which necessitates robustness inherent in sliding mode observers and controllers. The sliding mode

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...registration number? (a) FDA will assign each location a...registration number. (b) FDA acceptance of an establishment...that an establishment is in compliance with applicable rules and regulations...P is licensed or approved by...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...registration number? (a) FDA will assign each location a...registration number. (b) FDA acceptance of an establishment...that an establishment is in compliance with applicable rules and regulations...P is licensed or approved by...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...registration number? (a) FDA will assign each location a...registration number. (b) FDA acceptance of an establishment...that an establishment is in compliance with applicable rules and regulations...P is licensed or approved by...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...registration number? (a) FDA will assign each location a...registration number. (b) FDA acceptance of an establishment...that an establishment is in compliance with applicable rules and regulations...P is licensed or approved by...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...registration number? (a) FDA will assign each location a...registration number. (b) FDA acceptance of an establishment...that an establishment is in compliance with applicable rules and regulations...P is licensed or approved by...

  6. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

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

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

    MedlinePLUS

    ... may not be regulated by FDA. Search In Vitro Test Database IVD Over the Counter (OTC) Database ... FDA 301-796-5450 CDRH-Office of In Vitro Diagnostics and Radiological Health Center for Devices and ...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...2011-04-01 false How will FDA handle classified information in an informal hearing... § 1.406 How will FDA handle classified information in an informal hearing...information supporting the detention order is classified under the applicable Executive...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...2010-04-01 false How will FDA handle classified information in an informal hearing... § 1.406 How will FDA handle classified information in an informal hearing...information supporting the detention order is classified under the applicable Executive...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...2013-04-01 false How will FDA handle classified information in an informal hearing... § 1.406 How will FDA handle classified information in an informal hearing...information supporting the detention order is classified under the applicable Executive...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...2012-04-01 false How will FDA handle classified information in an informal hearing... § 1.406 How will FDA handle classified information in an informal hearing...information supporting the detention order is classified under the applicable Executive...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 false How will FDA handle classified information in an informal hearing... § 1.406 How will FDA handle classified information in an informal hearing...information supporting the detention order is classified under the applicable Executive...

  13. Was It Something I Ate? Implementation of the FDA Seafood HACCP Program

    Microsoft Academic Search

    Anna Alberini; Erik Lichtenberg; Dominic Mancini; Gregmar I. Galinato

    2005-01-01

    We use FDA’s seafood inspection records to examine: (i) how FDA has targeted its inspections under HACCP regulation; (ii) the effects of FDA inspections on compliance with both HACCP and plant sanitation standards; and (iii) the relationship between HACCP regulations and pre-existing sanitation standards. We use a theoretical model of enforcement to derive hypotheses about FDA’s targeting of inspections and

  14. January 27, 2010 CUMC Compliance Program for FDA-regulated Human Subjects Research

    E-print Network

    Grishok, Alla

    January 27, 2010 CUMC Compliance Program for FDA-regulated Human Subjects Research The CUMC Compliance Program for FDA-regulated human subjects research (the "Program") is the responsibility. The Program is intended to ensure compliance in the conduct of all FDA-regulated human subjects research

  15. August 25, 2011 Clinical Trials Monitoring Assistance Program for FDA Regulated Human Subjects Research

    E-print Network

    Grishok, Alla

    Research The CUMC Compliance Program for FDA-regulated human subjects research is the responsibilityAugust 25, 2011 Clinical Trials Monitoring Assistance Program for FDA Regulated Human Subjects established in the CTO to assist S-Is in meeting FDA requirements with respect to the monitoring of S

  16. 21 CFR 830.120 - Responsibilities of an FDA-accredited issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...120 Responsibilities of an FDA-accredited issuing agency...assignment of UDIs and provide FDA a copy of such list in electronic...d) Upon request, provide FDA with information concerning...UDIs; and (e) Remain in compliance with the eligibility and...

  17. Clarification of FDA Regulations and Guidance on "Compassionate" and "Humanitarian" Use

    E-print Network

    Puglisi, Joseph

    .34). Stanford University Research Compliance Office "Compassionate" and "Humanitarian" Use [FDA] GUI-36m FileClarification of FDA Regulations and Guidance on "Compassionate" and "Humanitarian" Use The following FDA regulations and guidance make provision for the so-called "compassionate use

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

    E-print Network

    Powell, Robert

    2006-10-26

    Impact of PK/PD, Disease Models and Personalized Medicine to Influence FDA Decisions Bob Powell, Pharm.D. Pharmacometrics Offices of Clinical Pharmacology & Translational Sciences Center for Drug Evaluation & Research FDA robert... ? Prospective trial needed to test hypothesis: HIV protease resistant patients benefit from IQ testing ? Implementation variation in clinical practice ? Hidden elephant: marketing Dilemma ? Inside FDA Clinical Pharmacology was proposing changes. Clinical...

  19. CSc 155 Lecture Note Slides CSc 155 Lecture Note Slides

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Shadows CSc 155 Lecture Note Slides Shadows 2 Shadows - topics · Overview of methods · Shadow Mapping · Dealing with artifacts · Other improvements #12;CSc 155 Lecture Note? Box floating above a table! CSc 155 Lecture Note Slides Shadows 4 one method: "Projective Shadows

  20. Suggested FDA restrictions might curtail access to mifepristone.

    PubMed

    2000-08-01

    In the US, the Food and Drug Administration (FDA) has indicated it might place restrictions on how the abortion drug mifepristone is distributed and who can prescribe it. Some possible restrictions include limiting prescription privileges to doctors performing surgical abortions and requiring certification for mifepristone's use. It is noted that such restrictions could hamper access to the medical abortion method when it receives final FDA approval. In view of this, abortion access advocates posed several questions on the FDA arguing the proposed restrictions. The executive director of the National Abortion Federation, Vicki Saporta stated that such restrictions would disqualify/qualify physicians and would even disqualify some providers of surgical services from offering services to women, thereby denying access to hundreds of thousands of women. In addition, Saporta considers that, while there is a need to make sure that physicians are educated in this method, it is important that as many women as possible who want access to the medication are able to have it. PMID:12349758

  1. Classic Slide Rule

    NSDL National Science Digital Library

    2012-08-03

    In this activity, students construct classic slide rules and use them like calculators. Students use the slide rules to read scales, determine significant figures, and estimate decimal places.  This is activity D3 in the "Far Out Math" educator's guide. Lessons in the guide include activities in which students measure, compare quantities as orders of magnitude, become familiar with scientific notation, and develop an understanding of exponents and logarithms using examples from NASA's GLAST mission. These are skills needed to understand the very large and very small quantities characteristic of astronomical observations. Note: In 2008, GLAST was renamed Fermi, for the physicist Enrico Fermi.

  2. A High Order Sliding Mode Control with PID Sliding Surface: Simulation on a Torpedo

    E-print Network

    Rhif, Ahmed

    2012-01-01

    Position and speed control of the torpedo present a real problem for the actuators because of the high level of the system non linearity and because of the external disturbances. The non linear systems control is based on several different approaches, among it the sliding mode control. The sliding mode control has proved its effectiveness through the different studies. The advantage that makes such an important approach is its robustness versus the disturbances and the model uncertainties. However, this approach implies a disadvantage which is the chattering phenomenon caused by the discontinuous part of this control and which can have a harmful effect on the actuators. This paper deals with the basic concepts, mathematics, and design aspects of a control for nonlinear systems that make the chattering effect lower. As solution to this problem we will adopt as a starting point the high order sliding mode approaches then the PID sliding surface. Simulation results show that this control strategy can attain exce...

  3. Fixed frequency sliding mode modulator for current mode PWM inverters

    Microsoft Academic Search

    J. Fernando Silva; S. S. Paulo

    1993-01-01

    A fixed frequency current mode PWM modulator that provides output current limiting in sliding mode voltage controlled DC-AC power converters is presented. The modulator is considerably simpler than previous solutions and well adapted for sliding mode control, which is advantageous when the inverter feeds nonlinear or wide ranging loads and performs as a switching power operational amplifier or power operational

  4. Sliding mode stabilization of a centrifugal compressor with spool dynamics

    Microsoft Academic Search

    Chau-Chung Song; Song-Shyong Chen; Der-Cherng Liaw

    2009-01-01

    In this paper, the topic of robust stabilization of a centrifugal compressor with spool dynamics is studied and presented. Sliding mode controls for systems with matching-type and mismatching-type uncertainties are separately designed and verified. The sliding mode design is chosen to achieve the stability of the working equilibrium for systems without uncertainties. However, it is known that uncertainties in the

  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. Flow Slide Fall

    NSDL National Science Digital Library

    McGraw-Hill

    This Flash animation displays in quick sequence four different mass wasting events: earthflow, translational slump, rotational slump, and rock fall. Images are attractive but there is little in the way of causative factors involved in mass wasting. To access the animation Click on the "Flow Slide Fall" link.

  7. Title Slide "Failure patterns

    E-print Network

    Hatton, Les

    17-Jan-2007 #12;v. 1.1, 28/Feb/2007, (slide 1 - 3). Copyright Les Hatton 2007- To improve a process and fixing defects · Economist Science Technology Quarterly 19/Jun/2003 Royal Academy of Engineering (UK GBP 17 billion will be wasted in 2003/2004 alone. · "The challenges of complex IT projects", 22/Apr

  8. Flip-n-Slide

    NSDL National Science Digital Library

    2011-01-01

    This interactive game gives students practice in using slides, flips and turns (i.e. translations, reflections and rotations) to maneuver a triangle. The object is to capture fireflies and ladybugs to earn more points than the computer (or an online opponent).

  9. A fuzzy sliding-mode controller design for a synchronous reluctance motor drive

    Microsoft Academic Search

    Tian-Hua Liu; Ming-Tsan Lin

    1996-01-01

    A new method for controlling a synchronous reluctance drive system using a sliding mode with fuzzy controller design is presented. The fuzzy controller is used to adjust the sliding line of the sliding-mode controller. Using this method, the system has a fast response and a good disturbance rejection capability. In addition, the chattering of the speed is reduced. In this

  10. Stochastic optimization of a chain sliding mode controller for the mobile robot maneuvering

    Microsoft Academic Search

    Alexander V. Terekhov; Jean-Baptiste Mouret; Christophe Grand

    2011-01-01

    In this study we present a chain sliding mode controller for the control of a four wheeled autonomous mobile robot performing aggressive turning maneuver to 90 degrees on a slippery surface. The controller consists of a set of local sliding mode controllers and the hyperplanes of switching between them. The parameters of the sliding mode controllers and the hyperplanes are

  11. Analysis and design of a three phase sliding mode controller for a shunt active power filter

    Microsoft Academic Search

    V. Cardenas; N. Viizquez; C. Hernandez; S. Horta

    1999-01-01

    In this paper a three-phase sliding mode controller for a shunt active power filter is presented; analysis, design, simulation and experimental results are included. The sliding mode controller proposed is a three phase controller that considers the overall system, and the loop to regulate the capacitor voltage is added to the sliding mode control strategy. The instantaneous reactive power theory

  12. The Glaucoma Research Community and FDA Look to the Future: A Report from the NEI\\/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium

    Microsoft Academic Search

    Robert N. Weinreb; Paul L. Kaufman

    n March 13-14, 2008, the National Eye Institute (NEI), of the National Institutes of Health (NIH), and the Food and Drug Administration Center for Drug Evaluation and Research (FDA CDER) held the NEI\\/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium to discuss the possible use of new structural and functional endpoints for evaluating glau- coma therapies in clinical trials.

  13. ArrayTrack: an FDA and public genomic tool.

    PubMed

    Fang, Hong; Harris, Stephen C; Su, Zhenjiang; Chen, Minjun; Qian, Feng; Shi, Leming; Perkins, Roger; Tong, Weida

    2009-01-01

    A robust bioinformatics capability is widely acknowledged as central to realizing the promises of toxicogenomics. Successful application of toxicogenomic approaches, such as DNA microarrays, inextricably relies on appropriate data management, the ability to extract knowledge from massive amounts of data, and the availability of functional information for data interpretation. At the FDA's National Center for Toxicological Research (NCTR), we are developing a public microarray data management and analysis software, called ArrayTrack, that is also used in the routine review of genomic data submitted to the FDA. ArrayTrack stores a full range of information related to DNA microarrays and clinical and non-clinical studies as well as the digested data derived from proteomics and metabonomics experiments. In addition, ArrayTrack provides a rich collection of functional information about genes, proteins, and pathways drawn from various public biological databases for facilitating data interpretation. Many data analysis and visualization tools are available with ArrayTrack for individual platform data analysis, multiple omics data integration, and integrated analysis of omics data with study data. Importantly, gene expression data, functional information, and analysis methods are fully integrated so that the data analysis and interpretation process is simplified and enhanced. Using ArrayTrack, users can select an analysis method from the ArrayTrack tool box, apply the method to selected microarray data, and the analysis of results can be directly linked to individual gene, pathway, and Gene Ontology analysis. ArrayTrack is publicly available online ( http://www.fda.gov/nctr/science/centers/toxicoinformatics/ArrayTrack/index.htm ) and the prospective user can also request a local installation version by contacting the authors. PMID:19597796

  14. 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.

  15. Static and dynamic friction in sliding colloidal monolayers

    PubMed Central

    Vanossi, Andrea; Manini, Nicola; Tosatti, Erio

    2012-01-01

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

  16. Develop and Manufacture an airlock sliding tray

    SciTech Connect

    Lawton, Cindy M. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    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.

  17. Detection of felt tip markers on microscope slides

    NASA Astrophysics Data System (ADS)

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

    2014-03-01

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

  18. 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

  19. Drug development in inflammatory bowel disease: the role of the FDA.

    PubMed

    Lahiff, Conor; Kane, Sunanda; Moss, Alan C

    2011-12-01

    All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general. PMID:21484967

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

    E-print Network

    Demaine, Erik

    disturbing any other coins during the motion. The rest of this section presents several sliding­coin puzzles to another using the fewest possible moves. Coins are identical in size, but may be distinguished by labels

  1. Sliding-Coin Puzzles Erik D. Demaine Martin L. Demaine

    E-print Network

    Demaine, Erik

    disturbing any other coins during the motion. The rest of this section presents several sliding-coin puzzles to another using the fewest possible moves. Coins are identical in size, but may be distinguished by labels

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

    ERIC Educational Resources Information Center

    Barra, Maria; Ferrandino, Salvatore; Scarano, Vittorio

    1999-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  4. Instructions for Authors of Presentations

    Microsoft Academic Search

    S. E. Henrickson; T. R. Mempel; I. B. Mazo; B. Liu; M. N. Artyomov; H. Zheng; A. Peixoto; M. Flynn; B. Senman; T. Junt; H. C. Wong; A. K. Chakraborty

    Format: The text should include a brief abstract; the title, authors with the presenting author indicated; location, and dates of the meeting where the talk was initially presented; a description for each slide; and a reference section. All literature cited in the slides must also be cited in the text, although the text may include additional citations not used in

  5. 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

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

    PubMed Central

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

    2013-01-01

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

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

    SciTech Connect

    Mahjoub, Sonia; Derbel, Nabil [Research unit on Intelligent Control, design and Optimization of complex Systems (ICOS) National engineering school of sfax, BP W, 3038 Sfax (Tunisia); Mnif, Faical [Department of Electrical and Computer Engineering Sultan Qaboos University, Muscat (Oman)

    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.

  8. Rock Slide in Ophir

    NASA Technical Reports Server (NTRS)

    2004-01-01

    7 May 2004 The dark streaks, just left of center, on the steep slope in this Mars Global Surveyor (MGS) Mars Orbiter Camera (MOC) image were formed by a relatively recent rock slide. The streak closest to the center of the image resolves into a series of small depressions, indicating the path of a large, rolling boulder. The rock slide is inferred to have been recent (i.e., within the past several Mars years) because it is so much darker than its surroundings--there has not been sufficient time for the streak surfaces to become mantled by dust. The other talus accumulations on this slope are most likely lighter in tone because they are older and coated with dust. These features are located in Ophir Chasma, part of the Valles Marineris trough system, near 4.2oS, 74.0oW. The picture is illuminated by sunlight from the lower left and covers an area about 3 km (1.9 mi) across.

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

    Microsoft Academic Search

    James Saviola

    2005-01-01

    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

  10. A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels

    E-print Network

    de Weck, Olivier L.

    A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels-Making Applied to FDA Medical Device Panels by David André Broniatowski Submitted to the Engineering Systems and electronic copies of this thesis document in whole or in part in any medium now known or hereafter created

  11. A Novel Systematic Method of Quality Monitoring and Prediction Based on FDA and Kernel Regression

    Microsoft Academic Search

    Xi ZHANG; Sile MA; Weiwu YAN; Xu ZHAO; Huihe SHAO

    2009-01-01

    A novel systematic quality monitoring and prediction method based on Fisher discriminant analysis (FDA) and kernel regression is proposed. The FDA method is first used for quality monitoring. If the process is under normal condition, then kernel regression is further used for quality prediction and estimation. If faults have occurred, the contribution plot in the fault feature direction is used

  12. 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…

  13. Was It Something I Ate? Implementation of the FDA Seafood HACCP Program

    Microsoft Academic Search

    Dominic Mancini; Gregmar I. Galinato

    2008-01-01

    We develop a theoretical model of enforcement and compliance under HACCP regulation and use the FDA's seafood inspection records to examine: (1) if the FDA has targeted its inspections under HACCP regulation; (2) the effects of inspections on compliance with HACCP and plant sanitation standards; and (3) the relationship between compliance with HACCP and preexisting sanitation standards. There is some

  14. Inspection of Computer-Supported Toxicological Data Submitted to the FDA

    Microsoft Academic Search

    D. W. Taylor

    1984-01-01

    The FDA's Good Laboratory Practices Regulations (GLP) have been formally amended (once) and two formal advisory opinions have been issued. The FDA is now in the process of reviewing the GLPs to comply with both the Regulatory Flexibility Act of 1980 and Executive Order 12291 of 1981. Inspections since 1979 have revealed compliance progress; however, certain areas of the GLPs

  15. Was It Something I Ate? Implementation of the FDA Seafood HACCP Program

    Microsoft Academic Search

    Anna Alberini; Erik Lichtenberg; Dominic Mancini; Gregmar I. Galinato

    2008-01-01

    We develop a theoretical model of enforcement and compliance under HACCP regulation and use the FDA's seafood inspection records to examine: (1) if the FDA has targeted its inspections under HACCP regulation; (2) the effects of inspections on compliance with HACCP and plant sanitation standards; and (3) the relationship between compliance with HACCP and preexisting sanitation standards. There is some

  16. 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

  17. THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN

    E-print Network

    Mateo, Jill M.

    ,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. Just before the FDA warnings, adolescents with probable depression had grade point averages 0.14 points higher than adolescents with depression just after

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...Drugs 2 2013-04-01 2013-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs...LABELING Pt. 101, App. B Appendix B to Part 101—Graphic Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...Drugs 2 2011-04-01 2011-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs...LABELING Pt. 101, App. B Appendix B to Part 101—Graphic Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  20. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...Drugs 2 2012-04-01 2012-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs...LABELING Pt. 101, App. B Appendix B to Part 101—Graphic Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...Drugs 2 2010-04-01 2010-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs...LABELING Pt. 101, App. B Appendix B to Part 101—Graphic Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  2. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...Drugs 2 2014-04-01 2014-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs...LABELING Pt. 101, App. B Appendix B to Part 101—Graphic Enhancements Used by the FDA ER01JA93.364 ER11JY03.006...

  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. Presentation Tips Joe Sawada -University of Guelph

    E-print Network

    Sawada, Joe

    Presentation Tips 3 / 1 Slides: Title page Your title page should have the following: Title Name of presenterPresentation Tips CIS 6890 Joe Sawada - University of Guelph CIS 6890 Presentation Tips 1 / 1 slides 3. Other presentation tips CIS 6890 Presentation Tips 2 / 1 Three Steps to Success 1. Know Thy

  5. Bureau of Radiological Health. a look at Food and Drug Administration's (FDA's) program to protect the American consumer from radiaton. Final report

    Microsoft Academic Search

    R. C. Eccleston; M. H. Barnett

    1977-01-01

    The report provides a brief overview of the FDA's major regulatory and voluntary efforts in the area of radiation control, and examines the impact of the Agency's programs to eliminate unproductive radiation exposure to the American consumer. It concludes with a summary of present and future concerns about newly emerging radiation-emitting products and uses, and the potential public health problems

  6. 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.

  7. 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.

  8. Sliding mode thermal control system for space station furnace facility

    Microsoft Academic Search

    Mark E. Jackson; Yuri B. Shtessel

    1998-01-01

    This paper addresses the decoupled control of the nonlinear, multi-input-multi-output, highly coupled space station furnace facility (SSFF) thermal control system. 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

  9. Grooved organogel surfaces towards anisotropic sliding of water droplets.

    PubMed

    Zhang, Pengchao; Liu, Hongliang; Meng, Jingxin; Yang, Gao; Liu, Xueli; Wang, Shutao; Jiang, Lei

    2014-05-21

    Periodic micro-grooved organogel surfaces can easily realize the anisotropic sliding of water droplets attributing to the formed slippery water/oil/solid interface. Different from the existing anisotropic surfaces, this novel surface provides a versatile candidate for the anisotropic sliding of water droplets and might present a promising way for the easy manipulation of liquid droplets for water collection, liquid-directional transportation, and microfluidics. PMID:24610716

  10. Multiplying Slide Rule

    NSDL National Science Digital Library

    2012-08-03

    In this activity students construct multiplying slide rules scaled in Base-10 exponents and use them to calculate products and quotients. They will come to appreciate that super numbers (exponents, orders of magnitude and logarithms) play by different rules of arithmetic than ordinary numbers (numbers, powers of ten and antilogs).  This is activity A2 in the "Far Out Math" educator's guide. Lessons in the guide include activities in which students measure,compare quantities as orders of magnitude, become familiar with scientific notation, and develop an understanding of exponents and logarithms using examples from NASA's GLAST mission. These are skills needed to understand the very large and very small quantities characteristic of astronomical observations. Note: In 2008, GLAST was renamed Fermi, for the physicist Enrico Fermi.

  11. Slide-Rule Graph

    NSDL National Science Digital Library

    In this activity students use their Log Tapes as a reference for ordered pairs, and graph positive numbers as a function of their base-10 logarithms. They extend each plotted point to the vertical axis, thereby generating a logarithmic scale that cuts and folds into an improvised slide rule. This is activity E1 in the "Far Out Math" educator's guide. Lessons in the guide include activities in which students measure,compare quantities as orders of magnitude, become familiar with scientific notation, and develop an understanding of exponents and logarithms using examples from NASA's GLAST mission. These are skills needed to understand the very large and very small quantities characteristic of astronomical observations. Note: In 2008, GLAST was renamed Fermi, for the physicist Enrico Fermi. 

  12. New FDA informed consent regulation: ClinicalTrials.gov requirement To comply with a new FDA informed consent regulation, the MCW/FH IRB has updated the A Template

    E-print Network

    New FDA informed consent regulation: ClinicalTrials.gov requirement To comply with a new FDA-written to come into compliance with 21 CFR 50.25. On and after March 7, 2012 all clinical trials initiated

  13. The Effect of Iron Addition on the Dry Sliding Wear and Corrosion Behavior of Cu Al Ni Shape Memory Alloy

    Microsoft Academic Search

    Abdul Raheem; K. Abid Ali; Zuheir T. Khulief

    2010-01-01

    In this paper, dry sliding wear and corrosion behavior of Cu + 13wt% Al + 3.8 wt% Ni was prepared by powder metallurgy. Dry sliding wear has been studied based on pin on disk at constant velocity and constant sliding distance .Corrosion behavior in 5 wt% NaOH solution based up on potentiostatic ( Tafel ) has been presented for base

  14. Asymmetric kinematic changes in speaking rate explored with FDA

    NASA Astrophysics Data System (ADS)

    Lee, Sungbok; Narayanan, Shrikanth; Byrd, Dani

    2003-10-01

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

  15. CSc 155 Lecture Note Slides Composite Models

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Composite Models CSc 155 Lecture Note Slides Composite Models 2 Many the entire curve) #12;CSc 155 Lecture Note Slides Composite Models 3 "Piecewise" Curves · Connect multiple" ) "Piecewise-Cubic" curve CSc 155 Lecture Note Slides Composite Models 4 Piecewise Surfaces · Combining bicubic

  16. CSc 155 Lecture Note Slides Texture Mapping

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Texture Mapping CSc 155 Lecture Note Slides Texture Mapping 2 Attaching Images to Objects · Basic idea: + = Object Image "Textured Object" #12;CSc 155 Lecture Note Slides" "Textured Object" CSc 155 Lecture Note Slides Texture Mapping 4 Image File Formats · Graphics Interchange

  17. CSc 155 Lecture Note Slides Materials and

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Materials and Lighting ("Shading") CSc 155 Lecture Note Slides source "Ambient" light Ieye = Iamb + Idiff + Ispec #12;CSc 155 Lecture Note Slides Materials and Lighting "properties" 3 CSc 155 Lecture Note Slides Materials and Lighting Explicit Light Types · Point source

  18. CSc 155 Lecture Note Slides Bump Mapping

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Bump Mapping CSc 155 Lecture Note Slides Bump Mapping 2 Limitations would be deflected off of the texture #12;CSc 155 Lecture Note Slides Bump Mapping 3 Bumps: Perturbed CSc 155 Lecture Note Slides Bump Mapping 4 Bump Functions 1.1)8sin()( uub 1.0 2.0 8 0 1 u Original

  19. CSc 155 Lecture Note Slides Geometry Shaders

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Geometry Shaders CSc 155 Lecture Note Slides Geometry Shaders 2, output additional primitives, delete the primitive (not output it) #12;CSc 155 Lecture Note Slides].gl_Position //position of 3rd vertex CSc 155 Lecture Note Slides Geometry Shaders 4 Details · Inputs

  20. Thermal imaging on simulated faults during frictional sliding

    E-print Network

    Mair, Karen; Gundersen, Olav

    2008-01-01

    Heating during frictional sliding is a major component of the energy budget of earthquakes and represents a potential weakening mechanism. It is therefore important to investigate how heat dissipates during sliding on simulated faults. We present results from laboratory friction experiments where a halite (NaCl) slider held under constant load is dragged across a coarse substrate. Surface evolution and frictional resistance are recorded. Heat emission at the sliding surface is monitored using an infra-red camera. We demonstrate a link between plastic deformations of halite and enhanced heating characterized by transient localized heat spots. When sand 'gouge' is added to the interface, heating is more diffuse. Importantly, when strong asperities concentrate deformation, significantly more heat is produced locally. In natural faults such regions could be nucleation patches for melt production and hence potentially initiate weakening during earthquakes at much smaller sliding velocities or shear stress than pre...

  1. Thermal imaging on simulated faults during frictional sliding

    NASA Astrophysics Data System (ADS)

    Mair, Karen; Renard, François; Gundersen, Olav

    2006-10-01

    Heating during frictional sliding is a major component of the energy budget of earthquakes and represents a potential weakening mechanism. It is therefore important to investigate how heat dissipates during sliding on simulated faults. We present results from laboratory friction experiments where a halite (NaCl) slider held under constant load is dragged across a coarse substrate. Surface evolution and frictional resistance are recorded. Heat emission at the sliding surface is monitored using an infra-red camera. We demonstrate a link between plastic deformations of halite and enhanced heating characterized by transient localized heat spots. When sand `gouge' is added to the interface, heating is more diffuse. Importantly, when strong asperities concentrate deformation, significantly more heat is produced locally. In natural faults such regions could be nucleation patches for melt production and hence potentially initiate weakening during earthquakes at much smaller sliding velocities or shear stress than previously thought.

  2. CSc 155 Lecture Note Slides CSc 155 Lecture Note Slides

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Parametric Surfaces CSc 155 Lecture Note Slides Parametric Surfaces 2 Recursive Subdivision · OpenGL Evaluators · Geometry Shaders · Tessellation Shaders #12;CSc 155 Lecture Note for curves: P0 P1 P2 P3 Curve C = [ P0, P1, P2, P3 ] )()( 3 0 tBPtP i i i P(t) t=0 t=1 CSc 155 Lecture Note

  3. 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

    ...any regulatory action before FDA that involves the former employer...any regulatory action before FDA in which the employee had...petitions, matters dealing with compliance in areas of radiation-producing...who may have represented an FDA-regulated firm or...

  4. 45 CFR 73a.735-201 - Control activity employees formerly associated with organizations subject to FDA regulation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...any regulatory action before FDA that involves the former employer...any regulatory action before FDA in which the employee had...petitions, matters dealing with compliance in areas of radiation-producing...who may have represented an FDA-regulated firm or...

  5. 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

    ...any regulatory action before FDA that involves the former employer...any regulatory action before FDA in which the employee had...petitions, matters dealing with compliance in areas of radiation-producing...who may have represented an FDA-regulated firm or...

  6. 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

    ...any regulatory action before FDA that involves the former employer...any regulatory action before FDA in which the employee had...petitions, matters dealing with compliance in areas of radiation-producing...who may have represented an FDA-regulated firm or...

  7. 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

    ...any regulatory action before FDA that involves the former employer...any regulatory action before FDA in which the employee had...petitions, matters dealing with compliance in areas of radiation-producing...who may have represented an FDA-regulated firm or...

  8. New drugs for human use; clarification of requirements for patent holder notification--FDA. Proposed rule.

    PubMed

    1998-03-01

    The Food and Drug Administration (FDA) is proposing to amend its regulations on notice of certification of invalidity or noninfringement of a patent to provide additional methods for new drug and abbreviated new drug applicants to provide notice to patent owners and new drug application (NDA) holders, without removing the existing means. These proposed amendments reflect current business practices and are intended to ensure that notice is provided to patent owners and NDA holders in a timely manner. FDA is also proposing to require certain applicants to submit to FDA a copy of the notice of certification. PMID:10177511

  9. Adaptive fault tolerant control using integral sliding mode strategy with application to flexible spacecraft

    Microsoft Academic Search

    Qinglei Hu; Bing Xiao

    2012-01-01

    Adaptive-based integral sliding mode control scheme is developed to solve the actuator fault-tolerant compensation problem for linear time-invariant system in the presence of unknown actuator faults and external disturbances. A nonlinear integral-type sliding manifold is first presented that incorporates a virtual nominal control to achieve prescribed specifications of the perturbed system, and an adaptive sliding mode controller is constructed to

  10. A simplified adaptive robust backstepping approach using sliding modes and a z-swapping identifier

    Microsoft Academic Search

    Jason J. Gorman; K. W. Jablokow; D. J. Cannon

    2003-01-01

    An adaptive robust backstepping approach using sliding modes and a z-swapping identifier is presented for a class of nonlinear parameter-varying systems. Each of the first nonlinear-1 virtual control inputs is designed using a zero-order sliding mode controller. Then, in the final step, a general sliding mode controller is used to stabilize the entire closed loop system. The parameter update law

  11. Commentary: Public outreach by the FDA: evaluating oversight of human drugs and medical devices.

    PubMed

    Frankel, Mark S

    2009-01-01

    As nanotechnology emerges as an important public policy issue, the FDA's relationship with society is about to be tested. Most would agree that fostering public input will be critical to developing effective public policy for nanotechnology. Yet, it will not be easy. Low public confidence in the FDA, the general lack of knowledge about nanotechnology among ordinary Americans, and the way in which the "average" citizen obtains and evaluates knowledge about a public policy issue all pose serious challenges to any public outreach by the FDA. It will be necessary for the FDA to be attentive to not only its own public messages, but also to who is listening and how those messages are being perceived. PMID:20122104

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  15. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    SciTech Connect

    Not Available

    1982-10-01

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

  17. FDA Advisers Recommend Approval of First of 2 New Cholesterol Drugs

    MedlinePLUS

    FDA Advisers Recommend Approval of First of 2 New Cholesterol Drugs Trials show they slash levels of ' ... of the first of two drugs in a new class of cholesterol medications that sharply cut "bad" ...

  18. 21 CFR 801.57 - Discontinuation of legacy FDA identification numbers assigned to devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...legacy FDA identification numbers assigned to devices. 801.57 Section 801.57 Food...HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements for Unique Device Identification § 801.57...

  19. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ...FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research...entitled ``Commercially Distributed In Vitro Diagnostic Products Labeled for Research...and investigational use only (IUO) in vitro diagnostic (IVD) products and any...

  20. Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication

    MedlinePLUS

    ... into Blood Vessels in the Face: FDA Safety Communication Date Issued: May 28, 2015 Audiences: Health care ... blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients ...

  1. Regulation of Animal Health Products FDA/CVM: Animal drugs, animal

    E-print Network

    ://www.fda.gov/AnimalVeterinary/, then Click on Animal Health Literacy Click on Animal Health Literacy Campaign Aquaculture-specific references: A Quick Reference Guide to Approved Drugs for Use in Aquaculture Aquaculture and Aquaculture

  2. 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

  3. 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.

  4. Silent Warning: The FDA's Ban on Off-Label Speech: Is it Protecting our Safety?

    Microsoft Academic Search

    Briana R. Barron

    2011-01-01

    The FDA’s regulation of off-label uses for drugs has been a hotly contested issue. While the FDA seeks to ensure compliance with the regulatory process, drug manufacturers argue that off-label prescribing is a well-regarded practice by physicians and that the regulations and the regulations are impermissible under the First Amendment. Recent cases court cases have ended without a clear resolution

  5. Delegations of authority and organization; issuance of written notices--FDA. Final rule.

    PubMed

    1992-05-01

    The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to the issuance of written notices concerning failure to file patent information and to comply with requirements pertaining to current good manufacturing practices and labeling for new drugs, new animal drugs, and feeds bearing or containing new animal drugs from the Commissioner of Food and Drugs to certain FDA officials. This action is being taken to make the process of issuing written notices more efficient. PMID:10118461

  6. 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

  7. 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

  8. The physics of sliding cylinders and curling rocks

    NASA Astrophysics Data System (ADS)

    Penner, A. Raymond

    2001-03-01

    The lateral deflection of a rotating cylindrical shell sliding on one of its ends is considered and both theoretical and experimental results are presented. The coefficient of kinetic friction between a curling rock and an ice surface is then derived and compared with experiment. Current models of the motion of a curling rock are discussed and an alternate hypothesis is presented.

  9. Sliding surface design for discrete VSS using LQR technique with a preset real eigenvalue

    Microsoft Academic Search

    Choon Yik Tang; Eduardo A. Misawa

    1999-01-01

    This paper presents an LQR-based sliding surface design procedure that takes, in addition to the desired weighting matrix, a preset real eigenvalue consequential in discrete VSS as inputs. A weighting matrix that simultaneously stays “closest” to the desired one and yields the preset eigenvalue is sought. Sliding surface is then determined from the optimal gain matrix and the preset eigenvalue.

  10. Sliding surface design for discrete VSS using LQR technique with a preset real eigenvalue

    Microsoft Academic Search

    Choon Yik Tang; Eduardo A. Misawa

    2002-01-01

    This paper presents an LQR-based sliding surface design procedure that allows one to specify a desired weighting matrix and a desired real eigenvalue which is important in discrete VSS. The procedure computes a weighting matrix that simultaneously stays “closest” to the desired one and yields the desired eigenvalue. Sliding surface is then determined from the LQR gain matrix and the

  11. A Novel Sliding Mode Observer with Adaptive Feedback Gain for PMSM Sensorless Vector Control

    Microsoft Academic Search

    S. Chi; Z. Zhang; L. Xu

    2007-01-01

    A novel sliding mode observer (SMO) with adaptive feedback gain is presented for sensorless vector control of permanent magnet synchronous machines (PMSM). The rotor position angle is estimated based on the equivalent control in the sliding mode observer. By selecting adaptive feedback gain, the equivalent control has the same constant magnitude as rotor flux over full speed range. Compared to

  12. Speed Sensorless Control of PMSM Using An Improved Sliding Mode Observer With Sigmoid Function

    Microsoft Academic Search

    Kittithuch Paponpen; Mongkol Konghirun

    2006-01-01

    An improved sliding mode observer is presented to estimate the rotor position of the permanent mag- net synchronous motors (PMSMs). In this observer, the discontinuous control is replaced by using the sig- moid function in order to reduce the chattering prob- lem commonly found in the conventional sliding mode observer. When the chattering is reduced, the back emf can be

  13. Sensorless PMSM drive with a sliding mode control based adaptive speed and stator resistance estimator

    Microsoft Academic Search

    Yoon-Seok Han; Jung-Soo Choi; Young-Seok Kim

    2000-01-01

    This paper presents a new speed and position sensorless control method of permanent magnet synchronous motors based on the sliding mode observer. The sliding mode observer structure and its design method are described. Also, Lyapunov functions are chosen for determining the adaptive law for the speed and the stator resistance estimator. The effectiveness of the proposed observer is confirmed by

  14. 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...

  15. 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…

  16. Optimal positioning control of a DC servo motor using sliding mode

    Microsoft Academic Search

    Gwo-Ruey Yu; Ming-Hung Tseng; Yuan-Kai Lin

    2004-01-01

    This work has presented a novel methodology that is applied to control the position of a DC servomotor. The design is composed of the optimal linear quadratic regulator (LQR) and the sliding mode control. The control strategy is realized through the digital signal processor (DSP). Moreover, the proposed technique is compared with LQR and sliding mode control, respectively. Both the

  17. Slide 1 Lecture 18 Amitabh Varshney

    E-print Network

    Jacobs, David

    ·1 Slide 1 Lecture 18 Copyright Amitabh Varshney Shadows (Georges de la Tour) Slide 2 Lecture 18 Copyright Amitabh Varshney ·Shadows give us important visual cues about 3D object placement and motion? #12;·2 Slide 3 Lecture 18 Copyright Amitabh Varshney Why Shadows ? Also, realism ... Image courtesy

  18. Slide 1 Lecture 20 Amitabh Varshney

    E-print Network

    Jacobs, David

    ·1 Slide 1 Lecture 20 Copyright Amitabh Varshney Modeling Overview · Goal: Represent 3D objects, parametric, procedural modeling Slide 2 Lecture 20 Copyright Amitabh Varshney Getting Models · By hand · By program · From the world #12;·2 Slide 3 Lecture 20 Copyright Amitabh Varshney 3D Sensing with Laser

  19. Slide 1 Lecture 19 Amitabh Varshney

    E-print Network

    Jacobs, David

    ·1 Slide 1 Lecture 19 Copyright Amitabh Varshney Radiosity · Local Lighting (OpenGL). ­ Captures 19 Copyright Amitabh Varshney Does this matter? Is it black here? #12;·2 Slide 3 Lecture 19 Copyright Amitabh Varshney (Wikipedia) Slide 4 Lecture 19 Copyright Amitabh Varshney Radiosity · Global

  20. 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…

  1. CSc 155 Lecture Note Slides Height Mapping

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Height Mapping CSc 155 Lecture Note Slides Height Mapping 2 Consider a monochrome image where pixel intensity represents "height" Low values (black) = low height High values (white) = high height "Height Field" Image "Tilted" View "Edge-on" View #12;CSc 155 Lecture Note Slides

  2. CSc 155 Lecture Note Slides Tessellation

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Tessellation Shaders CSc 155 Lecture Note Slides Tessellation Shaders of the vertices that are rendered by the rasterizer 2 #12;CSc 155 Lecture Note Slides Tessellation Shaders Typical code control pts control pts vertices tessellator tessLevels tessCoords (grid) CSc 155 Lecture Note

  3. CSc 155 Lecture Note Slides Overview of

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides Overview of OpenGL CSc 155 Lecture Note Slides OpenGL overview 2 support #12;CSc 155 Lecture Note Slides OpenGL overview 3 OpenGL ARB: Khronos WG · The Khronos Group: an "Open Standard API" industry consortium · OpenGL "ARB" is a "Khronos Working Group" CSc 155 Lecture Note

  4. 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.

  5. Stop the Summer Reading Slide

    ERIC Educational Resources Information Center

    Lundstrom, Meg

    2005-01-01

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

  6. Smoke Conditions from Slide Fire

    USGS Multimedia Gallery

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

  7. Sliding discharge optical emission characteristics

    Microsoft Academic Search

    V. Lago; D. Grondona; H. Kelly; R. Sosa; A. Marquez; G. Artana

    2009-01-01

    In this work, several optical studies in an atmospheric pressure sliding plasma sheet have been performed. This discharge is generated using two electrodes flush mounted on an insulating flat plate (upper electrodes), and a third electrode flush placed on the opposite side of the plate facing the upper inter electrode gap (lower electrode). A DC negative voltage is applied to

  8. 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.

  9. Herbaceous Ornamental Plants. Slide Script.

    ERIC Educational Resources Information Center

    Still, Steven

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

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

    PubMed

    Rulis, Alan M; Levitt, Joseph A

    2009-02-01

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

  11. Dielectrophoretic Segregation of Different Human Cell Types on Microscope Slides

    PubMed Central

    Das, Chandra M.; Becker, Frederick; Vernon, Suzanne; Noshari, Jamileh; Joyce, Celine; Gascoyne, Peter R. C.

    2005-01-01

    A new method for preparing cells for microscopic examination is presented in which cell mixtures are fractionated by dielectrophoretic forces and simultaneously collected into characteristic zones on slides. The method traps cells directly from the suspending medium onto the slide, reducing cell loss. Furthermore, it exploits differences in the dielectric properties of the cells, which sensitively reflect their morphology. Because different cell types are trapped in characteristic zones on the slide, the technique represents an advance over existing methods for slide preparation, such as centrifugation and smears where cells are randomly distributed. In particular, the new method should aid in the detection of rare and anomalous cell subpopulations that might otherwise go unnoticed against a high background of normal cells. As well as being suitable for traditional microscopic examination and automated slide scanning approaches, it is compatible with histochemical and immunochemical techniques, as well as emerging molecular and proteomic methods. This paper describes the rationale and design of this so-called electrosmear instrumentation and shows experimental results that verify the theory and applicability of the method with model cell lines and normal peripheral blood subpopulations. PMID:15859584

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

    E-print Network

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

    2014-01-01

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

  13. Sliding mode predictive control for long delay time systems

    NASA Astrophysics Data System (ADS)

    da, Feipeng

    2006-01-01

    Delay time, which may degrade the control performance, is frequently encountered in various systems. In this Letter, a sliding mode controller (SMC) based on fuzzy prediction algorithm is presented to control the long delay systems. According to the characteristics of the long delay systems, we simulate the manual operating process and predict the delayed error and its increment based on the information of the input and output variables of the system, and then feedback these prediction values to the sliding mode controller. Simulation examples demonstrate the advantages of the proposed control scheme.

  14. DIRTY DANCING—THE FDA STUMBLES WITH THE CHEVRON TWO-STEP: A RESPONSE TO PROFESSOR NOAH

    Microsoft Academic Search

    Gary Lawson

    Professor Lars Noah deserves much credit for exposing some of the myriad ways in which the Food and Drug Administration (FDA) has consistently sought to expand its authority through questionable, and perhaps in some cases abusive, legal practices.1 As Professor Noah observes, there are signs that the federal courts' century-long honeymoon with the FDA may be ending2—and perhaps the FDA

  15. 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

  16. FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages

    MedlinePLUS

    ... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Foodborne Illness & Contaminants Buy, Store & Serve Safe Food FDA Regulates ...

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

    NASA Astrophysics Data System (ADS)

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

    2014-06-01

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

  18. Mitosis Extraction in Breast-Cancer Histopathological Whole Slide Images

    E-print Network

    Lezoray, Olivier

    Mitosis Extraction in Breast-Cancer Histopathological Whole Slide Images Vincent Roullier1. In this paper, we present a graph-based multi-resolution ap- proach for mitosis extraction in breast cancer staining of mitosis is able to facilitate their detection. Nevertheless, the visual counting method remains

  19. Paper Generators: Harvesting Energy from Touching, Rubbing and Sliding

    E-print Network

    Poupyrev, Ivan

    Paper Generators: Harvesting Energy from Touching, Rubbing and Sliding Mustafa Emre Karagozler1, PA 15213 USA ABSTRACT We present a new energy harvesting technology that generates electrical energy from a user's interactions with paper-like materials. The energy harvesters are flexible, light

  20. Linear-Grating Triboelectric Generator Based on Sliding Electrification

    E-print Network

    Wang, Zhong L.

    form alternating current between electrodes as reciprocating sliding friction occurs. With linear current, and current frequency. The TEG was demonstrated to be an efficient power source humidity, corrosive chemicals or gases, and in water or other liquids. In this paper, we present a new

  1. 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...

  2. A Novel Corner Detector Approach using Sliding Ellipses

    Microsoft Academic Search

    Muhammad Sarfraz; Zar Nawab Khan Swati; Safdar Zaman

    2009-01-01

    This paper introduces a new corner detection approach for planar digital curves. The proposed algorithm finds the corners by sliding set of three ellipses along the curve and counting number of contour points lying in each ellipse. A comparative study with three popular existing corner detectors is also presented.

  3. Sliding mode controller for stability enhancement of MicroGrids

    Microsoft Academic Search

    M. H. Abdollahi; S. M. T. Bathaee

    2008-01-01

    In this paper a new control strategy for stability enhancement of MicroGrid (MG) is presented. Due to nonlinear and stochastic behavior of MGs and the probability existence of a severe disturbance, which is named islanding, the proposed controller is based on Sliding Mode Control (SMC). This controller is very practical for MGs; if a Distributed Generation (DG) in MG is

  4. Requirements for accrediting bodies of mammography facilities--FDA. Interim rule with request for comments.

    PubMed

    1993-12-21

    The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA), which requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This rule establishes procedures for application to FDA for approval as an accrediting body and requirements and responsibilities of such bodies. This action is being taken to assure adequate and consistent evaluation of mammography facilities on a nationwide level and to help assure their compliance with quality standards. The agency requests comments on the contents of this document. PMID:10131224

  5. Slide 1 Fig 7-1, p.154 Planet Earth

    E-print Network

    Wardle, Mark

    Slide 1 Fig 7-1, p.154 Planet Earth #12;Slide 2 The New Solar System ch9 #12;Slide 3 Fig 7-2, p.155 Interior Structure of the Earth #12;Slide 4 Fig 7-4, p.156 Earth!s Magnetosphere #12;Slide 5 The New Solar System ch9 #12;Slide 6 Fig 7-3, p.155 Earth!s Crust #12;Slide 7 Fig 7-6, p.157 Earth!s Continental Plates

  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. How Proteins Slide on DNA

    Microsoft Academic Search

    Daniel Barsky; Ted A. Laurence; ?eslovas Venclovas

    \\u000a Protein–DNA interactions are required for all the major functions of DNA: ­transcription and regulation, replication and repair,\\u000a even the packaging of DNA into chromosomes. Not only are protein–DNA interactions crucial for all these cellular activities,\\u000a but they are also, in our view, among the most fascinating macromolecular­ interactions because of their dynamics. In this\\u000a chapter, we focus on DNA sliding

  8. 3D DEM analyses of the 1963 Vajont rock slide

    NASA Astrophysics Data System (ADS)

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

    2013-04-01

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

  9. Dry Sliding of Metal on Metal

    NASA Astrophysics Data System (ADS)

    Liou, N. S.; Prakash, V.

    1999-06-01

    In the present study plate impact pressure shear friction experiments are conducted to provide insight into time-resolved dry sliding characteristics of frictional interfaces at normal pressures of approximately 1.5 to 2 GPa, interfacial slip speeds of approximately 100 m/s and interfacial temperatures as high as 800 degrees centigrade. These experiments represent a significant improvement over conventional dynamic friction experiments by allowing the interpretation of critical friction parameters by using the framework of one-dimensional plane wave analysis. The experiments are conducted on Carpentor Hampden tool-steel/7075-T6 Al and tool-steel/Ti6Al4V tribo pairs. By an appropriate selection of the flyer and target plate thickness, the frictional state at the tribo-pair interface is varied by subjecting the interface to step changes in normal pressure and the applied shear stress. The results of these experiments provide some new insights into the evolution of interfacial sliding resistance as a function of accumulated slip, slip velocity, interfacial normal pressures and temperatures.

  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. Successful Collaborative Software Projects for Medical Devices in an FDA Regulated Environment: Myth or Reality?

    Microsoft Academic Search

    Subita Sudershana; Abel Villca-Roque; Jonathan Baldanza

    2007-01-01

    The significance of executing a successful collaborative distributed software project in a regulated medical device industry is often recognized but such projects are never perfectly achieved. There expectations of standard software being delivered 'bug-free, on time and on budget'. In addition, FDA regulations impose a high standard on such medical device software by mandating the adherence to strict processes on

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

    PubMed

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

    2015-07-01

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

  13. Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies.

    PubMed

    Nelson, Lewis S; Loh, Meredith; Perrone, Jeanmarie

    2014-06-01

    The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www.fda.gov) were searched using the search terms "risk evaluation and mitigation strategy" (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood. PMID:24414251

  14. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

    Microsoft Academic Search

    Frank Sistare; Federico Goodsaid; Marisa Papaluca; Josef S Ozer; Craig P Webb; William Baer; Anthony Senagore; Matthew J Schipper; Jacky Vonderscher; Stefan Sultana; David L Gerhold; Jonathan A Phillips; Gérard Maurer; Kevin Carl; David Laurie; Ernie Harpur; Manisha Sonee; Daniela Ennulat; Dan Holder; Dina Andrews-Cleavenger; Yi-Zhong Gu; Karol L Thompson; Peter L Goering; Jean-Marc Vidal; Eric Abadie; Romaldas Maciulaitis; David Jacobson-Kram; Albert F Defelice; Elizabeth A Hausner; Melanie Blank; Aliza Thompson; Patricia Harlow; Douglas Throckmorton; Shen Xiao; Nancy Xu; William Taylor; Spiros Vamvakas; Bruno Flamion; Beatriz Silva Lima; Peter Kasper; Markku Pasanen; Krishna Prasad; Sean Troth; Denise Bounous; Denise Robinson-Gravatt; Graham Betton; Myrtle A Davis; Jackie Akunda; James Eric McDuffie; Laura Suter; Leslie Obert; Magalie Guffroy; Mark Pinches; Supriya Jayadev; Eric A Blomme; Sven A Beushausen; Valérie G Barlow; Nathaniel Collins; Jeff Waring; David Honor; Sandra Snook; Jinhe Lee; Phil Rossi; Elizabeth Walker; William Mattes; Frank Dieterle

    2010-01-01

    The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have

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

    Cancer.gov

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

  16. 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...

  17. FDA and the critical path to twenty-first-century medicine.

    PubMed

    Pitts, Peter J

    2008-10-01

    One of the most pressing issues that confronts the Food and Drug Administration (FDA) is learning how to better address and assist in medical product development. FDA needs to prepare today so the agency can efficiently evaluate the technologies of tomorrow. Clearly, this is an area that impacts not only health care consumers but also our economies and financial markets. If the FDA can be a more aggressive part of the solution, they can help not only ease some of the pressures that are driving up health care costs but also help all of us to maximize the value of medical innovations. The high cost of research and development is forcing many companies to make the short-term business decision to focus product development on those molecules that have a much higher potential to recoup expenditures. Unfortunately, this trumps attempts to develop potentially risky but breakthrough products for diseases affecting smaller populations, the orphan drugs. FDA's critical path initiative will enable innovative growth companies to better and more efficiently attack the steep hurdles facing them, allowing them to compete more effectively against the bigger, better-funded players in the market on a more level playing field. That means a real change in the risk/benefit equation for both the emerging growth companies and the public health. PMID:18840855

  18. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...confirmed by FDA for review as follows: (1) If the article of food is arriving...notice before the article of food is sent...confirmed for review with a reply...prior notice for review. (e) The...accompany any article of food...

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2008-01-01

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

  1. 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. Copyright © 2014 John Wiley & Sons, Ltd. PMID:25059655

  2. Pleistocene Suvero slide, Paola basin, southern Italy

    USGS Publications Warehouse

    Trincardi, F.; Normark, W.R.

    1989-01-01

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

  3. Rock Slide Risk Assessment: A Semi-Quantitative Approach

    Microsoft Academic Search

    H. S. B. Duzgun

    2009-01-01

    Rock slides can be better managed by systematic risk assessments. Any risk assessment methodology for rock slides involves identification of rock slide risk components, which are hazard, elements at risk and vulnerability. For a quantitative\\/semi-quantitative risk assessment for rock slides, a mathematical value the risk has to be computed and evaluated. The quantitative evaluation of risk for rock slides enables

  4. A strategy for the use of electronic records and electronic signatures in accordance with FDA ruling 21 CFR part 11

    Microsoft Academic Search

    Colm O Suilleabhain

    This paper seeks to identify strategies for achieving compliance with the food and drug association's (FDA) regulation 21 CFR (code of federal regulation) part 11 on electronic records and signatures and for realising the organizational benefits that can be obtained from the use of electronic records. The paper starts with a background chapter that provides an introduction to the FDA,

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

    PubMed Central

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

    2015-01-01

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

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

    ERIC Educational Resources Information Center

    Lott, Bruce

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

  7. CSc 155 Lecture Note Slides Foundations

    E-print Network

    Gordon, Scott

    CSc 155 Lecture Note Slides 3D Math Foundations CSc 155 Lecture Note Slides 3D Math Foundations 2 3-handed Coordinate System P (x,y,z) X Y Z Left-handed Coordinate System P (x,y,z) GLSL ­ vec4 GraphicsLib3D ­ Point3D #12;CSc 155 Lecture Note Slides 3D Math Foundations 3 Matrices Column-major form: A00 A10 A20 A30 A01

  8. From bench to FDA to bedside: US regulatory trends for new stem cell therapies.

    PubMed

    Knoepfler, Paul S

    2015-03-01

    The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as "The Valley of Death". This moniker seems appropriate because it is at this point, and in particular in the work that ensues after Phase 1, clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here. PMID:25489841

  9. Food and Drug Administration (FDA) Vaccines, Blood & Biologics

    NSDL National Science Digital Library

    On this site, visitors can learn about the regulations and standards for Vaccines, Blood & Biologics. The site is divided up into a number of broad areas, including Allergenics, Cellular and Gene Therapy Products, Tissue and TIssue Products, and Xenotransplantation. The right side of the page also presents handy current issues, including recalls and alerts, and approvals and clearances.

  10. 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)

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

    ERIC Educational Resources Information Center

    Brown, F. Dale; Mitchell, Thomas O.

    1980-01-01

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

  12. FDA & digital mammography: why has FDA required full field digital mammography systems to be regulated as potentially dangerous devices for more than 10 years?

    PubMed

    Nields, Morgan W

    2010-05-01

    Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience additional debacles similar to that of digital mammography where important technology has been withheld from millions of women for more than a decade. PMID:20380981

  13. 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).

  14. Creating Animation for Presentations

    Microsoft Academic Search

    Douglas Zongker

    2003-01-01

    Abstract: Creating Animation for Presentationsby Douglas ZongkerChair of Supervisory Committee:Professor David H. SalesinComputer Science & EngineeringIn recent years the use of computer-generated slides to accompany live presentation has becomeincreasingly common. There is a potential for using computer graphics to increase the effectivenessof this type of presentation. The hardware for generating and projecting complex scenes andanimation is in place, yet few

  15. 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

  16. 3D finite element modeling of sliding wear

    NASA Astrophysics Data System (ADS)

    Buentello Hernandez, Rodolfo G.

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

  17. DOE/FDA/EPA: Workshop on methylmercury and human health

    SciTech Connect

    Moskowitz, P.D.; Saroff, L.; Bolger, M.; Cicmanec, J.; Durkee, S. [eds.

    1994-12-31

    In the US the general population is exposed to methylmercury (MeHg) principally through the consumption of fish. There is continuing discussion about the sources of this form of mercury (Hg), the magnitudes and trends in exposures to consumers, and the significance of the sources and their contributions to human health. In response to these discussions, the US Department of Energy, the US Food and Drug Administration, and the US Environmental Protection Agency cosponsored a two-day workshop to discuss data and methods available for characterizing the risk to human health presented by MeHg. This workshop was attended by 45 individuals representing various Federal and state organizations and interested stakeholders. The agenda covered: Agency interests; probabilistic approach to risk assessment; emission sources; atmospheric transport; biogeochemical cycling; exposure assessment; health effects of MeHg; and research needs.

  18. The characterization of the Frank Slide deposit

    NASA Astrophysics Data System (ADS)

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

    2010-05-01

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

  19. How to do a 50-minute Class Presentation? ---Pitfalls Observed from Students' Presentations

    E-print Network

    Zhou, Gang

    them? Dry run with friends who are not familiar with your presentation Track the time Prepare signal from slides & oral signal from your mouth should coordinate for the same purpose 6 #12;6. Very dry specific title to give more information Anyway, title is the most eye-catching place in a slide · Do

  20. Sliding mode control experiments of uncertain dynamical systems with time delay

    NASA Astrophysics Data System (ADS)

    Qin, Zhi-Chang; Zhong, Shun; Sun, Jian-Qiao

    2013-12-01

    This article presents the simulation and experimental studies for the nonlinear time-delayed dynamical systems with uncertainties. A rotary flexible joint made by Quanser is chosen as the model system to investigate the method for sliding mode control design. We considered the geometric nonlinearity of the flexible joint consisting of two linear springs. The system is assumed to have constant delay time and uncertain parameters with known upper and lower bounds. We also design an optimal sliding surface for the sliding mode control. Simulations and experiments are carried out to demonstrate the utility of the control method. Finally, the results from the simulations and experiments are in excellent agreement.

  1. Type 2 diabetes mellitus and Invokana: an FDA approved drug.

    PubMed

    Akhtar, Nida

    2013-11-01

    Diabetes Mellitus is a chronic metabolic disease affecting wide range of people across the globe. In India the rate of subjects being suffered from diabetes is continuously increasing. So, the development of drugs for its effective treatment is essential. Thereby, various attempts have been made to discover newer drugs, to reduce the rate of anti diabetic occurrence. Anti-diabetic drugs were found to treat diabetes mellitus by lowering glucose levels in the blood. Both the use antidiabetic drugs as well as the changes in lifestyle and proper diet can significantly affect the severity of diabetes mellitus and also reduces the symptoms and occurrence of the disease. Researches in the past few years on diabetes mellitus showed that this disease is spreading at a very faster rate, thereby; various attempts have been made to treat it efficaciously. Development and approval of antidiabetic drugs is quite necessary. There are different classes of anti-diabetic drugs reported to treat diabetes. The objective of the present review is to explore Invokana as a newly approved antidiabetic drug for the effective treatment of type 2 diabetes. This review focuses mainly on the various aspects of diabetes mellitus and its treatment perspectives. From the various clinical studies done on Invokana, it was concluded that and Invokana was found to be very effective for the efficacious therapy of diabetes mellitus. PMID:24160357

  2. Slides

    E-print Network

    Joint work: Qi Feng, Xuejing Zhang

    2015-02-25

    Feb 26, 2015 ... elliptic condition:D.Nualart, B.Saussereau-2009;. Y.Hu,D.Nualart-2007. Hormander ... elliptic condition: T.Cass, C. Litterer, T.Lyons,2013. Hypoelliptic condition: T.Cass, P.Friz-2010, M.Hairer,. N.S.Pillai-2013, Y.Hu, T.Sindel- ...

  3. Slides

    E-print Network

    2012-06-18

    Jun 18, 2012 ... class, seismic and ultrasound imaging. ? m = 1: Doppler ultrasound ... g up to isometry. Known in 2D (Nachman, Lassas-Uhlmann), open in 3D. ... Interpret u and f as sections of trivial bundle E = SM ×C, get. D0. X u = ?f.

  4. Slide 1 Lecture 13 Amitabh Varshney

    E-print Network

    Jacobs, David

    ·1 Slide 1 Lecture 13 Copyright Amitabh Varshney Sampling and Aliasing · Sects. 4.17-18 in H Lecture 13 Copyright Amitabh Varshney Sampling Occurs when the sampling inherent in rendering does;·2 Slide 3 Lecture 13 Copyright Amitabh Varshney Some Aliasing Artifacts · Spatial: Jaggies, Moire

  5. CSc 165 Lecture Note Slides Event Handling

    E-print Network

    Gordon, Scott

    associated with input devices. SAGE supports these in its Input Manager. CSc 165 Lecture Note Slides Event as "event objects" · Associating listeners with types of event objects · Triggering the production of event objects when events occur · Handling those events in the event listeners CSc 165 Lecture Note Slides Event

  6. Ladder Slide Out - First Order Analysis

    Microsoft Academic Search

    Ralph L. Barnett; Dolores Gildin; S. Carl Uzgiris; Dennis B. Brickman; Kenneth L. d'Entremont; Michael A. Dilich; Christopher W. Ferrone; Suzanne A. Glowiak; John M. Goebelbecker; Crispin Hales; Gary M. Hutter; Brian D. King; Dror Kopernik; Woodrow Nelson; Peter J. Poczynok; R. Kevin; Harry R. Smith; William G. Switalski; Andrew H. Tudor; James R. Wingfield; Lucinda Fuller; Betty Bellows; Marna Forbes; Maureen Gilligan; Jan A. King; Norene Kramer; Florence Lasky; Neil Miller; Jackie Schwartz; Peter Warner; Glenn Werner; Mary A. Misiewicz; Christina Timmins; Lynn Wallace-Mills; Thomas E. Zabinski; Paula L. Barnett; Robert Kaplan; Bill Brown; Mario Visocnik; Charles Sinkovits; Patrick M. Brinckerhoff; John P. Bederka; Jr. Richard Gullickson; Diane K. Moshman; James T. O'Donnell; William D. Sheridan; Audrone M. Stake; Shelley Hamilton; Jeffery W. Abendshien; Leslie A. Savage; James T. Semrau; Theodore Liber

    1996-01-01

    One of the more important collapse modes for straight, combination, and extension ladders is base slide out; the top of the ladder slides down the support wall as the base slips away from it. Various fundamental models have been used to study this behavior. This paper revisits the analytical solutions associated with these models and describes their implications for the

  7. Uncovering Slide Coating Window with Theoretical Modeling

    Microsoft Academic Search

    Kristianto Tjiptowidjojo; Marcio S. Carvalho

    Slide coating is a method used for rapidly depositing multilayer of coating onto a moving substrate or web simultaneously. This method is commonly used in the manufacturing of photographic products, magnetic recording media, and optical films. Slide coating is a premetered coating method, in which the thickness of the coating is set by the liquid flow rate and web speed

  8. GELATIN SUBBED SLIDES (SOP-21) GELATIN SOLUTION

    E-print Network

    Kleinfeld, David

    GELATIN SUBBED SLIDES (SOP-21) GELATIN SOLUTION · Warm 1000 ml dH2O to 70° C (Do not heat water after adding gelatin!) · Add 2 g gelatin (270 Bloom) and stir until dissolved. · Add 0.4 g chomium staining dish with the gelatin solution. · Dip slide racks slowly into staining dish; bob them up and down

  9. Sliding control approach to underactuated multibody systems

    Microsoft Academic Search

    Hashem Ashrafiuon; R. Scott Erwin

    2004-01-01

    A robust control algorithm is proposed for stabilization and tracking control of underactuated multibody mechanical systems governed by nonlinear equations of motion. Sliding, or variable structure, control is a simple but robust nonlinear control approach that is capable of handling both disturbances and parameter uncertainties. We formulate the sliding control approach for general underactuated multibody systems, and define first order

  10. Coupled Masses: Pendulum on Sliding Support

    NSDL National Science Digital Library

    Wolfgang Christian

    A simple pendulum is attached to a mass which can slide freely on a horizontal frictionless surface. Predictions can be made about the motion of the system and what the graph of x positions of the pendulum bob and the sliding mass will look like as a function of time.

  11. 'Off-label' drug use: an FDA regulatory term, not a negative implication of its medical use.

    PubMed

    Meadows, W A; Hollowell, B D

    2008-01-01

    As physicians continue to prescribe more and more drugs, plaintiff's attorneys in the wake of tort reform are attempting to carve out or create informed consent cases based on the Food and Drug Administration's (FDA) labeling requirements and the doctors' communications with their patients as it relates to those requirements. The theory of tort litigation revolves around whether the doctor disclosed to his patient the fact that he prescribed a drug in an 'off-label' manner, or for a purpose not approved by the FDA's testing process. This article argues that the doctor's decision to inform the patient of the 'off-label' status of the prescription is not relevant to the physician's standard of care for an informed consent case. First, the FDA has specifically stated that its procedures and requirements have no effect on the practice of medicine and that the FDA does not prohibit doctors from prescribing drugs in an 'off-label' manner. Second, the FDA's approval of a drug is immaterial to the effectiveness in the drug's 'off-label' use. In fact, prescribing medication in an 'off-label' manner can constitute the standard of care in many cases. Third, a doctor's duty is to practice medicine and treat his patient, not inform the patient of the FDA's non-medically related labeling. Therefore, doctors should not be branded with the additional duty of disclosing non-pertinent information, such as the FDA's medically irrelevant distinction, to their patients. PMID:18004389

  12. 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

  13. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2008-03-01

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

  15. Acoustic evidence of a submarine slide in the deepest part of the Arctic, the Molloy Hole

    NASA Astrophysics Data System (ADS)

    Freire, Francis; Gyllencreutz, Richard; Jafri, Rooh Ullah; Jakobsson, Martin

    2014-08-01

    The western Svalbard continental margin contains thick sediment sequences with areas known to contain gas hydrates. Together with a dynamic tectonic environment, this makes the region prone to submarine slides. This paper presents results from geophysical mapping of the deepest part of the high Arctic environment, the Molloy Hole. The mapping includes multibeam bathymetry, acoustic backscatter and sub-bottom profiling. The geophysical data reveal seabed features indicative of sediment transport and larger-scale mass wasting. The large slide scar is here referred to as the Molloy Slide. It is located adjacent to the prominent Molloy Hole and Ridge system. The slide is estimated to have transported >65 km3 of sediments over the deep axial valley of the Molloy Ridge, and further into the Molloy Hole. A unique feature of this slide is that, although its run-out distance is relatively short (<5 km), it extends over an enormous vertical depth (>2,000 m) as a result of its position in a complex bathymetric setting. The slide was most likely triggered by seismic activity caused by seafloor spreading processes along the adjacent Molloy Ridge. However, gas-hydrate destabilization may also have played a role in the ensuing slide event.

  16. Optimal Control of a Nine-Level Class-D Audio Amplifier Using Sliding-Mode Quantization

    Microsoft Academic Search

    Shiang-Hwua Yu; Ming-Hung Tseng

    2011-01-01

    This paper presents an optimal control scheme for a multilevel inverter working for audio power amplification. The proposed control scheme comprises two loops of feedback around a sliding-mode quantizer. The double-loop feedback generates a continuous equivalent control signal, while the quantizer that operates in the sliding mode converts the equivalent control signal into a staircase voltage waveform used to drive

  17. Killing with kindness: why the FDA need not certify drugs used for execution safe and effective.

    PubMed

    Annas, G J

    1985-09-01

    In 1977, Texas and Oklahoma became the first states to legalize administration of the death penalty by lethal injection; by late 1985, 14 other states had followed suit. Opponents of the death penalty petitioned the Food and Drug Administration in 1980 to declare drugs specified for use in executions as "not approved," and to prevent their use for that purpose. When the FDA denied their request, the petitioners took legal action against the agency, eventually arguing their case before the U.S. Supreme Court, which ruled against them in Heckler v. Chaney (1985). Annas discusses the Court's action, which dealt only with the judicial reviewability under federal statute of the FDA's decision not to exercise its authority over the use of drugs in interstate commerce. He notes that, by dealing only with procedural issues, the Court avoided ruling on the death penalty itself. PMID:4025665

  18. Anti-D immunoglobulin therapy for pediatric ITP: before and after the FDA's black box warning.

    PubMed

    Thompson, Joel C; Klima, Jennifer; Despotovic, Jenny M; O'Brien, Sarah H

    2013-11-01

    In March 2010, the Food and Drug Administration (FDA) issued a black box warning for anti-D immunoglobulin (anti-D), an approved treatment for immune thrombocytopenia (ITP). It is unknown if and how clinical practice at U.S children's hospitals has since changed. We sought to describe inpatient anti-D usage, laboratory monitoring, and anti-D complications before and after the FDA warning. Using the Pediatric Health Information System, we collected data from 41 children's hospitals. There was a modest but statistically significant decrease in anti-D usage from pre-warning to post-warning. Severe complication rates were very low and did not change appreciably. PMID:23813881

  19. Signs of change or clash of symbols? FDA regulation of nutrient profile labeling.

    PubMed

    Lytton, Timothy D

    2010-01-01

    A new generation of food labels uses symbols and ratings on the front of packages and on supermarket shelves to indicate a product's nutritional value. Proponents of these new labels assert that they help consumers make healthier dietary choices. Critics contend that the new labels are confusing and misleading. This article argues that, with some minor reforms, the FDA's existing regulatory framework governing nutrient content claims on food labels is well suited to balance these competing considerations. With regard to the most novel and complex labels--those that rate the overall nutritional value of food products based on detailed algorithms--the article proposes that the FDA provide minimum standards that would prevent fraudulent or misleading claims while allowing for genuine experimentation and competition within the private sector that is likely to advance knowledge in the areas of nutrition and food labeling as a public health strategy. PMID:20862926

  20. Stanford University Special Considerations for the Oversight of Research GUI-26m Research Compliance Office Protocols in FDA-regulated Drug or Device Studies

    E-print Network

    Puglisi, Joseph

    Compliance Office Protocols in FDA-regulated Drug or Device Studies File:GUI01026 rev2 03/06 1 of 2 Considerations for the Oversight of Research GUI-26m Research Compliance Office Protocols in FDA-regulated Drug the investigation is discontinued and FDA is notified. [21 CFR §312.62] #12;Stanford University Special

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

    ERIC Educational Resources Information Center

    Oliver, Jason; Kowalczyk, Christine

    2013-01-01

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

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

    SciTech Connect

    Not Available

    1983-10-01

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

  3. FDA compliance program guidance manual. Section VI. Radiological health. Updates. Irregular repts

    SciTech Connect

    Not Available

    1980-01-01

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

  4. FDA compliance program guidance manual (FY 83). section VI. radiological health. updates. Irregular repts

    SciTech Connect

    Not Available

    1982-01-01

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

  5. FDA Compliance Program Guidance Manual. Section VI. Radiological health. Updates. Irregular repts

    SciTech Connect

    Not Available

    1981-01-01

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

  6. Application of respiration and FDA hydrolysis measurements for estimating microbial activity during composting processes

    Microsoft Academic Search

    Spyridon Ntougias; Constantinos Ehaliotis; Kalliope K. Papadopoulou; George Zervakis

    2006-01-01

    Olive-tree leaves (OL) were mixed with olive press cake (OPC) and extracted olive press cake (EPC) at 1:1 dw\\/dw ratios to\\u000a prepare two composting mixtures (OL+OPC and OL+EPC). Both CO2–C evolution and fluorescein diacetate (FDA) hydrolysis, determined as estimates of the microbial activity during composting,\\u000a were related to temperature fluctuations in the compost piles, showing greater values at the temperature peaks,

  7. Gas permeability, diffusivity, solubility, and aging characteristics of 6FDA-durene polyimide membranes

    Microsoft Academic Search

    Wen-Hui Lin; Tai-Shung Chung

    2001-01-01

    We have determined the intrinsic gas transport properties of He, H2, O2, N2, CH4, and CO2 for a 6FDA-durene polyimide as a function of pressure, temperature and aging time. The permeability coefficients of O2, N2, CH4, and CO2 decrease slightly with increasing pressure. The pressure-dependent diffusion coefficients and solubility coefficients are consistent with the dual-sorption model and partial immobilization. All

  8. FDA Drug Approval Summary: Azacitidine (5-azacytidine, Vidaza™) for Injectable Suspension

    Microsoft Academic Search

    EDVARDAS KAMINSKAS; ANN T. FARRELL; YONG-CHENG WANG; RAJESHWARI SRIDHARA; RICHARD PAZDUR

    On May 19, 2004, azacitidine (5-azacytidine; Vidaza ™ ; Pharmion Corporation, Boulder, CO, http:\\/\\/www. pharmion.com) for injectable suspension received regu- lar approval by the U.S. Food and Drug Administration (FDA) for the treatment of all subtypes of myelodys- plastic syndrome (MDS). This report summarizes the basis for this approval. Effectiveness was demonstrated in one randomized, controlled trial comparing azaciti- dine

  9. Minimum-time spacecraft maneuver using sliding-mode control [rapid communication

    NASA Astrophysics Data System (ADS)

    Jan, Y. W.; Chiou, J. C.

    2004-01-01

    The purpose of this paper is to present a sliding mode control method that can be used to perform a spacecraft large angle maneuver with minimum time. An algorithm of minimum-time SMC is developed to provide the robust tracking control. The simulation results are compared with previous developed control schemes, eigenaxis quaternion regulator, to demonstrate the superiority of the proposed sliding mode control algorithm.

  10. Sliding mode control for trajectory tracking of mobile robot in the RFID sensor space

    Microsoft Academic Search

    Jun Ho Lee; Cong Lin; Hoon Lim; Jang Myung Lee

    2009-01-01

    This paper presents a sliding mode control method for wheeled mobile robots. Because of the nonlinear and nonholonomic properties,\\u000a it is difficult to establish an appropriate model of the mobile robot system for trajectory tracking. A robust control law\\u000a which is called sliding mode control is proposed for asymptotically stabilizing the mobile robot to a desired trajectory.\\u000a The posture of

  11. Model-Based Fault Diagnosis Using Sliding Mode Observers to Takagi-Sugeno Fuzzy Model

    Microsoft Academic Search

    B. Castillo-Toledo; J. Anzurez-Marin

    2005-01-01

    In this paper, we present some results obtained from the application of a class of sliding mode observers to the model-based fault diagnosis problem in non-linear dynamic systems. A Takagi-Sugeno fuzzy model is used to describe the system and then sliding mode observers are designed to estimate the system state vector, from this the diagnostic signal-residual is generated by the

  12. Fault Detection and Isolation Problem: Sliding Mode Fuzzy Observers and Linear Integer Programming

    Microsoft Academic Search

    Juan Anzurez-Marin; Bernardino Castillo Toledo; Elisa Espinosa-Juárez

    2008-01-01

    In this paper, we present some results obtained from the application of a class of sliding mode observers to the model-based fault diagnosis problem in non-linear dynamic systems. A Takagi-Sugeno fuzzy model is used to describe the system and then sliding mode observers are designed to estimate the system state vector, from this the diagnostic signal-residual, is generated by the

  13. Role of Surface Texture, Roughness, and Hardness on Friction During Unidirectional Sliding

    Microsoft Academic Search

    Pradeep L. MenezesKishoreSatish; Kishore; Satish V. Kailas; Michael R. Lovell

    2011-01-01

    In the present investigation, experiments were conducted by unidirectional sliding of pins made of FCC metals (Pb, Al, and\\u000a Cu) with significantly different hardness values against the steel plates of various surface textures and roughness using\\u000a an inclined pin-on-plate sliding apparatus in ambient conditions under both the dry and lubricated conditions. For a given\\u000a material pair, it was observed that

  14. Micro-Sliding in High-Speed Aircraft Engine Ball Bearings

    Microsoft Academic Search

    Peter Gloeckner; Franz-Josef Ebert

    2010-01-01

    Micro-sliding within the contact ellipse of high-speed ball bearings is a tribological phenomenon that occurs in large, high-speed aircraft turbine engine ball bearings that should be taken into consideration in the design of high-speed ball bearings. This article presents the phenomenon of micro-sliding within the ball bearing contact zone, the parameters that impact its generation, and the extent and the

  15. Implementation of robust wavelet-neural-network sliding-mode control for induction servo motor drive

    Microsoft Academic Search

    Rong-Jong Wai; Jia-Ming Chang

    2003-01-01

    This paper presents the design and properties of a robust wavelet-neural-network sliding-mode control (RWSC) system for an indirect field-oriented induction servo motor drive to track periodic commands. First, a total sliding-mode control (TSC) system with an integral-operation-switching surface, which is insensitive to uncertainties in the whole control process, is introduced. In the TSC system the controlled system has a total

  16. Slides: Communicating with Today's Generation

    NSDL National Science Digital Library

    These webinar slides are from the webinar that was recorded 12/12/08. They have been turned into a PDF file. Are your classroom lectures designed to teach the new breed of student? One raised on a steady diet of video games, electronic gadgets and the Internet. Confused by the right use of Wikis, Blogs, IM and Podcasts for the classroom? Ever wonder how to communicate with the ever connected but seamingly isolated new generation of students? Then this webinar is for you. Based on the hot selling book "Gadgets, Games and Gizmos for Learning." Dr. Karl M. Kapp will explain how and why the incoming "gamer generation" requires major changes in instructional delivery methods and techniques. He will also explain steps and tips for reaching this new generation through the use of their own "New Media."

  17. Sliding mode control of flexible spacecraft under disturbance torque

    Microsoft Academic Search

    Ashok Iyer; S. N. Singh

    1988-01-01

    The authors present a control system design for large-angle rotational maneuvers of a spacecraft-beam-tip body (an antenna or a reflector) configuration. It is assumed that an unknown but bounded disturbance torque is acting on the spacecraft. A sliding mode attitude control law is derived for the slewing of the space vehicle. This slewing control law requires only attitude error and

  18. Conduction Noise in Sliding Charge-Density Waves

    Microsoft Academic Search

    Gordon Lee Link

    1990-01-01

    The conduction noise from sliding charge-density waves (CDWs) is studied in NbSe_3 and K_{0.3}MoO _3 (blue bronze). A statistical analysis of the fluctuations in the noise is presented: the probability distributions of the fluctuating spectral components, the power spectra of these fluctuations (i.e. the second spectra), and their correlation functions all indicate that the ac signal accompanying CDW conduction is

  19. Micropitting Modelling in Rolling - Sliding Contacts: Application to Rolling Bearings

    Microsoft Academic Search

    G. E. Morales-Espejel; V. Brizmer

    2011-01-01

    In this article an engineering approach is described to model micropitting in rolling-sliding, heavily loaded lubricated contacts. The competitive mechanism between surface fatigue and mild wear is captured in the present approach as well as the effects of deterministic surface micro-geometry (e.g. roughness). The fatigue model is based on the Dang Van fatigue criterion and the mild wear model uses

  20. Adaptive backstepping sliding mode control for feedforward uncertain systems

    Microsoft Academic Search

    Ali J. Koshkouei; Keith J. Burnham

    2011-01-01

    Output tracking backstepping sliding mode control for feedforward uncertain systems is considered in this article. Feedforward systems are not usually transformable to the parametric semi-strict feedback form, and they may include unmatched uncertainties consisting of disturbances and unmodelled dynamics terms. The backstepping method presented in this article, even without uncertainties differs from that of Ríos-Bolívar and Zinober [Ríos-Bolívar, M. and

  1. Whole slide imaging for educational purposes

    PubMed Central

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

    2012-01-01

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

  2. Implementation of a Sliding-Mode Controller With an Integral Function and Fuzzy Gain Value for the Electrical Drive With an Elastic Joint

    Microsoft Academic Search

    Marcin Kaminski; Krzysztof Szabat

    2010-01-01

    This paper presents a modified sliding-mode structure implemented for the speed control of a two-mass drive. A characteristic feature of the presented control method is the higher rank of the switching function caused by the application of an integral element (sliding mode with an integral function control). The proposed control system is a combination of a sliding-mode controller and a

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

    E-print Network

    Acemoglu, Daron

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over ...

  4. FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs

    MedlinePLUS

    ... Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to ... and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs Search the Consumer Updates Section Get this high- ...

  5. 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

    ...FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee...availability of a guidance for industry entitled ``Implementation...availability of a guidance for industry entitled ``Implementation...Page 62074

  6. Lubricant dynamics in sliding and flying

    NASA Astrophysics Data System (ADS)

    Novotny, V. J.; Baldwinson, M. A.

    1991-11-01

    The dynamics of molecularly thin liquid lubricant films in sliding and flying experiments is studied principally by scanning microellipsometry and complemented with both scanning x-ray photoelectron spectroscopy and infrared spectroscopy. Microellipsometric profiling of lubricant thickness is performed in situ, either dynamically or statically on films ranging from 1 to 10 nm. The removal of liquid polyperfluoroether lubricants from sliding and flying tracks, which includes the displacement and loss depends on film thickness, molecular weight, and chemical structure. In flying and sliding, the lubricant removal rate from monolayer films is significantly slower than from multilayer films. In flying, lubricant displacement and loss increase with a decrease in molecular weight.

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

    ERIC Educational Resources Information Center

    Still, Steven

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

  8. Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice

    Microsoft Academic Search

    John S. Esterly; Emily Steadman; Marc H. Scheetz

    2011-01-01

    Objective In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered\\u000a to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the\\u000a greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify\\u000a the

  9. 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.

  10. Simple method for determining frictional sliding resistance and frictional energy dissipation in layered ceramics

    SciTech Connect

    Kovar, D.; Thouless, M. [Univ. of Michigan, Ann Arbor, MI (United States)

    1997-03-01

    A method is presented for measuring the frictional sliding resistance between cracked laminae in a layered ceramic. The first step in the test involves using a wedge to completely crack a weak interface along the length of the specimen. The cracked specimen is then loaded in three-point bending, and the load-deflection response is monitored. A deviation from linearity is observed when the load is sufficiently high for sliding to occur between the upper and lower halves of the specimen. The load at which this nonlinearity is first observed can be related to the interfacial sliding resistance. A model is then developed to relate the energy absorbed during a load-unload cycle to the frictional sliding resistance. The analysis is verified using a model system made from steel, and a ceramic composite made from silicon nitride and boron nitride.

  11. 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

  12. Creating a Poster from a PowerPoint Presentation

    E-print Network

    Dyer, Bill

    Creating a Poster from a PowerPoint Presentation Creating a Poster from a PowerPoint Presentation #12;Determine Size of PosterDetermine Size of Poster Organization's rules Size the software dimension of the poster can be no more than 41" #12;Number of Slides NeededNumber of Slides Needed Once size

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

    PubMed

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

    2013-03-01

    In this paper, the terminal sliding mode tracking control is proposed for the uncertain single-input and single-output (SISO) nonlinear system with unknown external disturbance. For the unmeasured disturbance of nonlinear systems, terminal sliding mode disturbance observer is presented. The developed disturbance observer can guarantee the disturbance approximation error to converge to zero in the finite time. Based on the output of designed disturbance observer, the terminal sliding mode tracking control is presented for uncertain SISO nonlinear systems. Subsequently, terminal sliding mode tracking control is developed using disturbance observer technique for the uncertain SISO nonlinear system with control singularity and unknown non-symmetric input saturation. The effects of the control singularity and unknown input saturation are combined with the external disturbance which is approximated using the disturbance observer. Under the proposed terminal sliding mode tracking control techniques, the finite time convergence of all closed-loop signals are guaranteed via Lyapunov analysis. Numerical simulation results are given to illustrate the effectiveness of the proposed terminal sliding mode tracking control. PMID:23127620

  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. Determination of near-surface plastic deformation in sliding contacts

    NASA Technical Reports Server (NTRS)

    Kennedy, F. E., Jr.; Grotelueschen, L. P.

    1984-01-01

    It is pointed out that substantial plastic deformation occurs on and near the contact surfaces, when two solid bodies slide against each other without lubrication. It has been found that this deformation plays an important role in the tribological behavior of the sliding contact. The present investigation has the objective to develop an analytical model to predict the near-surface plastic deformation resulting from a single pass of one metallic surface over another. A finite element viscoplasticity program was written relating velocities to forces in a two-dimensional domain. The program was employed in the study of plastic deformation during a single pass of a hardened tool steel slider over a copper rub specimen. It was found that essentially the only material set in motion by the slider was directly under the contact zone. The agreement between values obtained in the analysis and experimental data is reasonably good.

  16. 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.

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

    SciTech Connect

    Geng, Yongliang; Zhu, Chunao; Zhang, Bo, E-mail: bo.zhang@hfut.edu.cn [School of Material Science and Engineering, Hefei University of Technology, Hefei 230009 (China) [School of Material Science and Engineering, Hefei University of Technology, Hefei 230009 (China); Anhui Provincial Key Lab of Advanced Functional Materials and Devices, Hefei University of Technology, Hefei 230009 (China)

    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.

  18. Enhancing classroom lectures with digital sliding blackboards

    Microsoft Academic Search

    Guido Rößling; Christoph Trompler; Max Mühlhäuser; Susanne Köbler; Susanne Wolf

    2004-01-01

    Traditional blackboard-based lectures provide context on the sliding blackboards. Modern lectures incorporating video projectors typically do not provide this context. We describe a project that combines both approaches to provide context for \\

  19. 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.

  20. Magic Lantern Slides Collection from Japan

    NSDL National Science Digital Library

    The University of Hawaii at Manoa (UHM) has a collection of approximately 1,500 magic lantern slides in its Japan Collection, which it has digitized with the permission of the Japan Foundation. The magic lantern was the precursor to the modern slide projector, and was extremely popular in Europe and Asia in the 1800s, with people going from towns to villages doing public shows. The slides featured on the UHM website are those that were produced and distributed by KBS, a group that was the predecessor of the Japan Foundation. To view the collection, you can browse alphabetically by title, category (from alcohol to fan making to Western clothes), and by slides with recent comments made about them. Visitors to the website shouldn't leave the site without browsing under the "University" category. With few exceptions, all the buildings are Western in style, and reminiscent of many U.S. colleges with their columns, stone, and tendency to sprawl.

  1. Using a Slide in Beef Cattle Marketing 

    E-print Network

    Machen, Richard V.; Gill, Ronald J.

    1998-08-21

    Selling cattle in advance of delivery requires the seller to estimate the future weight of the cattle. The sale price usually must be adjusted because delivery weights differ from estimated weights. This publication explains how to use an "up slide...

  2. Fuzzy sliding-mode control for a Mini-UAV

    Microsoft Academic Search

    Fu-Kuang Yeh; Ching-Mu Chen; Jian-Ji Huang

    2010-01-01

    This work addresses a fuzzy sliding-mode controller, which is mainly composed of the sliding mode controller and the fuzzy inference mechanism, for a mini unmanned air vehicle (UAV) with propellers to follow the predetermined trajectory. In this paper, a sliding-mode controller with a sliding surface is designed. And a fuzzy sliding-mode controller is proposed, such that a simple fuzzy inference

  3. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

    PubMed Central

    2014-01-01

    Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

  4. A Sliding Window Filter for Incremental SLAM

    Microsoft Academic Search

    Gabe Sibley; Larry Matthies; Gaurav Sukhatme

    This work develops a sliding window filter for incremental simultaneous localization and mapping (SLAM) that focuses computational\\u000a resources on accurately estimating the immediate spatial surroundings using a sliding time window of the most recent sensor\\u000a measurements. Ideally, we would like a constant time algorithm that closely approximates the all-time maximum-likelihood estimate\\u000a as well as the minimum variance Cramer Rao lower

  5. CSc 165 Lecture Note Slides Game Engines

    E-print Network

    Gordon, Scott

    (); + abstract void setGameOver(boolean isOver); + abstract boolean isGameOver(); 9 SomeGame > sage.app.AbstractGame>> AbstractGame - gameWorld, displaySystem, inputMgr, gameOver sage.app.BaseGame Implementations providedCSc 165 Lecture Note Slides Game Engines CSc 165 Lecture Note Slides Game Engines 2 Basic Game

  6. Paper Quilts: Exploring Flips and Slides

    NSDL National Science Digital Library

    Illuminations National Council of Teachers of Mathematics

    2009-07-07

    "Students explore the geometric transformations of reflection and translation. Students create a design, then, using flips and slides, make a four-part paper "mini-quilt" using that design as the basis. While the formal terms are reflection and translation, the more informal terms slide and flip are used at this stage. The experience focuses students’ attention on the changes these geometric transformations make in a student-designed quilt square." (from Illuminations, NCTM)

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

    NASA Astrophysics Data System (ADS)

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

    2010-12-01

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

  8. Design and Simulation of Guidance Law with Angular Constraint Based on Non-singular Terminal Sliding Mode

    NASA Astrophysics Data System (ADS)

    MengXiuyun, SongQiaozhen

    According to the characteristics of the guided bomb, a guidance law with angular constraint and robustness is always needed. The paper proposed a guidance law based on non-singular terminal sliding mode (NTSM). In the non-singular Terminal sliding mode control, the tracking error on the sliding surface can converge to zero in a finite time, so a nonlinear term was introduced into the design of the terminal guidance law to substitute the traditional linear sliding mode. In addition, considering the measurement error and the external interference as disturbance with known boundary and making an adaptive estimation to extremes in real time, a non-singular terminal sliding mode guidance law was presented. Controlled by TSMG, the rate of the line-of-sight (LOS) angle between bomb and target can converge quickly, and high guidance precision of bomb in large range airspace of flight condition can be obtained. The simulation results confirm the efficiency and availability of the guidance law.

  9. 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

  10. FDA Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Base Section (FY-92). Manual

    SciTech Connect

    Not Available

    1992-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  11. FDA Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Base section (FY91). Manual

    SciTech Connect

    Not Available

    1990-01-24

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

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

    PubMed

    1995-01-01

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

  13. Quality standards and certification requirements for mammography facilities--FDA. Interim rule with request for comments.

    PubMed

    1993-12-21

    The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (the MQSA), which requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This rule establishes requirements for certification of mammography facilities, including quality standards for mammography. This action is being taken to assure safe, accurate, and reliable mammography on a nationwide basis. The agency requests comments on the contents of this document. PMID:10131225

  14. Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors

    NSDL National Science Digital Library

    Released online by the Food and Drug Administration (FDA) on September 7, this 59-page report "establishes a baseline to measure how effective industry and regulatory efforts are in changing behaviors and practices that directly relate to food-borne illness in the retail food industry." Based on data collected from close to 900 institutional food service establishments, restaurants, and retail food stores, the report finds that three areas deserve special attention: improper holding times and temperatures, contaminated equipment, and poor personal hygiene. The full text of the report is available in HTML and .pdf formats.

  15. 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…

  16. A new numerical calculation method for the characteristics of hydrostatic slide

    NASA Astrophysics Data System (ADS)

    Hou, Guoan; Sun, Tao; Zhou, Jingbo; Qi, Enbing

    2012-10-01

    In the design and manufacture of the ultra-precision machine tools, hydrostatic slides have been applied frequently, in the state-of-the-art technology. They can provide extremely smooth and accurate motion and positioning. At design stage, the carrying capacity and the stiffness of hydrostatic slide is an important value. But, the traditional calculation method of slide stiffness used in engineering is an approximate solution, the accuracy is low. In this paper, finding an accurate calculation method of slide stiffness is present, to improve modeling accuracy. Reynolds equation is the basic equation of calculating performance of hydrostatic slide, oil film pressure distribution can be obtained by solving the Reynolds equation. But Reynolds equation is a second-order partial differential equations, it is difficult to directly solve the equation using analytic methods. Therefore, a discrete model is developed to solve the problem. A method that has been widely used is finite element analysis (FEA). Matlab PDE Toolbox provides a convenient way to solving the partial differential equations based the FEA. But it can only directly solve the partial differential equations with standard form. It is discussed how to transform the Reynolds equation into elliptic partial differential equation with standard form. Then combined with the specific boundary conditions, obtain the oil film pressure distribution through Matlab PDE toolbox, and then write program to achieve high-precision calculation of carrying capacity and stiffness of the slide.

  17. 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

  18. A Theoretical Development on Lubrication Mechanism at Thrust Slide-Bearing of Scroll Compressors

    NASA Astrophysics Data System (ADS)

    Oku, Tatsuya; Ishii, Noriaki; Anami, Keiko; Sawai, Kiyoshi; Morimoto, Takashi; Hiwata, Akira

    This study presents a theoretical development of excellent lubrication at the thrust slide-bearing of scroll compressors, caused by a wedge formation due to elastic deformation of the thrust plate at its periphery. In theoretical calculations, the average Reynolds equation by Patir & Cheng for rough sliding surfaces of the thrust slide-bearing was applied to analyze the fluid lubrication, while the solid contact theory by Greenwood & Williamson was applied to analyze the plastic and elastic contacts between the orbiting and fixed thrust plates. With the FEM-calculated wedge angle between the sliding surfaces, the oil film pressure, the solid contact force, the fluid frictional force and the solid shearing drag force were calculated to determine the resultant friction coefficient at the thrust slide-bearing. As a result, it was shown that the theoretical results have a good agreement with the lubrication test results, thus unveiling the essential contents of excellent fluid lubrication at the thrust slide-bearing, caused by the wedge formation due to large thrust loads.

  19. Sliding friction in compressed metals at high velocities

    SciTech Connect

    Hammerberg, J.E.; Holian, B.L.; Zhou, S.J.

    1996-09-01

    The properties of sliding metal interfaces under dynamic loading conditions are poorly known. For regimes of sliding speeds of order 0.1 the transverse sound speed and pressures of order shock pressures in metals, the following are essentially open questions from both a theoretical and experimental perspective: the velocity dependence of the tangential force, the nature of surface and subsurface micro structure and dislocation structure and evolution. Experimentally, there has been some recent progress in pressure-shear geometries by Prakash and Clifton for elastic materials. Theoretically, Sokoloff has treated a simplified model for which an inverse velocity dependence for g, the coefficient of sliding friction, has been predicted. In lieu of experimental work and as an incentive to perform relevant experiments it is of interest to perform numerical experiments. Of particular relevance are molecular dynamics (MD) experiments for materials with well characterized density dependent interatomic interaction potentials. For ductile metals (e.g., copper, nickel, aluminum), such potentials exist and are capable of reproducing equations of state and defect properties have shown. We shall present here the results of a series of atomistic simulations for copper-copper interfaces in a two dimensional geometry, focusing mainly on the density and velocity dependence of the coefficient of friction.

  20. 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.

  1. An FDA bioinformatics tool for microbial genomics research on molecular characterization of bacterial foodborne pathogens using microarrays

    PubMed Central

    2010-01-01

    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 a genomics tool, ArrayTrackTM, which provides extensive functionalities to manage, analyze, and interpret genomic data for mammalian species. ArrayTrackTM has been widely adopted by the research community and used for pharmacogenomics data review in the FDA’s Voluntary Genomics Data Submission program. Results ArrayTrackTM has been extended to manage and analyze genomics data from bacterial pathogens of human, animal, and food origin. It was populated with bioinformatics data from public databases such as NCBI, Swiss-Prot, KEGG Pathway, and Gene Ontology to facilitate pathogen detection and characterization. ArrayTrackTM’s data processing and visualization tools were enhanced with analysis capabilities designed specifically for microbial genomics including flag-based hierarchical clustering analysis (HCA), flag concordance heat maps, and mixed scatter plots. These specific functionalities were evaluated on data generated from a custom Affymetrix array (FDA-ECSG) previously developed within the FDA. The FDA-ECSG array represents 32 complete genomes of Escherichia coli and Shigella. The new functions were also used to analyze microarray data focusing on antimicrobial resistance genes from Salmonella isolates in a poultry production environment using a universal antimicrobial resistance microarray developed by the United States Department of Agriculture (USDA). Conclusion The application of ArrayTrackTM to different microarray platforms demonstrates its utility in microbial genomics research, and thus will improve the capabilities of the FDA to rapidly identify foodborne bacteria and their genetic traits (e.g., antimicrobial resistance, virulence, etc.) during outbreak investigations. ArrayTrackTM is free to use and available to public, private, and academic researchers at http://www.fda.gov/ArrayTrack. PMID:20946615

  2. 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.

  3. DEFORMATION AND FAILURE CAUSED BY GRAIN BOUNDARY SLIDING AND BRITTLE CRACKING

    E-print Network

    Evans, Anthony G.

    2013-01-01

    DEFORMATION AND FAILURE CAUSED BY GRAIN BOUNDARY SLIDING AND BRITTLEDEFORMATION AND FAILURE CAUSED BY GRAIN BOUNDARY SLIDING AND BRITTLEDEFORMATION AND FAILURE CAUSED BY GRAIN BOUNDARY SLIDING AND BRITTLE

  4. Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy.

    PubMed

    Vacchelli, Erika; Galluzzi, Lorenzo; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Zitvogel, Laurence; Kroemer, Guido

    2012-09-01

    Toll-like receptors (TLRs) have first been characterized for their capacity to detect conserved microbial components like lipopolysaccharide (LPS) and double-stranded RNA, resulting in the elicitation of potent (innate) immune responses against invading pathogens. More recently, TLRs have also been shown to promote the activation of the cognate immune system against cancer cells. Today, only three TLR agonists are approved by FDA for use in humans: the bacillus Calmette-Guérin (BCG), monophosphoryl lipid A (MPL) and imiquimod. BCG (an attenuated strain of Mycobacterium bovis) is mainly used as a vaccine against tuberculosis, but also for the immunotherapy of in situ bladder carcinoma. MPL (derived from the LPS of Salmonella minnesota) is included in the formulation of Cervarix®, a vaccine against human papillomavirus-16 and -18. Imiquimod (a synthetic imidazoquinoline) is routinely employed for actinic keratosis, superficial basal cell carcinoma, and external genital warts (condylomata acuminata). In this Trial Watch, we will summarize the results of recently completed clinical trials and discuss the progress of ongoing studies that have evaluated/are evaluating FDA-approved TLR agonists as off-label medications for cancer therapy. PMID:23162757

  5. FDA News Release: Approval of Irradiation of Meat for Pathogen Control

    NSDL National Science Digital Library

    United States. Food and Drug Administration.

    1997-01-01

    Previously approved for use on poultry and fruits and vegetables in the US, irradiation can kill disease-causing bacteria like Salmonella and Escherichia coli 0157:H7 (discussed in the Scout Report for Science and Engineering's In the News section, September 17, 1997), and molds and funguses that cause rot. With recent US Food and Drug Administration (FDA) approval, irradiation can now be used to process red meat (e.g., beef, pork, lamb, and byproducts). The process involves exposing food to a source of radiation such as gamma rays from radioactive cobalt 60, cesium 137, or x-rays. No radioactive material is added to the product, and the technique is routinely used on grains and spices, as well as for sterilizing disposable medical devices. In spite of a number of tests conducted over the last 30 years substantiating its safety, irradiation has not gained widespread public acceptance in the US. This is largely due to the public's general fear of processes utilizing radiation. Supporters of the technology claim that it will virtually eliminate food-borne illness in the US, while skeptics feel that technology such as steam treatment can accomplish adequate sterilization without the purported risks and public concern associated with irradiation. The US Food and Drug Administration (FDA) News Release contains the Agency's brief statement outlining its policy.

  6. A comparison of homopolymer and block copolymer structure in 6FDA-based polyimides.

    PubMed

    Tanis, I; Brown, D; Neyertz, S J; Heck, R; Mercier, R

    2014-11-14

    Two homopolyimides and the corresponding block copolyimide, all based on the 4,4'-(hexafluoroisopropylidene)diphthalic dianhydride (6FDA), have been synthesized and fully atomistic models have been studied using molecular dynamics (MD) simulation. The respective diamines were 1,3-phenylenediamine (mPDA) and 2,3,5,6-tetramethyl-1,4-phenylenediamine (durene). These polyimides are potential candidates for gas separation applications. The synthesized polymers were processed as dense flat membranes. The effects of diamine structure were investigated at the molecular level and an attempt to compare the structural features of homo- and block copolyimides was made. Amorphous models were generated using a hybrid pivot Monte Carlo-MD sampling preparation technique. Average model densities were validated against experimental measurements on the dense films. Cohesive energies, Hildebrand solubility parameters, conformational characteristics, intermolecular interactions and available void spaces were analysed for each system. The durene diamine was found to hinder stacking and increase the available space. This is associated with the steric effect of the methyl substituents. In general, 6FDA-mPDA/durene exhibits an intermediate behaviour with respect to its base polyimides. For most of the examined properties, the differences between different size simulated systems were minor with the exception of the free volume distribution. PMID:25247609

  7. 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

  8. 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.

  9. NEMD simulations for ductile metal sliding

    SciTech Connect

    Hammerberg, James E [Los Alamos National Laboratory; Germann, Timothy C [Los Alamos National Laboratory; Ravelo, Ramon J [Los Alamos National Laboratory; Holian, Brad L [Los Alamos National Laboratory

    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.

  10. Experimental Testing of Glacier Sliding Laws

    NASA Astrophysics Data System (ADS)

    Zoet, L.; Iverson, N. R.

    2013-12-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2014-05-01

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

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

    PubMed

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

    2015-02-01

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

  13. NASA SMD E/PO Community Addresses the needs of the Higher Ed Community: Introducing Slide sets for the Introductory Earth and Space Science Instructor

    NASA Astrophysics Data System (ADS)

    Buxner, S.; Meinke, B. K.; Brain, D.; Schneider, N. M.; Schultz, G. R.; Smith, D. A.; Grier, J.; Shipp, S. S.

    2014-12-01

    The NASA Science Mission Directorate (SMD) Science Education and Public Outreach (E/PO) community and Forums work together to bring the cutting-edge discoveries of NASA Astrophysics and Planetary Science missions to the introductory astronomy college classroom. These mission- and grant-based E/PO programs are uniquely poised to foster collaboration between scientists with content expertise and educators with pedagogy expertise. We present two new opportunities for college instructors to bring the latest NASA discoveries in Space Science into their classrooms. The NASA Science Mission Directorate (SMD) Astrophysics Education and Public Outreach Forum is coordinating the development of a pilot series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The "Astro 101 slide sets" are presentations 5-7 slides in length on a new development or discovery from a NASA Astrophysics mission relevant to topics in introductory astronomy courses. We intend for these slide sets to help Astronomy 101 instructors include new developments (discoveries not yet in their textbooks) into the broader context of the course. In a similar effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division of Planetary Sciences (DPS) has developed the Discovery slide sets, which are 3-slide presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides which cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and sets are available in Farsi and Spanish. The NASA SMD Planetary Science Forum has recently partnered with the DPS to continue producing the Discovery slides and connect them to NASA mission science.

  14. Exit Presentation -- Maintaining Balance

    NASA Technical Reports Server (NTRS)

    Heap, Erin

    2010-01-01

    This slide presentation reviews the projects which the author engaged in during an internship at Johnson Space Center. Project 1 was involved with Stochastic Resonance (SR). Stochastic resonance is a phenomenon in which the response of a non-linear system to a weak input signal is optimized by the presence of a particular non-zero level of noise. The goal of this project was to develop a countermeasure for sensorimotor disturbances that are experienced after long duration space flight. The second project was a pilot study that was to examine how adaptation to a novel functional task was affected by postural disturbance.

  15. Dynamical frictional force of nanoscale sliding

    NASA Astrophysics Data System (ADS)

    Inoue, Daisuke; Machida, Shingo; Taniguchi, Junko; Suzuki, Masaru; Ishikawa, Makoto; Miura, Kouji

    2012-09-01

    We measured the dynamical frictional force acting on highly oriented pyrolytic graphite and C60 substrates by a sliding Si3N4 tip as a function of sliding distance using the probe-tip-quartz-crystal-resonator technique. It was found that the dynamical frictional force undergoes a drastic change when the oscillation amplitude is approximately the lattice constant of each substrate: For a small case, it is directly proportional to the amplitude, while for a large case, it does not depend on the amplitude. The observed behavior is qualitatively understood by a simple one-dimensional Tomlinson model.

  16. Dry sliding wear behavior of magnesium alloys

    Microsoft Academic Search

    J. An; R. G. Li; Y. Lu; C. M. Chen; Y. Xu; X. Chen; L. M. Wang

    2008-01-01

    Dry sliding tests were performed on as-cast magnesium alloys Mg97Zn1Y2 and AZ91 using a pin-on-disc configuration. Coefficients of friction and wear rates were measured within a load range of 20–380 and 20–240N at a sliding velocity of 0.785m\\/s. X-ray differactometer, scanning electron microscopy, tensile testing machine were used to characterize the microstructures and mechanical properties of Mg97Zn1Y2 alloy and AZ91

  17. Kinetic Monte Carlo theory of sliding friction

    NASA Astrophysics Data System (ADS)

    Furlong, Octavio Javier; Manzi, Sergio Javier; Pereyra, Victor Daniel; Bustos, Victor; Tysoe, Wilfred T.

    2009-10-01

    The sliding friction as a function of scanning velocity at the nanometer scale was simulated based on a modified one-dimensional Tomlinson model. Monte Carlo theory was exploited to describe the thermally activated hopping of the contact atoms, where both backward and forward jumps were allowed to occur. By comparing with the Monte Carlo results, improvements to current semiempirical solutions [E. Riedo , Phys. Rev. Lett. 91, 084502 (2003)] were made. Finally, experimental results of sliding friction on a NaCl(100) as a function of normal load and scanning velocity [E. Gnecco , Phys. Rev. Lett. 84, 1172 (2000)] where successfully simulated.

  18. A Sliding Memory Plane Array Processor

    Microsoft Academic Search

    Myung Hoon Sunwoo; J. K. Aggarwal

    1993-01-01

    A mesh-connected single-input multiple-data (SIMD) architecture called a sliding memory plane (SliM) array processor is proposed. Differing from existing mesh-connected SIMD architectures, SliM has several salient features such as a sliding memory plane that provides inter-PE communication during computation. Two I\\/O planes provide an I\\/O overlapping capability. Thus, inter-PE communication and I\\/O overhead can be overlapped with computation. Inter-PE communication

  19. Slide Set - Unit 8 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  20. Slide Set - Unit 11 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  1. Slide Set - Unit 2 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  2. Slide Set - Unit 5 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  3. Slide Set - Unit 7 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  4. Slide Set - Unit 6 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  5. Slide Set - Unit 4 - People and Animals: United for Health

    NSDL National Science Digital Library

    Dr. Leslie Nader (MSMR)

    1992-07-01

    The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

  6. 21 CFR 864.5850 - Automated slide spinner.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  7. 21 CFR 864.5850 - Automated slide spinner.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    DOEpatents

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

    1981-01-01

    The present invention is directed to a mechanism by which small deviations in slideway straightness and roll of a precision machining apparatus may be compensated for. The mechanism of the present invention comprises a fixture support disposed between the slideway carriage and the tool or workpiece fixture and provided with a hinge-like coupling between the carriage and the fixture support so as to allow for the minute and precise displacement of the fixture support in a direction normal to the direction of the slide path so as to readily compensate for slight deviations in the straightness and roll of the slide path.

  9. Feedback Linearization Control of Inverter Fed Induction Motor - with Sliding Mode Speed and Flux Observers

    Microsoft Academic Search

    Dariusz Sobczuk; Mariusz Malinowski

    2006-01-01

    This paper presents a feedback linearization approach for high performance induction motor control. Some oscillograms illustrating the properties of the PWM inverter-fed induction motor with control via feedback linearization are presented. The sliding mode observer is used to estimate the rotor flux and the angular speed of the motor

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

    ERIC Educational Resources Information Center

    Parkinson, John; Hollamby, Peter

    2003-01-01

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

  11. Winter 2008 Presentation Guidelines

    E-print Network

    Shatkay, Hagit

    they perform? Are there any trade-offs or down-sides in using the proposed method? · Are the methods + questions should have about 20-23 slides. Heavily technical slides take longer · Plan for questions time to rush through the whole thing or insist on going through all your slides. Rushing blurs the material

  12. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data. PMID:25160375

  13. An analysis of FDA-approved drugs for pain and anesthesia.

    PubMed

    Kinch, Michael S

    2015-01-01

    The need to alleviate pain is among the first recorded uses for medicines, dating back to the onset of the Neolithic period. The need persists and many of today's best-known drugs (e.g. aspirin, acetaminophen, morphine) are included within this category. An analysis of FDA-approved new molecular entities (NMEs) for pain and anesthesia reveals a fluctuating rate of new introductions, which has plummeted in recent years. The largest emphasis has been placed on acute pain, largely targeting G-protein-coupled receptors and a relatively narrow subset of molecular pathways. NMEs targeting anesthesia tend to focus on channels and four molecular pathways capture a large majority of NMEs for this indication. PMID:25218931

  14. FDA's nozzle numerical simulation challenge: non-Newtonian fluid effects and blood damage.

    PubMed

    Trias, Miquel; Arbona, Antonio; Massó, Joan; Miñano, Borja; Bona, Carles

    2014-01-01

    Data from FDA's nozzle challenge-a study to assess the suitability of simulating fluid flow in an idealized medical device-is used to validate the simulations obtained from a numerical, finite-differences code. Various physiological indicators are computed and compared with experimental data from three different laboratories, getting a very good agreement. Special care is taken with the derivation of blood damage (hemolysis). The paper is focused on the laminar regime, in order to investigate non-Newtonian effects (non-constant fluid viscosity). The code can deal with these effects with just a small extra computational cost, improving Newtonian estimations up to a ten percent. The relevance of non-Newtonian effects for hemolysis parameters is discussed. PMID:24667931

  15. Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.

    PubMed

    Parekh, A; Buckman-Garner, S; McCune, S; ONeill, R; Geanacopoulos, M; Amur, S; Clingman, C; Barratt, R; Rocca, M; Hills, I; Woodcock, J

    2015-03-01

    The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development. PMID:25670629

  16. The lag from FDA approval to published cost-utility evidence.

    PubMed

    Chambers, James D; Thorat, Teja; Pyo, Junhee; Neumann, Peter J

    2015-06-01

    The lag between FDA approval and publication of cost-utility evidence can hamper payers from accounting for value for money in coverage and reimbursement decisions. We examine this gap, and whether it has changed over time. For drugs approved from 2000 to 2010 (n = 274), we searched the Tufts Medical Center Cost-Effectiveness Analysis Registry to identify relevant cost-utility analyses (CUAs). We identified 127 (46%) drugs associated with a CUA, 62 of which had a CUA published in the 3 years following its approval. Compared with drugs approved from 2000 to 2003, a greater proportion of those approved from 2004 to 2006, and from 2007 to 2010, was associated with a CUA published in the 3 years following approval (13 vs 25% [p = 0.06] and 13 vs 32% [p < 0.01], respectively). Study findings indicate that payers now have slightly more rapid access to published CUAs. PMID:25579324

  17. Quality standards and certification requirements for mammography facilities--FDA. Interim rule; opportunity for public comment.

    PubMed

    1994-09-30

    The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA). The MQSA requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This regulation, which amends two previously published interim rules, modifies and adds to the definitions previously set forth. In addition, the interim rule provides a mechanism to request permission to meet alternative requirements, other than those previously set forth, if the proposed alternative requirement is at least as effective as the existing quality standards in achieving quality mammography services for women. PMID:10137648

  18. An overview of FDA-approved new molecular entities: 1827-2013.

    PubMed

    Kinch, Michael S; Haynesworth, Austin; Kinch, Sarah L; Hoyer, Denton

    2014-08-01

    The pharmaceutical industry is undergoing fundamental change and its future is unclear. We performed a meta-analysis by cataloging FDA-approved legacy drugs and new molecular entities (NMEs). Objective information regarding scientific, medical and commercial activities was captured and provides insight into processes governing drug development. In this report, we review the rates of NME introduction through to the end of 2013. Recent trends show the emergence of a handful of companies that controls two-thirds of NMEs. We also report growth in the number of NMEs controlled by marketing organizations that have little or no internal drug discovery or development activities. This trend has increased dramatically since 2000 and could raise important questions about the future landscape and viability of drug discovery and development. PMID:24680947

  19. A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process

    PubMed Central

    Canfield, Kip; Ritondo, Michele; Sponaugle, Richard

    1998-01-01

    This primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure. PMID:9760391

  20. The Trænadjupet Slide, offshore Norway — morphology, evacuation and triggering mechanisms

    Microsoft Academic Search

    J. S. Laberg; T. O. Vorren

    2000-01-01

    The Trænadjupet Slide, located on the continental slope off Norway, was studied using TOBI (Towed Ocean Bottom Instrument) high-resolution side-scan sonar data together with 7.5kHz seismic records. The slide extends from the shelf break to more than 3000m water depth in the Lofoten Basin, implying a slide-affected area of about 14,100km2. The slide probably occurred during the mid-Holocene, prior to

  1. Unlubricated sliding wear of pearlitic and bainitic steels

    Microsoft Academic Search

    C. C. Viáfara; M. I. Castro; J. M. Vélez; A. Toro

    2005-01-01

    Sliding wear has a great influence on the performance of rail–wheel systems, especially because the wheel flange slides over the rail in a curve track. Since rail–wheel sliding introduces adhesive effects, high slip ratios strongly affect the rolling contact fatigue wear acting on the surfaces. Sliding wear tests were carried out in a pin-on-disk device to study the behavior of

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

    PubMed

    Chidentree, Treesatayapun; Sermsak, Uatrongjit

    2006-11-01

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

  3. Permanent Magnet DC Motor Sliding Mode Control System

    NASA Astrophysics Data System (ADS)

    Vaez-Zadeh, S.; Zamanian, M.

    2000-09-01

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

  4. Inhomogeneity problem with a sliding interface under remote shearing stress

    NASA Astrophysics Data System (ADS)

    Zhao, YingTao; Gao, Yang; Wang, MinZhong

    2012-11-01

    The problem of an ellipsoidal inhomogeneity embedded in an infinitely extended elastic medium with sliding interfaces is investigated. An exact solution is presented for such an inhomogeneous system that is subject to remote uniform shearing stress. Both the elastic inclusion and matrix are considered isotropic with a separate elastic modulus. Based on Lur'e's approach to solving ellipsoidal cavity problems through Lamé functions, several harmonic functions are introduced for Papkovich-Neuber displacement potentials. The displacement fields inside and outside the ellipsoidal inclusion are obtained explicitly, and the stress field in the whole domain is consequently determined.

  5. Design of adaptive fuzzy sliding mode for nonlinear system control

    Microsoft Academic Search

    Sinn-Cheng Lin; Yung-Yaw Chen

    1994-01-01

    An adaptive fuzzy sliding mode controller (AFSMC) is proposed. The parameters of the membership functions in the fuzzy rule base are changed according to some adaptive algorithm for the purpose of controlling the system state to hit a user-defined sliding surface and then slide along it. The initial IF-THEN rules in the AFSMC can be randomly selected or roughly given

  6. Practical Force-Motion Models for Sliding Manipulation

    Microsoft Academic Search

    Robert D. Howe; Mark R. Cutkosky

    1996-01-01

    The goal of this article is to develop practical descriptions of the relationship between forces and motions in sliding manipu lation. We begin by reviewing the limit surface, a concept from the mechanics of sliding bodies that uses kinematic analysis to find the force and moment required to produce any given sliding motion. Next we provide experimental results showing that

  7. The Classification of Art Slides: A Survey and Recommendations.

    ERIC Educational Resources Information Center

    Watt, Richard S.

    The nature and variety of classification systems for museum and university art department slide collections are surveyed through a review of the literature on slide classification in the United States, Great Britain, and Australia, and through case studies of major slide collections at Duke University, the University of North Carolina at Chapel…

  8. LSPE SAFE/ ARM SLIDE DATE 28 March 197

    E-print Network

    Rathbun, Julie A.

    : ..'; I ~ ··,~ ' . LSPE SAFE/ ARM SLIDE NO. ATM-1088 REV. NO. PAGE OF- DATE 28 March 197 FAILURE/ ARM SLIDE FAILURE EVALUATION REPORT TABLE OF CONTENTS PURPOSE BACKGROUND DESCRIPTION OF FAILURE ' LSPE SAFE/ ARM SLIDE FAILURE EVALUATION REPORT PAGI Aerospace /~~stems Divi8lon Figure 1 Figure 2a

  9. Sliding distance, contact pressure and wear in sheet metal stamping

    Microsoft Academic Search

    Michael P. Pereira; Wenyi Yan; Bernard F. Rolfe

    2010-01-01

    This paper directly examines the contact sliding distance experienced during a typical sheet metal stamping process—an area that has largely been neglected in the literature. A method to numerically quantify the sliding distance is proposed. The sliding distance predicted from this method, and the contact pressure obtained from numerical simulation, allow the recently identified time-dependent contact conditions on the die

  10. Sliding wear of conventional and nanostructured cemented carbides

    Microsoft Academic Search

    K. Jia; T. E. Fischer

    1997-01-01

    The sliding wear mechanisms of cemented carbide and the effects of the microstructure scale on the wear resistance were investigated by performing a series of unlubricated sliding wear tests in air with pins of WC?Co composites sliding against silicon nitride disks. In the first approximation, the wear rate is proportional to the hardness with a wear coefficient k = 6.9

  11. 45 CFR 98.42 - Sliding fee scales.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...2010-10-01 false Sliding fee scales. 98.42 Section 98.42 Public...Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall establish...periodically revise, by rule, a sliding fee scale(s) that provides for cost...

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

    NASA Astrophysics Data System (ADS)

    Sharma, Pardeep; Sharma, Satpal; Khanduja, Dinesh

    2015-07-01

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

  13. Sliding thermoelastodynamic instability BY L. AFFERRANTE

    E-print Network

    Daly, Samantha

    -like materials (Barquins et al. 1996), the generation of noise and vibration in automotive brakes (Kincaid et al. These can generally be characterized as either elastodynamic (e.g. `brake squeal') or thermoelastic in more complex practical sliding systems such as brakes and clutches, implying the need

  14. Slide #1CENTER FOR INTEGRATED ACCESS NETWORKS

    E-print Network

    Kieu, Khanh

    James Clerk Maxwell (1831­1879) #12;Slide #9CENTER FOR INTEGRATED ACCESS NETWORKS Maxwell's equations All-time top ten: 1. Albert Einstein 2. Isaac Newton 3. James Clerk Maxwell 4. Niels Bohr 5. Werner propagation Outline: · Maxwell's equations · Wave equation · Boundary conditions · Wave propagation through

  15. Neuro sliding mode control of robotic manipulators

    Microsoft Academic Search

    Meliksah Ertugrul; Okyay Kaynak

    2000-01-01

    In this paper, a synergistic combination of neural networks with sliding mode control (SMC) methodology is proposed. As a result, the chattering is eliminated and error performance of SMC is improved. In the approach, two parallel Neural Networks (NNs) are utilized to realize a neuro-SMC. The equivalent control and the corrective control terms of SMC are the outputs of the

  16. Slide #1CENTER FOR INTEGRATED ACCESS NETWORKS

    E-print Network

    Kieu, Khanh

    design · Raman amplifiers Module 11: Fiber Optic Networks and the Internet (M. Fallahi) · Network switching Raman Amplifiers · Better noise performance compared to EDFA Optical parametric amplifier · High: The working principle of Raman and Parametric amplifiers is different #12;Slide #10CENTER FOR INTEGRATED

  17. Title Slide "Balancing static and dynamic testing

    E-print Network

    Hatton, Les

    is the number of faults divided by the number of lines of code #12;v. 1.2, 09/Mar/2000 , (slide 1 - 5 Faults per 1000 lines DKLOC Time of testing Fault density depends on how much the system has been used the definitions ­ A fault is a statically detectable property of a piece of code or a design ­ A failure

  18. The characterization of the Frank Slide deposit

    Microsoft Academic Search

    Marie Charrière; Andrea Pedrazzini; Maria Güell Pons; Michele Volpi; Michel Jaboyedoff; Corey Froese; Mikhaïl. Kanevski

    2010-01-01

    On the night of the 29th April 1903, approximately 30 millions of cubic meters of limestone slided down the east face of Turtle Mountain (Alberta, Canada). Having killed about 80 people in the village of Frank, the rock avalanche was named after it. The characteristics of this large event are an especially long runout distance of 3 km, a primary

  19. Ceramic wear in indentation and sliding contact

    NASA Technical Reports Server (NTRS)

    Miyoshi, K.; Buckley, D. H.

    1985-01-01

    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.

  20. 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.

  1. TitleSlide 2004-" SomenotesonRisk"

    E-print Network

    Hatton, Les

    Contract ­ LawofTort (negligence) ­ Product Liability(Consumer Protection Act) #12;© Copyright Les Hatton, 2003 Hatton, UKC, December 2003 , (slide 1 - 6) HowmanywayscanIsuethee? y Product liability(ConsumerProtectionAct regimes (Sale of Goods Act) or (Goods and Services) ­ Contractsshouldallowforfailureandmitigateaccordingly

  2. 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…

  3. Analysis of comb transducers with sliding teeth

    Microsoft Academic Search

    Eugene J. Danicki

    2011-01-01

    Ultrasonic comb transducer generates surface acoustic waves on an elastic substrate by periodic traction exerted by its vibrating periodic teeth on the substrate surface. In this paper, the comb teeth are actually sliding elastic spacers between an acoustic buffer and the substrate. The incident wave in acoustic buffer scatters on periodic spacers producing interface waves in the system which transform

  4. Bruce Jacob SLIDE 1 Sensing, Actuation, Control

    E-print Network

    Jacob, Bruce

    · On nearly every steam engine made · Sensor: centrifugal pendulum · Actuator: valve · Power: torque on shaft. Bruce Jacob Electrical & Computer Engineering (with enormous thanks to Prof. Bill Levine) OUTLINEP CoM CoM CoP CoP #12;SENSORS & CONTROL ENES 100 Bruce Jacob SLIDE 10 Steam Valve · Plug/spring acts

  5. Kinesin: walking, crawling or sliding along?

    E-print Network

    Yildiz, Ahmet

    are the fastest kinesins (w2 mm secK1 ) that transport synaptic vesicles towards axons in neuKinesin: walking, crawling or sliding along? Ahmet Yildiz and Paul R. Selvin Department of Physics, University of Illinois, Urbana-Champaign, IL 61801, USA Kinesins are microtubule-based motor proteins

  6. Maintaining Stream Statistics over Sliding Windows

    Microsoft Academic Search

    Mayur Datar; Aristides Gionis; Piotr Indyk; Rajeev Motwani

    2002-01-01

    We consider the problem of maintaining aggregates and statistics over data streams, with respect to the last N data elements seen so far. We refer to this model as the sliding window model. We consider the following basic problem: Given a stream of bits, maintain a count of the number of 1's in the last N elements seen from the

  7. Title Slide "Software quality and the

    E-print Network

    Hatton, Les

    . · Braking systems · Engine management systems · Accelerator and other pedal control · Steering #12;v. 1Title Slide 2000- "Software quality and the world automobile industry" by Les Hatton Oakwood.Hatton, 2000- Trends Recent trends in the automobile industry include:- ­ Very rapidly growing software

  8. Technical Presentation ESTEC, 26 September 2008

    E-print Network

    ExoMars Technical Presentation to PB-HME ESTEC, 26 September 2008 Issue 1, Rev 1 D. McCoy and the ExoMars Team #12;PB-HME TECHNICAL PRESENTATION,ESTEC, 26/9/08 slide 2 CONTENTS · SYSTEM OVERVIEW Carrier · ELEMENT DESCRIPTIONS ­ Descent Module ­ Rover Module ­ Lander #12;PB-HME TECHNICAL PRESENTATION

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

    NASA Astrophysics Data System (ADS)

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

    1980-10-01

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

  10. NATURE MEDICINE VOLUME 10 | NUMBER 12 | DECEMBER 2004 1267 The US Food and DrugAdministration (FDA)

    E-print Network

    Cai, Long

    Administration (FDA) may not license for use in the US anAIDS vaccine now in large-scale trials in Thailand because`proof-of-concept'study to provide correlates of immune protection and a safety profile for vaccination.But with 16,000 volun- teers

  11. Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product

    Microsoft Academic Search

    Saeed A Qureshi; Iain J McGilveray

    1999-01-01

    To evaluate variability in drug dissolution testing 28 laboratories analyzed USP calibrators, US FDA prednisone tablets and a marketed glibenclamide tablet product. The experiments were conducted using paddle and basket methods at 50 (calibrators) and 75 (glibenclamide) rpm. The media employed were deaerated by equilibrating at 37°C for 24 h and by the USP recommended method. The 95% CI values

  12. 2 | P a g e The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety

    E-print Network

    Florida, University of

    Agricultural and food products processing 36 65 71 85 Food science technology/processing 26 6 3 8 Total 1992 Change Food Service Managers 320,600 310,000 3% Food Processing Occupations 311,300 348,700 12% Chefs2 | P a g e Background The FDA Food Safety Modernization Act (FSMA), the most sweeping reform

  13. ‘Off-label’ drug use: an FDA regulatory term, not a negative implication of its medical use

    Microsoft Academic Search

    W A Meadows; B D Hollowell

    2008-01-01

    As physicians continue to prescribe more and more drugs, plaintiff's attorneys in the wake of tort reform are attempting to carve out or create informed consent cases based on the Food and Drug Administration's (FDA) labeling requirements and the doctors' communications with their patients as it relates to those requirements. The theory of tort litigation revolves around whether the doctor

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ...Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability...availability of a draft guidance entitled ``In Vitro Companion Diagnostic Devices.'' This...product that depends on the use of an in vitro companion diagnostic device for its...

  15. Independent components analysis to increase efficiency of discriminant analysis methods (FDA and LDA): Application to NMR fingerprinting of wine.

    PubMed

    Monakhova, Yulia B; Godelmann, Rolf; Kuballa, Thomas; Mushtakova, Svetlana P; Rutledge, Douglas N

    2015-08-15

    Discriminant analysis (DA) methods, such as linear discriminant analysis (LDA) or factorial discriminant analysis (FDA), are well-known chemometric approaches for solving classification problems in chemistry. In most applications, principle components analysis (PCA) is used as the first step to generate orthogonal eigenvectors and the corresponding sample scores are utilized to generate discriminant features for the discrimination. Independent components analysis (ICA) based on the minimization of mutual information can be used as an alternative to PCA as a preprocessing tool for LDA and FDA classification. To illustrate the performance of this ICA/DA methodology, four representative nuclear magnetic resonance (NMR) data sets of wine samples were used. The classification was performed regarding grape variety, year of vintage and geographical origin. The average increase for ICA/DA in comparison with PCA/DA in the percentage of correct classification varied between 6±1% and 8±2%. The maximum increase in classification efficiency of 11±2% was observed for discrimination of the year of vintage (ICA/FDA) and geographical origin (ICA/LDA). The procedure to determine the number of extracted features (PCs, ICs) for the optimum DA models was discussed. The use of independent components (ICs) instead of principle components (PCs) resulted in improved classification performance of DA methods. The ICA/LDA method is preferable to ICA/FDA for recognition tasks based on NMR spectroscopic measurements. PMID:25966381

  16. Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration--FDA. Tentative final rule.

    PubMed

    1991-11-26

    The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance. PMID:10115705

  17. FDA Revised Campylobacter Detection Method from Food Samples Greg Gharst1, Sravani Chancharem2, Don H. Bark3 and Carlos Abeyta3.

    E-print Network

    Heller, Barbara

    FDA Revised Campylobacter Detection Method from Food Samples Greg Gharst1, Sravani Chancharem2, Don U.S. Food and Drug Administration (FDA) protocol for Campylobacter detection and identification of Campylobacter. One hundred and sixty-six strains were analyzed using Campylobacter jejuni (34 strains

  18. FDA regulations require acidified foods and low acid canned foods to be produced under the watchful eye of trained supervisors. USDA/FSIS regulations also require

    E-print Network

    Hayes, Jane E.

    Better Process Control School FDA regulations require acidified foods and low acid canned foods Control School is designed to train you in processing Acidified Foods under FDA regulations to ensure safe of Thermal Processing Food Plant Sanitation Audience: This course is specifically designed to meet

  19. Presentations: Giving Effective Presentations

    E-print Network

    speaking in public in lowrisk, unevaluated situations, such as the Student Learning Commons' English the whole presentation. o Focus on learning the flow of ideas rather than exact wording. o Memorize small and prepare their answers. Familiarize yourself with the room setup and the available technology. SPEAKING

  20. Presentations Giving Effective Presentations

    E-print Network

    speaking in public in low-risk situations, such as the English Conversation Group at the Student Learning Focus on learning the flow of ideas rather than exact wording. o Memorize small parts their answers. Familiarize yourself with the room setup and the available technology BEFORE your presentation