Science.gov

Sample records for fda briefing package

  1. Awareness of FDA-mandated cigarette packaging changes among smokers of 'light' cigarettes.

    PubMed

    Falcone, M; Bansal-Travers, M; Sanborn, P M; Tang, K Z; Strasser, A A

    2015-02-01

    Previous research has clearly demonstrated that smokers associate cigarette descriptors such as 'light', 'ultra-light' and 'low tar' with reduced health risks, despite evidence showing that cigarettes with these descriptor terms do not present lower health risk. In June 2010, regulations implemented by the US Food and Drug Administration went into effect to ban the use of 'light', 'mild' and 'low' on cigarette packaging. We surveyed smokers participating in human laboratory studies at our Center in Philadelphia, PA, USA shortly after the ban went into effect to determine the extent of awareness of recent cigarette packaging changes among smokers of light cigarettes. In our sample of 266 smokers, 76 reported smoking light cigarettes, but fewer than half of these smokers reported noticing changes to their cigarette packaging. Simple removal of a few misleading terms may be too subtle of a change to register with consumers of so-called 'low tar' cigarettes; more comprehensive regulation of cigarette packaging design may be necessary to gain smokers' attention and minimize misperceptions associated with tobacco pack design characteristics and color.

  2. Preserving Knowledge: The Case for Alkaline Paper. ARL Briefing Package Number 3.

    ERIC Educational Resources Information Center

    Association of Research Libraries, Washington, DC.

    This briefing package consists of a compilation of over 15 papers, fact sheets, and other materials focusing on the use of acid-free papers in books and other publications. The document contains the following: Executive Summary and List of Contents; Some Frequently Asked Questions; "Paper Preservation in Library Collections: Basic Information.…

  3. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  4. Food packaging materials and radiation processing of food: A brief review

    NASA Astrophysics Data System (ADS)

    Chuaqui-Offermanns, N.

    Food is usually packaged to prevent microbial contamination and spoilage. Ionizing radiation can be applied to food-packaging materials in two ways: (i) sterilization of packaging materials for aseptic packaging, and (ii) radiation processing of prepackaged food. In aseptic packaging, a sterile package is filled with a sterile product in a microbiologically controlled environment. In irradiation of prepackaged food, the food and the packaging material are irradiated simultaneously. For both applications, the radiation stability of the packaging material is a key consideration if the technology is to be used successfully. To demonstrate the radiation stability of the packaging material, it must be shown that irradiation does not significantly alter the physical and chemical properties of the material. The irradiated material must protect the food from environmental contamination while maintaining its organoleptic and toxicological properties. Single-layer plastics cannot meet the requirements of either application. Multilayered structures produced by coextrusion would likely satisfy the demands of radiation processing prepackaged food. In aseptic packaging, the package is irradiated prior to filling, making demands on toxicological safety less stringent. Therefore, multilayered structures produced by coextrusion, lamination or co-injection moulding could satisfy the requirements.

  5. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  6. Technical support package: Large, easily deployable structures. NASA Tech Briefs, Fall 1982, volume 7, no. 1

    NASA Technical Reports Server (NTRS)

    1982-01-01

    Design and test data for packaging, deploying, and assembling structures for near term space platform systems, were provided by testing light type hardware in the Neutral Buoyancy Simulator. An optimum or near optimum structural configuration for varying degrees of deployment utilizing different levels of EVA and RMS was achieved. The design of joints and connectors and their lock/release mechanisms were refined to improve performance and operational convenience. The incorporation of utilities into structural modules to determine their effects on packaging and deployment was evaluated. By simulation tests, data was obtained for stowage, deployment, and assembly of the final structural system design to determine construction timelines, and evaluate system functioning and techniques.

  7. A Brief Report on the Effects of a Self-Management Treatment Package on Stereotypic Behavior

    ERIC Educational Resources Information Center

    Moore, Timothy R.

    2009-01-01

    We evaluated the effects of a self-management treatment package (SMTP) on the stereotypic behavior of an adolescent with Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS). Latency to stereotypy was systematically increased in the training setting (academic) and the effectiveness of the SMTP was evaluated within a multiple-probe…

  8. FDA Certified Mammography Facilities

    MedlinePlus

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

  9. FDA Certified Mammography Facilities

    MedlinePlus

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

  10. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  11. Is It Really FDA Approved?

    MedlinePlus

    ... FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers ... dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device ...

  12. Design Brief--Packaging: More than Just a Box! Communications: Getting the Message across with Advertising. Technology Learning Activities.

    ERIC Educational Resources Information Center

    Technology Teacher, 1991

    1991-01-01

    Each technology learning activity in this article includes content description, objectives, required materials, challenge, and evaluation questions. Subjects are designing product packages and communication through advertising. (SK)

  13. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

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

  14. FDA's evolving approach to nanotechnology.

    PubMed

    Monica, John C

    2012-01-01

    Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several years, questions concerning the effectiveness of existing regulations have emerged. After a period of study and analysis, the FDA has issued three (3) draft guidance documents over the last eighteen (18) months pertaining to the use of nanoscale materials and nanotechnology in certain FDA-regulated products. As these are likely to become the "de facto" standards they merit further analysis. This article examines these draft guidance documents and provides modest commentary for those practicing in the area.

  15. A Guide to the FDA.

    ERIC Educational Resources Information Center

    Miller, Annetta K.

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

  16. FDA-Approved HIV Medicines

    MedlinePlus

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with ... 2007 Pharmacokinetic Enhancers Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine ...

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

    PubMed

    O'Reilly, James T

    2009-01-01

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

  18. US FDA's revised consumption factor for polystyrene used in food-contact applications.

    PubMed

    Cassidy, K; Elyashiv-Barad, S

    2007-09-01

    US FDA's continual effort to evaluate the safety of food-contact materials includes periodically re-examining our established packaging factors, such as consumption and food-type distribution factors. The use of polystyrene in food-contact and disposable food-packaging applications has expanded and is expected to continue to increase in the future. Therefore, it is important to revise the polystyrene consumption factor to account for increases in consumer exposure to substances migrating from styrenic food packaging. The currently used consumption factor for polystyrene is 0.1, which is based on market data collected around 1980. US FDA has revised the polystyrene consumption factor utilizing three different sources of market data. Using consumption and population data, US FDA calculated a new consumption factor of 0.14 for polystyrene. This consumption factor has been further subdivided to allow for the refinement of exposure estimates for uses limited to specific subcategories of polystyrene packaging.

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

    PubMed

    Hopkins, R J

    1997-12-01

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

  20. Internet Database Review: The FDA BBS.

    ERIC Educational Resources Information Center

    Tomaiuolo, Nicholas G.

    1993-01-01

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

  1. 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.

  2. Access to F.D.A. Information.

    ERIC Educational Resources Information Center

    Sinovic, Dianna

    Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

  3. Battery packaging - Technology review

    SciTech Connect

    Maiser, Eric

    2014-06-16

    This paper gives a brief overview of battery packaging concepts, their specific advantages and drawbacks, as well as the importance of packaging for performance and cost. Production processes, scaling and automation are discussed in detail to reveal opportunities for cost reduction. Module standardization as an additional path to drive down cost is introduced. A comparison to electronics and photovoltaics production shows 'lessons learned' in those related industries and how they can accelerate learning curves in battery production.

  4. 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.

  5. Planning for effective interaction with FDA.

    PubMed

    Spurgin, Elizabeth A

    2004-12-01

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

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

    PubMed Central

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

    2012-01-01

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

  7. An Examination of the Effects of a Video-Based Training Package on Professional Staff's Implementation of a Brief Functional Analysis and Data Analysis

    ERIC Educational Resources Information Center

    Fleming, Courtney V.

    2011-01-01

    Minimal research has investigated training packages used to teach professional staff how to implement functional analysis procedures and to interpret data gathered during functional analysis. The current investigation used video-based training with role-play and feedback to teach six professionals in a clinical setting to implement procedures of a…

  8. New Eczema Drug Gets FDA's Blessing

    MedlinePlus

    ... page: https://medlineplus.gov/news/fullstory_164327.html New Eczema Drug Gets FDA's Blessing Injections may ease ... News) -- Adults plagued by eczema may have a new treatment option, with a new drug approved Tuesday ...

  9. FDA Warns Against Bogus Autism 'Cures'

    MedlinePlus

    ... news/fullstory_164602.html FDA Warns Against Bogus Autism 'Cures' Unproven therapies won't help and could ... Don't fall for products claiming to cure autism, the U.S. Food and Drug Administration warns. There's ...

  10. FDA Suggests Limits on Lead in Cosmetics

    MedlinePlus

    ... 162726.html FDA Suggests Limits on Lead in Cosmetics Agency notes most products already below recommended level ... limit on how much lead can be in cosmetics ranging from lipstick and eye shadow to blush ...

  11. FDA Approves First Immunotherapy for Lymphoma

    Cancer.gov

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  12. 76 FR 36627 - Required Warnings for Cigarette Packages and Advertisements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health......

  13. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the...

  14. 42 CFR 405.203 - FDA categorization of investigational devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  15. Of poops and parasites: unethical FDA overregulation.

    PubMed

    Young, Kenneth A

    2014-01-01

    Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.

  16. The FDA and the new biology.

    PubMed

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

    2008-12-01

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

  17. 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

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

    PubMed Central

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

    2015-01-01

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

  19. 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

  20. Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA

    MedlinePlus

    ... medlineplus.gov/news/fullstory_163464.html Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA Agency recommends getting ... by the human papillomavirus (HPV). An FDA-approved vaccine called Gardasil 9 protects against 9 HPV types ...

  1. Agenda: EDRN FDA Education Workshop — EDRN Public Portal

    Cancer.gov

    The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.

  2. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  3. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  4. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  5. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  6. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  8. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. 21 CFR 806.30 - FDA access to records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA access to records. 806.30 Section 806.30 Food... DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to... designated by FDA and under section 704(e) of the act, permit such officer or employee at all...

  10. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  11. Sterile Product Packaging and Delivery Systems.

    PubMed

    Akers, Michael J

    2015-01-01

    Both conventional and more advanced product container and delivery systems are the focus of this brief article. Six different product container systems will be discussed, plus advances in primary packaging for special delivery systems and needle technology.

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  13. Fisher, Neyman, and Bayes at FDA.

    PubMed

    Rubin, Donald B

    2016-01-01

    The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

  14. 76 FR 81363 - Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction AGENCY... (76 FR 11892). The final rule amended FDA's regulations for thermally processed low-acid...

  15. 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... Technologists (IFT) report to FDA and the submission of information relevant to improving product tracing. The... comments on the findings and recommendations contained in the IFT report and the submission of information relevant to improving product tracing. Comments on the findings and recommendations contained in the...

  16. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... appropriate technologies that enhance the tracking and tracing of foods along the supply chain from source to... ingredients (minimum of two ingredients) and (b) a selected fruit and/or vegetable along the supply chain; 7... along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders...

  17. NFR TRIGA package design review report

    SciTech Connect

    Clements, M.D.

    1994-08-26

    The purpose of this document is to compile, present and document the formal design review of the NRF TRIGA packaging. The contents of this document include: the briefing meeting presentations, package description, design calculations, package review drawings, meeting minutes, action item lists, review comment records, final resolutions, and released drawings. This design review required more than two meeting to resolve comments. Therefore, there are three meeting minutes and two action item lists.

  18. Naming, labeling, and packaging of pharmaceuticals.

    PubMed

    Kenagy, J W; Stein, G C

    2001-11-01

    The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

  19. Scoring Package

    National Institute of Standards and Technology Data Gateway

    NIST Scoring Package (PC database for purchase)   The NIST Scoring Package (Special Database 1) is a reference implementation of the draft Standard Method for Evaluating the Performance of Systems Intended to Recognize Hand-printed Characters from Image Data Scanned from Forms.

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

    SciTech Connect

    Baratta, E.J. )

    1992-01-01

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

  1. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    PubMed

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  2. FDA Drug Approval: Review Time Has Decreased in Recent Years.

    DTIC Science & Technology

    1995-10-01

    New drugs marketed in the United States must be approved first by the Food and Drug Administration (FDA). Approval comes after FDA has determined...reform argue that shortening the time it takes to get new drugs approved will contribute both to public health, by making effective therapies

  3. What FDA Learned About Dark Chocolate and Milk Allergies

    MedlinePlus

    ... advisor at FDA. back to top Not Quite ‘Dairy Free’ In addition to these advisory statements, labels ... chocolate bars may make other claims. Some say “dairy-free” or “lactose free,” but FDA found milk ...

  4. 21 CFR 5.1110 - FDA public information offices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  6. Examining the FDA's oversight of direct-to-consumer advertising.

    PubMed

    Gahart, Martin T; Duhamel, Louise M; Dievler, Anne; Price, Roseanne

    2003-01-01

    Our analysis examined the effects of the Food and Drug Administration's (FDA's) 1997 draft guidance regarding advertisements for prescription drugs broadcast directly to consumers. We found that although direct-to-consumer (DTC) advertising spending by pharmaceutical companies has increased, more than 80 percent of their promotional spending is directed to physicians. DTC advertising appears to increase the use of prescription drugs among consumers. The FDA's oversight has not prevented companies from making misleading claims in subsequent advertisements, and a recent policy change has lengthened the FDA's review process, raising the possibility that some misleading campaigns could run their course before review.

  7. FDA perspective: enrolment of elderly transplant recipients in clinical trials.

    PubMed

    Meyer, Joette M; Archdeacon, Patrick; Albrecht, Renata

    2013-04-15

    Since 1989, the U.S. Food and Drug Administration (FDA) has encouraged the study of new drug and therapeutic products in elderly patients. However, despite the aging population in the United States, elderly patients continue to be underrepresented in clinical trials across a variety of therapeutic areas, including transplantation. The currently available tools for the FDA to encourage and require the evaluation and reporting of safety and efficacy information in elderly patients are summarized. Clinicians, sponsors, and investigators are encouraged to work with the FDA to expand the enrolment of elderly patients in clinical trials of transplantation.

  8. FDA to Weigh Dangers of Exploding E-Cigarettes

    MedlinePlus

    ... FDA had identified 66 instances of e-cigarette explosions in 2015 and early 2016. The batteries overheated, ... that e-cigarettes pose no more fire or explosion risk than other devices that rely on lithium- ...

  9. FDA Encourages More Participation, Diversity in Clinical Trials

    MedlinePlus

    ... or older and people from certain racial and ethnic groups. That’s why the FDA is encouraging more ... clinical trials, especially people of different ages, races, ethnic groups, and genders. Read on to learn more ...

  10. FDA Approves New Treatment for Dust Mite Allergies

    MedlinePlus

    ... 163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra is a year-round treatment for ... 2017 (HealthDay News) -- A new treatment for dust mite allergies has won approval from the U.S. Food ...

  11. America's Porky Pets Face Health Woes, Too, FDA Says

    MedlinePlus

    ... Woes, Too, FDA Says More than half of dogs, cats in the Land of Plenty weigh too ... its pets, with a majority of cats and dogs dangerously overweight, a federal government veterinarian warns. "Just ...

  12. FDA Bacteriological Analytical Manual, Chapter 10, 2003: Listeria monocytogenes

    EPA Pesticide Factsheets

    FDA Bacteriological Analytical Manual, Chapter 10 describes procedures for analysis of food samples and may be adapted for assessment of solid, particulate, aerosol, liquid and water samples containing Listeria monocytogenes.

  13. FDA Issues Anesthesia Warning for Pregnant Women, Kids Under 3

    MedlinePlus

    ... gov/news/fullstory_162543.html FDA Issues Anesthesia Warning for Pregnant Women, Kids Under 3 A long ... latest published studies, the agency announced that these warnings need to be added to the labels of ...

  14. FDA Throws Cold Water on Whole Body Cryotherapy

    MedlinePlus

    ... html FDA Throws Cold Water on Whole Body Cryotherapy Exposure to ultra-low temperatures shows no benefits ... evidence that a growing trend called whole body cryotherapy is effective, but it does pose a number ...

  15. 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

  16. Subarray-based FDA radar to counteract deceptive ECM signals

    NASA Astrophysics Data System (ADS)

    Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

    2016-12-01

    In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

  17. Seafood Packaging

    NASA Technical Reports Server (NTRS)

    1996-01-01

    NASA's Technology Transfer Office at Stennis Space Center worked with a New Orleans seafood packaging company to develop a container to improve the shipping longevity of seafood, primarily frozen and fresh fish, while preserving the taste. A NASA engineer developed metalized heat resistant polybags with thermal foam liners using an enhanced version of the metalized mylar commonly known as 'space blanket material,' which was produced during the Apollo era.

  18. Packaged Food

    NASA Technical Reports Server (NTRS)

    1976-01-01

    After studies found that many elderly persons don't eat adequately because they can't afford to, they have limited mobility, or they just don't bother, Innovated Foods, Inc. and JSC developed shelf-stable foods processed and packaged for home preparation with minimum effort. Various food-processing techniques and delivery systems are under study and freeze dried foods originally used for space flight are being marketed. (See 77N76140)

  19. Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?

    PubMed Central

    Connolly, Gregory N; Alpert, Hillel R

    2014-01-01

    Background Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of “Lights” descriptors or similar terms on tobacco products that convey messages of reduced risk. Manufacturers eliminated terms explicitly stated and substituted colour name descriptors corresponding to the banned terms. This paper examines whether the tobacco industry complied with or circumvented the law and potential FDA regulatory actions. Methods Philip Morris retailer manuals, manufacturers' annual reports filed with the Massachusetts Department of Public Health, a national public opinion survey, and market-wide cigarette sales data were examined. Results Manufacturers substituted “Gold” for “Light” and “Silver” for “Ultra-light” in the names of Marlboro sub-brands, and “Blue”, “Gold”, and “Silver” for banned descriptors in sub-brand names. Percent filter ventilation levels, used to generate the smoke yield ranges associated with “Lights” categories, appear to have been reassigned to the new colour brand name descriptors. Following the ban, 92% of smokers reported they could easily identify their usual brands, and 68% correctly named the package colour associated with their usual brand, while sales for “Lights” cigarettes remained unchanged. Conclusions Tobacco manufacturers appear to have evaded a critical element of the FSPTCA, the ban on misleading descriptors that convey reduced health risk messages. The FPSTCA provides regulatory mechanisms, including banning these products as adulterated (Section 902). Manufacturers could then apply for pre-market approval as new products and produce evidence for FDA evaluation and determination whether or not sales of these products are in the public health interest. PMID:23485704

  20. Awareness of FDA-Mandated Cigarette Packaging Changes among Smokers of "Light" Cigarettes

    ERIC Educational Resources Information Center

    Falcone, M.; Bansal-Travers, M.; Sanborn, P. M.; Tang, K. Z.; Strasser, A. A.

    2015-01-01

    Previous research has clearly demonstrated that smokers associate cigarette descriptors such as "light", "ultra-light" and "low tar" with reduced health risks, despite evidence showing that cigarettes with these descriptor terms do not present lower health risk. In June 2010, regulations implemented by the US Food and…

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

    PubMed

    Ferrer, Elisa

    2010-06-01

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

  2. A hard look at FDA's review of GRAS notices.

    PubMed

    Roberts, Ashley; Haighton, Lois A

    2016-08-01

    Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of "reasonable certainty of no harm" is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of "FDA has no questions", "Notice does not provide a basis for a GRAS determination", or, "At Notifier's request, FDA ceased to evaluate the notice." Of 528 notices reviewed, there were 393 "no questions letters", 17 "insufficient basis letters", and 84 "cease to evaluate letters". Of those deemed to be insufficient, most failed to meet the general recognition criteria. Only four raised questions about potential safety, of which three received a no questions letter upon providing more data. Of the 84 withdrawn notices, 22 received a no questions letter upon resubmission. In spite of criticisms, the FDA GRAS notice process is clearly defined, efficient, and cost-effective, and there have been no known public health issues following its implementation.

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

    PubMed

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

    2006-11-01

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

  4. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  6. Issue briefs on low-level radioactive wastes

    SciTech Connect

    Not Available

    1981-01-01

    This report contains 4 Issue Briefs on low-level radioactive wastes. They are entitled: Handling, Packaging, and Transportation, Economics of LLW Management, Public Participation and Siting, and Low Level Waste Management.

  7. Reflective Packaging

    NASA Technical Reports Server (NTRS)

    1994-01-01

    The aluminized polymer film used in spacecraft as a radiation barrier to protect both astronauts and delicate instruments has led to a number of spinoff applications. Among them are aluminized shipping bags, food cart covers and medical bags. Radiant Technologies purchases component materials and assembles a barrier made of layers of aluminized foil. The packaging reflects outside heat away from the product inside the container. The company is developing new aluminized lines, express mailers, large shipping bags, gel packs and insulated panels for the building industry.

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

    PubMed

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

    2012-12-01

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

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

    PubMed

    James, J S

    1997-12-05

    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.

  10. Court Briefs.

    ERIC Educational Resources Information Center

    Nankivell, R.; And Others

    1990-01-01

    Presents court briefs for three separate constitutional issues: the individual right to die as tested in the "Cruzan v. Missouri Department of Health" case; constitutional rights and drunk driving; and student religious clubs' right to meet at public schools in accordance with the Equal Access Act of 1984. Analyzes court opinions and…

  11. 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.

  12. 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

  13. Bayesian statistics in medical devices: innovation sparked by the FDA.

    PubMed

    Campbell, Gregory

    2011-09-01

    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 in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.

  14. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  15. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  16. 21 CFR 60.10 - FDA assistance on eligibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA assistance on eligibility. 60.10 Section 60.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT... use; (2) For human drug products, food additives, color additives, and medical devices,...

  17. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  18. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  19. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  1. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  2. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  3. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and restrictions. 13.980 Section 13.980 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  4. Packaging Your Training Materials

    ERIC Educational Resources Information Center

    Espeland, Pamela

    1977-01-01

    The types of packaging and packaging materials to use for training materials should be determined during the planning of the training programs, according to the packaging market. Five steps to follow in shopping for packaging are presented, along with a list of packaging manufacturers. (MF)

  5. Do the ends justify the means? A test of alternatives to the FDA proposed cigarette warning labels.

    PubMed

    Byrne, Sahara; Katz, Sherri Jean; Mathios, Alan; Niederdeppe, Jeff

    2015-01-01

    Three studies provide empirical, social scientific tests of alternatives to the originally proposed U.S. Food and Drug Administration (FDA) cigarette package warning labels on health risk beliefs, perceived fear, and effectiveness. Our research addresses questions at the root of the legal disputes surrounding FDA regulation of cigarette package warning labels. Specifically, we describe results from three studies that investigate the mediating role of health beliefs and perceived fear in shaping message effectiveness and intentions to quit. The first study featured nonsmoking young adults, while the second and third studies sampled adult daily smokers. Each study was a randomized experiment with five warning-label image conditions: full-color graphic warning labels, black-and-white graphic warning labels, warning text (no graphic image), Surgeon General's warning labels, and no warning. Results consistently indicate that graphic warning labels (in both color and black-and-white) promote increased perceptions of fear, which in turn are associated with greater (perceived and actual) effectiveness. We conclude with a discussion of the results, highlighting implications, public policy considerations, and suggestions for future research.

  6. Science packages

    NASA Astrophysics Data System (ADS)

    1997-01-01

    Primary science teachers in Scotland have a new updating method at their disposal with the launch of a package of CDi (Compact Discs Interactive) materials developed by the BBC and the Scottish Office. These were a response to the claim that many primary teachers felt they had been inadequately trained in science and lacked the confidence to teach it properly. Consequently they felt the need for more in-service training to equip them with the personal understanding required. The pack contains five disks and a printed user's guide divided up as follows: disk 1 Investigations; disk 2 Developing understanding; disks 3,4,5 Primary Science staff development videos. It was produced by the Scottish Interactive Technology Centre (Moray House Institute) and is available from BBC Education at £149.99 including VAT. Free Internet distribution of science education materials has also begun as part of the Global Schoolhouse (GSH) scheme. The US National Science Teachers' Association (NSTA) and Microsoft Corporation are making available field-tested comprehensive curriculum material including 'Micro-units' on more than 80 topics in biology, chemistry, earth and space science and physics. The latter are the work of the Scope, Sequence and Coordination of High School Science project, which can be found at http://www.gsh.org/NSTA_SSandC/. More information on NSTA can be obtained from its Web site at http://www.nsta.org.

  7. Required warnings for cigarette packages and advertisements. Final rule.

    PubMed

    2011-06-22

    The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.

  8. FDA/CVM's Compliance Policy Guide on compounding of drugs.

    PubMed

    1996-12-15

    As a veterinary practitioner, do you combine drug agents for anesthesia? Create antidotes? Dilute liquids for administration to small, young, or exotic species? Such efforts are examples of compounding. The FDA/CVM's new Compliance Policy Guide (CPG), which regulates the compounding of drugs by veterinarians and pharmacists for use in animals appears here, as originally published in the Compliance Policy Guide Manual. The CPG provides guidance to FDA's field and headquarters staff and serves as a source of useful information to veterinarians. The CPG for Compounding of Drugs for Use in Animals reflects the efforts of a task force made up of a diverse group of veterinarians, pharmacists, and regulators whose conclusions were published in the Symposium of Compounding in JAVMA, July 15, 1994, pp 189-303.

  9. 食品药物管理局( FDA

    Center for Drug Evaluation (CDER)

    ... 士应立即与医疗保健专业人员联络咨询。 接触铅会对中央神经系统、肾、和免疫 系统造成严重的 ... 下载并完成表格,然后经传真至 1-800-FDA-0178 提交。 ...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  11. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  12. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  13. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Commercially... Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

  15. 21 CFR 1.279 - When must prior notice be submitted to FDA?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior... submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than...

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

    PubMed

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

    2016-03-01

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

  17. No sisyphean task: how the FDA can regulate electronic cigarettes.

    PubMed

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  18. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... implement the principles of transparent, collaborative, and participatory government. The Open Government... intended to provide the public with basic information about FDA and how the agency does its work. This... conversations with FDA officials about the work of their Offices. Each month, senior officials from FDA...

  19. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

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

  1. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1... General Provisions § 1.378 What criteria does FDA use to order a detention? An officer or qualified employee of FDA may order the detention of any article of food that is found during an...

  4. 21 CFR 111.610 - What records must be made available to FDA?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010.

    PubMed

    Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E

    2016-04-01

    In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe < 30% (89.6% vs 65.8%, P = .0015). PK studies to assess the impact of dialysis were conducted for 31.7% of NCEs that had a renal study: a greater proportion of high fe NCEs were studied (44.2% vs 26.0%, P = .0335). No significant change in frequency or rigor of PK studies was detected over time. The majority of NCEs (76.3%) with a renal study provided specific dosing recommendations in the API. The adoption of the 1998 FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs.

  6. The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials.

    PubMed

    Marchetti, S; Schellens, J H M

    2007-09-03

    An increase in the number of identified therapeutic cancer targets achieved through recent biomedical research has resulted in the generation of a large number of molecules that need to be tested further. Current development of (anticancer) drugs is a rather inefficient process that for an average new molecule takes around 10-15 years. It is also a challenging process as it is associated with high costs and a low rate of approval. It is known that less than 10% of new molecular entities entering clinical Phase I testing progress beyond the investigational programme and reach the market; this probability is even lower for anticancer agents. In 2003, the US Food and Drug Administration (US FDA) declared the urgent need for new toolkits to improve the critical development path that leads from scientific discovery to the patient. In this scenario, Phase 0 (zero) trials should allow an early evaluation in humans of pharmacokinetic and pharmacodynamic profiles of test compounds through administration of sub-pharmacological doses and for a short time period to a low number of humans. Typically, Phase 0 studies have no therapeutic or diagnostic intent. Owing to the low doses administered and the low risk of toxicity, shorter preclinical packages to support these studies are required. Phase 0 trials have been proposed to help in making an early selection of promising candidates for further evaluation in Phase I-III trials, providing a potentially useful instrument for drug discovery, particularly in the field of oncology. Phase 0 studies are expected to reduce costs of drug development, and to limit the preclinical in vitro and in vivo testing and the time period of drug development. However, there are also concerns about the utility and feasibility of Phase 0 studies. In January 2006, guidelines on exploratory investigational new drug studies in humans have been published by the US FDA, and currently a Phase 0 programme is ongoing at the National Cancer Institute to

  7. 76 FR 11891 - Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ...The Food and Drug Administration (FDA) is amending its regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature- indicating devices, in addition to mercury-in-glass thermometers, during processing. This final rule also establishes recordkeeping requirements relating to temperature-indicating devices and reference......

  8. Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration. Notice.

    PubMed

    1982-09-07

    The Food and Drug Administration (FDA) is revoking the final guideline patient package inserts for 5 classes of drugs and is withdrawing the draft guideline patient package inserts for 5 other classes of drugs. Elsewhere in this issue of the Federal Register, the agency is revoking the regulations that established general requirements for the preparation and distribution of patient package inserts for prescription drug products. Those regulations had established a pilot program that would have been applied to 10 classes of drugs for 3 years. This notice revokes the draft and final guidelines which described how manufactures might comply with the regulations with respect to affected classes of drug.

  9. The critical path from pump to pancreas: the impact of FDA regulation on the development of a closed-loop diabetes management system.

    PubMed

    Sanchez, Rachel M

    2013-01-01

    Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await FDA approval. The artificial pancreas is a prime example of such medical technologies, as one of these device systems has been available in over 40 countries outside of the United States for more than 3 years. The term "artificial pancreas" refers to any one of a group of closed-loop device systems designed to protect type 1 diabetics against dangerous diabetes episodes, while also reducing the risk of diabetes-related complications by enabling tighter glycemic control. The following paper will provide an overview of diabetes, a brief history of diabetes management, the technological challenges of creating a fully functional closed-loop diabetes management system, and the role of FDA in the development of the artificial pancreas.

  10. 2015 in review: FDA approval of new drugs.

    PubMed

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise.

  11. Packaging for Food Service

    NASA Technical Reports Server (NTRS)

    Stilwell, E. J.

    1985-01-01

    Most of the key areas of concern in packaging the three principle food forms for the space station were covered. It can be generally concluded that there are no significant voids in packaging materials availability or in current packaging technology. However, it must also be concluded that the process by which packaging decisions are made for the space station feeding program will be very synergistic. Packaging selection will depend heavily on the preparation mechanics, the preferred presentation and the achievable disposal systems. It will be important that packaging be considered as an integral part of each decision as these systems are developed.

  12. Packaging of MEMS microphones

    NASA Astrophysics Data System (ADS)

    Feiertag, Gregor; Winter, Matthias; Leidl, Anton

    2009-05-01

    To miniaturize MEMS microphones we have developed a microphone package using flip chip technology instead of chip and wire bonding. In this new packaging technology MEMS and ASIC are flip chip bonded on a ceramic substrate. The package is sealed by a laminated polymer foil and by a metal layer. The sound port is on the bottom side in the ceramic substrate. In this paper the packaging technology is explained in detail and results of electro-acoustic characterization and reliability testing are presented. We will also explain the way which has led us from the packaging of Surface Acoustic Wave (SAW) components to the packaging of MEMS microphones.

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

    2015-12-01

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

  15. Integration of new technology into clinical practice after FDA approval.

    PubMed

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  16. Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.

    PubMed

    Sawant, Satin G; Fielden, Mark R; Black, Kurt A

    2014-10-01

    Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.

  17. CH Packaging Operations Manual

    SciTech Connect

    Washington TRU Solutions LLC

    2005-06-13

    This procedure provides instructions for assembling the CH Packaging Drum payload assembly, Standard Waste Box (SWB) assembly, Abnormal Operations and ICV and OCV Preshipment Leakage Rate Tests on the packaging seals, using a nondestructive Helium (He) Leak Test.

  18. Comparative Packaging Study

    NASA Technical Reports Server (NTRS)

    Perchonok, Michele; Antonini, David

    2008-01-01

    This viewgraph presentation describes a comparative packaging study for use on long duration space missions. The topics include: 1) Purpose; 2) Deliverables; 3) Food Sample Selection; 4) Experimental Design Matrix; 5) Permeation Rate Comparison; and 6) Packaging Material Information.

  19. Improving the effect of FDA-mandated drug safety alerts with Internet-based continuing medical education.

    PubMed

    Kraus, Carl N; Baldwin, Alan T; McAllister, R G

    2013-02-01

    The US Food and Drug Administration (FDA) requires risk communication as an element of Risk Evaluation and Mitigation Strategies (REMS) to alert and educate healthcare providers about severe toxicities associated with approved drugs. The educational effectiveness of this approach has not been evaluated. To support the communication plan element of the ipilimumab REMS, a Medscape Safe Use Alert (SUA) letter was distributed by Medscape via email and mobile device distribution to clinicians specified in the REMS. This alert contained the FDA-approved Dear Healthcare Provider (DHCP) letter mandated for distribution. A continuing medical education (CME) activity describing ipilimumab toxicities and the appropriate management was simultaneously posted on the website and distributed to Medscape members. Data were collected over a 6-month period regarding the handling of the letter and the responses to pre- and post-test questions for those who participated in the CME activity. Analysis of the answers to the pre- and posttest questions showed that participation in the CME activity resulted in an improvement in correct answer responses of 47%. Our experience shows that there are likely distinct information sources that are utilized by different HCP groups. The ready availability of a brief CME activity was utilized by 24,063 individuals, the majority of whom showed enhanced understanding of ipilimumab toxicity by improvement in post-test scores, educational data that are not available via implementation of standard safety alert communications. These results demonstrate that improvement in understanding of specific drug toxicities is enhanced by a CME intervention.

  20. ADVANCED ELECTRONIC PACKAGING TECHNIQUES

    DTIC Science & Technology

    MICROMINIATURIZATION (ELECTRONICS), *PACKAGED CIRCUITS, CIRCUITS, EXPERIMENTAL DATA, MANUFACTURING, NONDESTRUCTIVE TESTING, RESISTANCE (ELECTRICAL), SEMICONDUCTORS, TESTS, THIN FILMS (STORAGE DEVICES), WELDING.

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

    PubMed

    Keatley, K L

    1999-01-01

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

  2. Trends in Food Packaging.

    ERIC Educational Resources Information Center

    Ott, Dana B.

    1988-01-01

    This article discusses developments in food packaging, processing, and preservation techniques in terms of packaging materials, technologies, consumer benefits, and current and potential food product applications. Covers implications due to consumer life-style changes, cost-effectiveness of packaging materials, and the ecological impact of…

  3. 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.

  4. Edible packaging materials.

    PubMed

    Janjarasskul, Theeranun; Krochta, John M

    2010-01-01

    Research groups and the food and pharmaceutical industries recognize edible packaging as a useful alternative or addition to conventional packaging to reduce waste and to create novel applications for improving product stability, quality, safety, variety, and convenience for consumers. Recent studies have explored the ability of biopolymer-based food packaging materials to carry and control-release active compounds. As diverse edible packaging materials derived from various by-products or waste from food industry are being developed, the dry thermoplastic process is advancing rapidly as a feasible commercial edible packaging manufacturing process. The employment of nanocomposite concepts to edible packaging materials promises to improve barrier and mechanical properties and facilitate effective incorporation of bioactive ingredients and other designed functions. In addition to the need for a more fundamental understanding to enable design to desired specifications, edible packaging has to overcome challenges such as regulatory requirements, consumer acceptance, and scaling-up research concepts to commercial applications.

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

    PubMed

    James, John S

    2005-12-01

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

  6. Repurposing FDA-approved drugs for anti-aging therapies.

    PubMed

    Snell, Terry W; Johnston, Rachel K; Srinivasan, Bharath; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey

    2016-11-01

    There is great interest in drugs that are capable of modulating multiple aging pathways, thereby delaying the onset and progression of aging. Effective strategies for drug development include the repurposing of existing drugs already approved by the FDA for human therapy. FDA approved drugs have known mechanisms of action and have been thoroughly screened for safety. Although there has been extensive scientific activity in repurposing drugs for disease therapy, there has been little testing of these drugs for their effects on aging. The pool of FDA approved drugs therefore represents a large reservoir of drug candidates with substantial potential for anti-aging therapy. In this paper we employ FINDSITE(comb), a powerful ligand homology modeling program, to identify binding partners for proteins produced by temperature sensing genes that have been implicated in aging. This list of drugs with potential to modulate aging rates was then tested experimentally for lifespan and healthspan extension using a small invertebrate model. Three protein targets of the rotifer Brachionus manjavacas corresponding to products of the transient receptor potential gene 7, ribosomal protein S6 polypeptide 2 gene, or forkhead box C gene, were screened against a compound library consisting of DrugBank drugs including 1347 FDA approved, non-nutraceutical molecules. Twenty nine drugs ranked in the top 1 % for binding to each target were subsequently included in our experimental analysis. Continuous exposure of rotifers to 1 µM naproxen significantly extended rotifer mean lifespan by 14 %. We used three endpoints to estimate rotifer health: swimming speed (mobility proxy), reproduction (overall vitality), and mitochondria activity (cellular senescence proxy). The natural decline in swimming speed with aging was more gradual when rotifers were exposed to three drugs, so that on day 6, mean swimming speed of females was 1.19 mm/s for naproxen (P = 0.038), 1.20 for fludarabine (P = 0

  7. 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.

  8. 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.

  9. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for...

  10. FDA Should Reduce Expensive Antibiotic Testing and Charge Fees Which More Closely Reflect Cost of Certification.

    DTIC Science & Technology

    1981-10-28

    between 1970 and 1979 were not certified because of potency problems. GAO was told by two FDA officials that, except for nonsterile products , if...been low. Batch certification is an expensive product assurance strategy and other less costly control mecha- A nisms are available. Further, GAO...issuing of certificates for batches that pass the tests. Manufacturers may not market products subject to these tests until FDA certifies them. FDA charges

  11. FDA toxicity databases and real-time data entry

    SciTech Connect

    Arvidson, Kirk B.

    2008-11-15

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Wenstrom, Katharine D

    2014-11-01

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

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

    PubMed

    1997-12-19

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

  15. Optical packaging activities at Institute of Microelectronics (IME), Singapore

    NASA Astrophysics Data System (ADS)

    Teo, Keng-Hwa; Sudharsanam, Krishnamachari; Pamidighantam, Ramana V.; Yeo, Yongkee; Iyer, Mahadevan K.

    2002-08-01

    The development of optoelectronic components for gigabit Ethernet communications is converging towards access networks where the cost of device makes a significant impact on the market acceptance. Device fabrication and packaging cost have to be brought down with novel assembly and packaging methods. Singapore has established a reputation in semiconductor device development and fabrication with excellent process and packaging facilities. Institute of Microelectronics (IME) was founded in 1991 to add value to the Singapore electronics industry. IME is involved in the development of active and passive photonics components using Silicon and polymer materials. We present a brief report on the development activities taking place in the field of optical component packaging at IME in recent years. We present a review of our competence and some of the optical device packaging activities that are being undertaken.

  16. Psychology: Development of the Young Child. Learning Package 2.

    ERIC Educational Resources Information Center

    Lee, Joan; And Others

    This instructional booklet is part of Learning Package #2 on self concept development and child behavior used in conjunction with the Child Development Training Program at Bemidji, Minnesota. The booklet is divided into 15 brief sections which emphasize: (1) techniques of observation and experimentation; (2) measurement of the readiness concept;…

  17. Partnerships with the Public Sector: Vocational Education Resource Package.

    ERIC Educational Resources Information Center

    Evaluation and Training Inst., Los Angeles, CA.

    Designed to assist community college administrators and faculty in enhancing vocational education programs and services, this resource package contains information on successful partnership programs between California Community Colleges (CCC) and public sector entities. Following a brief overview of public sector partnerships, the report presents…

  18. Smart packaging for photonics

    SciTech Connect

    Smith, J.H.; Carson, R.F.; Sullivan, C.T.; McClellan, G.; Palmer, D.W.

    1997-09-01

    Unlike silicon microelectronics, photonics packaging has proven to be low yield and expensive. One approach to make photonics packaging practical for low cost applications is the use of {open_quotes}smart{close_quotes} packages. {open_quotes}Smart{close_quotes} in this context means the ability of the package to actuate a mechanical change based on either a measurement taken by the package itself or by an input signal based on an external measurement. One avenue of smart photonics packaging, the use of polysilicon micromechanical devices integrated with photonic waveguides, was investigated in this research (LDRD 3505.340). The integration of optical components with polysilicon surface micromechanical actuation mechanisms shows significant promise for signal switching, fiber alignment, and optical sensing applications. The optical and stress properties of the oxides and nitrides considered for optical waveguides and how they are integrated with micromechanical devices were investigated.

  19. GENERAL PURPOSE ADA PACKAGES

    NASA Technical Reports Server (NTRS)

    Klumpp, A. R.

    1994-01-01

    Ten families of subprograms are bundled together for the General-Purpose Ada Packages. The families bring to Ada many features from HAL/S, PL/I, FORTRAN, and other languages. These families are: string subprograms (INDEX, TRIM, LOAD, etc.); scalar subprograms (MAX, MIN, REM, etc.); array subprograms (MAX, MIN, PROD, SUM, GET, and PUT); numerical subprograms (EXP, CUBIC, etc.); service subprograms (DATE_TIME function, etc.); Linear Algebra II; Runge-Kutta integrators; and three text I/O families of packages. In two cases, a family consists of a single non-generic package. In all other cases, a family comprises a generic package and its instances for a selected group of scalar types. All generic packages are designed to be easily instantiated for the types declared in the user facility. The linear algebra package is LINRAG2. This package includes subprograms supplementing those in NPO-17985, An Ada Linear Algebra Package Modeled After HAL/S (LINRAG). Please note that LINRAG2 cannot be compiled without LINRAG. Most packages have widespread applicability, although some are oriented for avionics applications. All are designed to facilitate writing new software in Ada. Several of the packages use conventions introduced by other programming languages. A package of string subprograms is based on HAL/S (a language designed for the avionics software in the Space Shuttle) and PL/I. Packages of scalar and array subprograms are taken from HAL/S or generalized current Ada subprograms. A package of Runge-Kutta integrators is patterned after a built-in MAC (MIT Algebraic Compiler) integrator. Those packages modeled after HAL/S make it easy to translate existing HAL/S software to Ada. The General-Purpose Ada Packages program source code is available on two 360K 5.25" MS-DOS format diskettes. The software was developed using VAX Ada v1.5 under DEC VMS v4.5. It should be portable to any validated Ada compiler and it should execute either interactively or in batch. The largest package

  20. The ZOOM minimization package

    SciTech Connect

    Fischler, Mark S.; Sachs, D.; /Fermilab

    2004-11-01

    A new object-oriented Minimization package is available for distribution in the same manner as CLHEP. This package, designed for use in HEP applications, has all the capabilities of Minuit, but is a re-write from scratch, adhering to modern C++ design principles. A primary goal of this package is extensibility in several directions, so that its capabilities can be kept fresh with as little maintenance effort as possible. This package is distinguished by the priority that was assigned to C++ design issues, and the focus on producing an extensible system that will resist becoming obsolete.

  1. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  4. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  6. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  8. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  9. 10 CFR 35.7 - FDA, other Federal, and State requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false FDA, other Federal, and State requirements. 35.7 Section 35.7 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Information § 35.7 FDA, other Federal, and State requirements. Nothing in this part relieves the licensee...

  10. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...

  12. 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. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  14. 21 CFR 830.220 - Termination of FDA service as an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency. 830.220 Section 830.220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... be likely to lead to a return of the conditions that prompted us to act. (b) If FDA has ended...

  15. 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].

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

    ERIC Educational Resources Information Center

    Jacobs, Robin Wills; King, James C.

    1977-01-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 1271.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA assign me a registration number? (a) FDA will assign each location a permanent registration number....

  18. The FDA and genetic testing: improper tools for a difficult problem

    PubMed Central

    Willmarth, Kirk

    2015-01-01

    The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry. PMID:27774193

  19. The FDA and genetic testing: improper tools for a difficult problem.

    PubMed

    Willmarth, Kirk

    2015-02-01

    The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA's traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA's proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.

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

    PubMed

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  1. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    PubMed Central

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets. PMID:26556207

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

    PubMed

    Rudenko, Larisa; Matheson, John C

    2007-01-01

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

  3. Developing Large CAI Packages.

    ERIC Educational Resources Information Center

    Reed, Mary Jac M.; Smith, Lynn H.

    1983-01-01

    When developing large computer-assisted instructional (CAI) courseware packages, it is suggested that there be more attentive planning to the overall package design before actual lesson development is begun. This process has been simplified by modifying the systems approach used to develop single CAI lessons, followed by planning for the…

  4. WASTE PACKAGE TRANSPORTER DESIGN

    SciTech Connect

    D.C. Weddle; R. Novotny; J. Cron

    1998-09-23

    The purpose of this Design Analysis is to develop preliminary design of the waste package transporter used for waste package (WP) transport and related functions in the subsurface repository. This analysis refines the conceptual design that was started in Phase I of the Viability Assessment. This analysis supports the development of a reliable emplacement concept and a retrieval concept for license application design. The scope of this analysis includes the following activities: (1) Assess features of the transporter design and evaluate alternative design solutions for mechanical components. (2) Develop mechanical equipment details for the transporter. (3) Prepare a preliminary structural evaluation for the transporter. (4) Identify and recommend the equipment design for waste package transport and related functions. (5) Investigate transport equipment interface tolerances. This analysis supports the development of the waste package transporter for the transport, emplacement, and retrieval of packaged radioactive waste forms in the subsurface repository. Once the waste containers are closed and accepted, the packaged radioactive waste forms are termed waste packages (WP). This terminology was finalized as this analysis neared completion; therefore, the term disposal container is used in several references (i.e., the System Description Document (SDD)) (Ref. 5.6). In this analysis and the applicable reference documents, the term ''disposal container'' is synonymous with ''waste package''.

  5. Project Information Packages: Overview.

    ERIC Educational Resources Information Center

    RMC Research Corp., Mountain View, CA.

    This brochure describes a new series of Project Information Packages, a U.S. Office of Education response to the need for a systematic approach to disseminating exemplary projects. The packages describe procedures for developing the necessary administrative support and management framework, as well as instructional methods and techniques. The six…

  6. Packaging issues: avoiding delamination.

    PubMed

    Hall, R

    2005-10-01

    Manufacturers can minimise delamination occurrence by applying the appropriate packaging design and process features. The end user can minimise the impact of fibre tear and reduce subsequent delamination by careful package opening. The occasional inconvenient delamination is a small price to pay for the high level of sterility assurance that comes with the use of Tyvek.

  7. (abstract) Electronic Packaging for Microspacecraft Applications

    NASA Technical Reports Server (NTRS)

    Wasler, David

    1993-01-01

    The intent of this presentation is to give a brief look into the future of electronic packaging for microspacecraft applications. Advancements in electronic packaging technology areas have developed to the point where a system engineer's visions, concepts, and requirements for a microspacecraft can now be a reality. These new developments are ideal candidates for microspacecraft applications. These technologies are capable of bringing about major changes in how we design future spacecraft while taking advantage of the benefits due to size, weight, power, performance, reliability , and cost. This presentation will also cover some advantages and limitations of surface mount technology (SMT), multichip modules (MCM), and wafer scale integration (WSI), and what is needed to implement these technologies into microspacecraft.

  8. The Radio Occultation Processing Package ROPP

    NASA Astrophysics Data System (ADS)

    Culverwell, I. D.; Lewis, H. W.; Offiler, D.; Marquardt, C.; Burrows, C. P.

    2015-01-01

    This paper describes the Radio Occultation Processing Package, ROPP, a product of the EUMETSAT Radio Occultation Meteorology Satellite Application Facility (ROM SAF) developed by a large number of scientists over many years. A brief review of the concepts, functionality and structure of ROPP is followed by more detailed descriptions of its key capabilities. Example results from a full chain of processing using some of the ROPP tools are presented. Some current and prospective uses of ROPP are given. Instructions on how to access the code and its supporting documentation are provided.

  9. The Radio Occultation Processing Package, ROPP

    NASA Astrophysics Data System (ADS)

    Culverwell, I. D.; Lewis, H. W.; Offiler, D.; Marquardt, C.; Burrows, C. P.

    2015-04-01

    This paper describes the Radio Occultation Processing Package, ROPP, a product of the EUMETSAT Radio Occultation Meteorology Satellite Application Facility (ROM SAF) developed by a large number of scientists over many years. A brief review of the concepts, functionality and structure of ROPP is followed by more detailed descriptions of its key capabilities. Example results from a full chain of processing using some of the ROPP tools are presented. Some current and prospective uses of ROPP are given. Instructions on how to access the code and its supporting documentation are provided.

  10. Packaging Concerns/Techniques for Large Devices

    NASA Technical Reports Server (NTRS)

    Sampson, Michael J.

    2009-01-01

    This slide presentation reviews packaging challenges and options for electronic parts. The presentation includes information about non-hermetic packages, space challenges for packaging and complex package variations.

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

    PubMed

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

    2012-10-01

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

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

    PubMed

    Yim, Seon-Hee; Chung, Yeun-Jun

    2014-12-01

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

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

    PubMed

    Laughren, Thomas P

    2010-09-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... Modernization Act.'' FDA is issuing this guidance to provide answers to common questions that might arise about... to common questions that might arise about the new fee provisions and FDA's plans for...

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

    PubMed

    Gaddis, Christine A

    2014-01-01

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

  16. AMAS Robotics Seminar Brief

    DTIC Science & Technology

    2011-07-19

    Unclassified Unclassified 19 July 2011 AMAS ROBOTICS SEMINAR BRIEF Aaron Hart, Product Integrator, RS JPO DISTRIBUTION STATEMENT A. Approved for...19-07-2011 to 19-07-2011 4. TITLE AND SUBTITLE robotics seminar brief 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6...12. DISTRIBUTION/AVAILABILITY STATEMENT Approved for public release; distribution unlimited 13. SUPPLEMENTARY NOTES AMAS ROBOTICS SEMINAR BRIEF 14

  17. STRUMPACK -- STRUctured Matrices PACKage

    SciTech Connect

    2014-12-01

    STRUMPACK - STRUctured Matrices PACKage - is a package for computations with sparse and dense structured matrix, i.e., matrices that exhibit some kind of low-rank property, in particular Hierarchically Semi Separable structure (HSS). Such matrices appear in many applications, e.g., FEM, BEM, Integral equations. etc. Exploiting this structure using certain compression algorithms allow for fast solution of linear systems and/or fast computation of matrix-vector products, which are the two main building blocks of matrix computations. STRUMPACK has presently two main components: a distributed-memory dense matrix computations package and a shared-memory sparse direct solver.

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

    PubMed

    Koski, Michelle E; Rovner, Eric S

    2014-02-01

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

  19. An analysis of FDA passive surveillance reports of seizures associated with consumption of aspartame.

    PubMed

    Tollefson, L; Barnard, R J

    1992-05-01

    Aspartame, the methyl ester of the dipeptide formed from combining phenylalanine and aspartic acid, was approved by the US Food and Drug Administration (FDA) in July 1981. FDA monitors complaints from consumers and health professionals through the Adverse Reaction Monitoring System, a passive surveillance program FDA has received 251 reports of seizures that have been linked to ingestion of aspartame by consumers. In most cases, information obtained from the complainants' medical records as well as data on consumption patterns, temporal relationships, and challenge tests did not support the claim that the occurrences of the seizures were linked to consumption of aspartame.

  20. Turning point or tipping point: new FDA draft guidances and the future of DTC advertising.

    PubMed

    Pitts, Peter J

    2004-01-01

    According to Food and Drug Administration (FDA) research, direct-to-consumer (DTC) drug ads are not as empowering as they were even three years ago. How will the FDA's new draft guidances reverse this trend and affect the future of DTC advertising? Will they be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative, or a tipping point with politicians and the public zeroing in on aggressively targeted DTC ads as the postimportation pharmaceutical bête noire? The FDA believes that its new guidances strengthen the strategic argument that a better-informed consumer lays the groundwork for a better potential customer.

  1. Science, law, and politics in FDA's genetically engineered foods policy: scientific concerns and uncertainties.

    PubMed

    Pelletier, David L

    2005-06-01

    The Food and Drug Administration's (FDA's) 1992 policy statement granted genetically engineered foods presumptive GRAS (generally recognized as safe) status. Since then, divergent views have been expressed concerning the scientific support for this policy. This paper examines four sources to better understand the basis for these claims: 1) internal FDA correspondence; 2) reports from the National Academy of Sciences; 3) research funded by US Department of Agriculture from 1981 to 2002; and 4) FDA's proposed rules issued in 2001. These sources reveal that little research has been conducted on unintended compositional changes from genetic engineering. Profiling techniques now make this feasible, but the new debate centers on the functional meaning of compositional changes.

  2. 78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ...; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled... CDRH and FDA. DATES: Submit either electronic or written comments on this guidance at any time....

  3. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

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

  4. Packaging for Posterity.

    ERIC Educational Resources Information Center

    Sias, Jim

    1990-01-01

    A project in which students designed environmentally responsible food packaging is described. The problem definition; research on topics such as waste paper, plastic, metal, glass, incineration, recycling, and consumer preferences; and the presentation design are provided. (KR)

  5. Electronic Packaging Techniques

    NASA Technical Reports Server (NTRS)

    1979-01-01

    A characteristic of aerospace system design is that equipment size and weight must always be kept to a minimum, even in small components such as electronic packages. The dictates of spacecraft design have spawned a number of high-density packaging techniques, among them methods of connecting circuits in printed wiring boards by processes called stitchbond welding and parallel gap welding. These processes help designers compress more components into less space; they also afford weight savings and lower production costs.

  6. Comparative Packaging Study

    NASA Technical Reports Server (NTRS)

    Perchonok, Michele H.; Oziomek, Thomas V.

    2009-01-01

    Future long duration manned space flights beyond low earth orbit will require the food system to remain safe, acceptable and nutritious. Development of high barrier food packaging will enable this requirement by preventing the ingress and egress of gases and moisture. New high barrier food packaging materials have been identified through a trade study. Practical application of this packaging material within a shelf life test will allow for better determination of whether this material will allow the food system to meet given requirements after the package has undergone processing. The reason to conduct shelf life testing, using a variety of packaging materials, stems from the need to preserve food used for mission durations of several years. Chemical reactions that take place during longer durations may decrease food quality to a point where crew physical or psychological well-being is compromised. This can result in a reduction or loss of mission success. The rate of chemical reactions, including oxidative rancidity and staling, can be controlled by limiting the reactants, reducing the amount of energy available to drive the reaction, and minimizing the amount of water available. Water not only acts as a media for microbial growth, but also as a reactant and means by which two reactants may come into contact with each other. The objective of this study is to evaluate three packaging materials for potential use in long duration space exploration missions.

  7. Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

    Cancer.gov

    This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

  8. 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.

  9. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    PubMed

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

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

    MedlinePlus

    ... Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it More ... information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety Information ...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and...

  12. Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.

    PubMed

    1998-02-02

    The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.

  13. FDA Approves 1st Direct-to-Consumer Genetic Risk Tests

    MedlinePlus

    ... 164507.html FDA Approves 1st Direct-to-Consumer Genetic Risk Tests They screen for gene variants linked ... on Thursday approved the first direct-to-consumer genetic health risk tests. Known as the 23andMe Personal ...

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

    PubMed

    Galarneau, Charlene

    2010-02-01

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

  15. Florida: State Policy Brief

    ERIC Educational Resources Information Center

    Corbett, Julie

    2015-01-01

    This brief is one in a series highlighting state policies, regulations, practices, laws, or other tools intended to create the necessary conditions for school and/or district turnaround. Each brief includes an overview of the relevant turnaround tool, its development process, its impact, and lessons learned that could assist other education…

  16. Lobby Day Issue Briefs.

    ERIC Educational Resources Information Center

    National Council of La Raza, Washington, DC. Office of Research Advocacy and Legislation.

    This compilation of seven briefs is intended to help citizens lobby United States senators, representatives, and their staff members on issues of importance to the Hispanic American community. Each brief synopsizes an issue, reviews current proposals for addressing the issue, and suggests the appropriate action that the member of congress should…

  17. Mississippi: State Policy Brief

    ERIC Educational Resources Information Center

    Corbett, Julie

    2014-01-01

    This brief is one in a series highlighting state policies, regulations, practices, laws, or other tools intended to create the necessary conditions for school and/or district turnaround. Each brief includes an overview of the relevant turnaround tool, its development process, its impact, and lessons learned that could assist other education…

  18. Brief Interventions for Adolescents

    PubMed Central

    Winters, Ken C

    2016-01-01

    Public health concerns regarding adolescent alcohol and other drug involvement emphasize the need for continuing research to develop and evaluate preventive interventions for use in a variety of settings. This focus includes research on brief interventions. This short commentary piece provides an overview of the brief intervention literature and highlights future directions PMID:27182561

  19. Erythrityl tetranitrate; drug efficacy study implementation; revocation of exemption; opportunity for a hearing--FDA. Notice.

    PubMed

    1998-06-23

    The Food and Drug Administration (FDA) is revoking the temporary exemption that has allowed single-entity coronary vasodilator drug products containing erythrityl tetranitrate to remain on the market beyond the time limits scheduled for implementation of the Drug Efficacy Study. FDA is announcing that the products lack substantial evidence of effectiveness and is offering an opportunity for a hearing on a proposal to withdraw approval of any applicable new drug applications (NDA's) or abbreviated new drug applications (ANDA's).

  20. Development of a FDA-Approved Pharmaceutical to Treat Noise-Induced Hearing Loss

    DTIC Science & Technology

    2014-08-13

    CONTRACT NUMBER: N62645-12-C-403 7 TITLE: Development of a FDA-Approved Pharmaceutical to Treat Noise-Induced Hearing Loss PRINCIPAL INVESTIGATOR...Development of a FDA-Approved Pharmaceutical to Treat Noise-Induced N62645-12-C-4037 Hearing Loss (NIHL) 5b. GRANT NUMBER 5c. PROGRAM ELEMENT...TERMS Noise-induced hearing loss, pharmaceutical , pre-clinical, animal studies 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF 18. NUMBER a. REPORT

  1. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions LLC

    2008-01-12

    The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package (also known as the "RH-TRU 72-B cask") and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: "...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." It further states: "...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) §71.8, "Deliberate Misconduct." Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, "Packaging and Transportation of Radioactive Material," certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, "Reporting of Defects and Noncompliance," regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a

  2. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2008-09-11

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the pplication." They further state: "each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) §71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  3. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2009-06-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) §71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  4. Reform at FDA: faster access to promising drugs? Food and Drug Administration.

    PubMed

    Baker, R

    1995-06-01

    The Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs, vaccines, and medical devices are safe and effective, is under hot debate by Congress, the Clinton administration, and the AIDS community. The Clinton/Gore proposal favors excluding drug and biologic manufacturers from requirements for more environmental assessments and only indirectly addresses drug development. Oregon Democratic Congressman Ron Wyden introduced an FDA reform bill which calls for the FDA to use expert panels, independent testing organizations, and institutional review boards (IRB) to help speed new drugs and devices through the approval process. The bill calls for the use of the IRB for the approval (or denial) of applications for Phase I review of new drugs. Not surprisingly, the AIDS community has differing views on the reform at the FDA. The Treatment Action Group (TAG), whose members hold key positions in well-known AIDS groups, supports the status quo at FDA and is lobbying AIDS organizations across the country to sign on to its FDA Reform Principles. Other AIDS treatment activists, such as members of ACT UP, favor local IRB jurisdiction over Phase I research.

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

    PubMed

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

    2016-05-01

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

  6. DIGITAL RADIOGRAPHY OF SPECIAL NUCLEAR MATERIAL TEST PACKAGES

    SciTech Connect

    HOWARD, BOYD

    2006-02-02

    The purpose of this document is to provide a brief introduction to digital radiography (DR), and a description of the DR configuration that was used to radiographically image the Special Nuclear Material (SNM) Test Packages before and after function tests that have been conducted. Also included are (1) Attachment 1, a comprehensive index that describes at which phase of the certification process that digital radiographic images were acquired, (2) digital radiographic images of each of the six packages at various stages of the certification process, and (3) Attachment 2, imaging instructions, that specify the setup procedures and detailed parameters of the DR imaging methodology that were used.

  7. CH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions LLC

    2005-02-28

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP charges the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) §71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.

  8. Food Packaging Materials

    NASA Technical Reports Server (NTRS)

    1978-01-01

    The photos show a few of the food products packaged in Alure, a metallized plastic material developed and manufactured by St. Regis Paper Company's Flexible Packaging Division, Dallas, Texas. The material incorporates a metallized film originally developed for space applications. Among the suppliers of the film to St. Regis is King-Seeley Thermos Company, Winchester, Ma'ssachusetts. Initially used by NASA as a signal-bouncing reflective coating for the Echo 1 communications satellite, the film was developed by a company later absorbed by King-Seeley. The metallized film was also used as insulating material for components of a number of other spacecraft. St. Regis developed Alure to meet a multiple packaging material need: good eye appeal, product protection for long periods and the ability to be used successfully on a wide variety of food packaging equipment. When the cost of aluminum foil skyrocketed, packagers sought substitute metallized materials but experiments with a number of them uncovered problems; some were too expensive, some did not adequately protect the product, some were difficult for the machinery to handle. Alure offers a solution. St. Regis created Alure by sandwiching the metallized film between layers of plastics. The resulting laminated metallized material has the superior eye appeal of foil but is less expensive and more easily machined. Alure effectively blocks out light, moisture and oxygen and therefore gives the packaged food long shelf life. A major packaging firm conducted its own tests of the material and confirmed the advantages of machinability and shelf life, adding that it runs faster on machines than materials used in the past and it decreases product waste; the net effect is increased productivity.

  9. Detecting small holes in packages

    DOEpatents

    Kronberg, J.W.; Cadieux, J.R.

    1996-03-19

    A package containing a tracer gas, and a method for determining the presence of a hole in the package by sensing the presence of the gas outside the package are disclosed. The preferred tracer gas, especially for food packaging, is sulfur hexafluoride. A quantity of the gas is added to the package and the package is closed. The concentration of the gas in the atmosphere outside the package is measured and compared to a predetermined value of the concentration of the gas in the absence of the package. A measured concentration greater than the predetermined value indicates the presence of a hole in the package. Measuring may be done in a chamber having a lower pressure than that in the package. 3 figs.

  10. Detecting small holes in packages

    DOEpatents

    Kronberg, James W.; Cadieux, James R.

    1996-01-01

    A package containing a tracer gas, and a method for determining the presence of a hole in the package by sensing the presence of the gas outside the package. The preferred tracer gas, especially for food packaging, is sulfur hexafluoride. A quantity of the gas is added to the package and the package is closed. The concentration of the gas in the atmosphere outside the package is measured and compared to a predetermined value of the concentration of the gas in the absence of the package. A measured concentration greater than the predetermined value indicates the presence of a hole in the package. Measuring may be done in a chamber having a lower pressure than that in the package.

  11. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2006-04-25

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package TransporterModel II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant| (WIPP) management and operating (M&O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations(CFR) §71.8. Any time a user suspects or has indications that the conditions ofapproval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  12. CH Packaging Program Guidance

    SciTech Connect

    None, None

    2007-12-13

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: "each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." They further state: "each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M&O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) §71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations are

  13. MMIC packaging with Waffleline

    NASA Astrophysics Data System (ADS)

    Perry, R. W.; Ellis, T. T.; Schineller, E. R.

    1990-06-01

    The design principle of Waffleline, a patented MMIC packaging technology, is discussed, and several recent applications are described and illustrated with drawings, diagrams, and photographs. Standard Waffleline is a foil-covered waffle-iron-like grid with dielectric-coated signal and power wires running in the channels and foil-removed holes for mounting prepackaged chips or chip carriers. With spacing of 50 mils between center conductors, this material is applicable at frequencies up to 40 GHz; EHF devices require Waffleline with 25-mil spacing. Applications characterized include a subassembly for a man-transportable SHF satellite-communication terminal, a transmitter driver for a high-power TWT, and a 60-GHz receiver front end (including an integrated monolithic microstrip antenna, a low-noise amplifier, a mixer, and an IF amplifier in a 0.25-inch-thick 1.6-inch-diameter package). The high package density and relatively low cost of Waffleline are emphasized.

  14. Ada Namelist Package

    NASA Technical Reports Server (NTRS)

    Klumpp, Allan R.

    1991-01-01

    Ada Namelist Package, developed for Ada programming language, enables calling program to read and write FORTRAN-style namelist files. Features are: handling of any combination of types defined by user; ability to read vectors, matrices, and slices of vectors and matrices; handling of mismatches between variables in namelist file and those in programmed list of namelist variables; and ability to avoid searching entire input file for each variable. Principle benefits derived by user: ability to read and write namelist-readable files, ability to detect most file errors in initialization phase, and organization keeping number of instantiated units to few packages rather than to many subprograms.

  15. SPHINX experimenters information package

    SciTech Connect

    Zarick, T.A.

    1996-08-01

    This information package was prepared for both new and experienced users of the SPHINX (Short Pulse High Intensity Nanosecond X-radiator) flash X-Ray facility. It was compiled to help facilitate experiment design and preparation for both the experimenter(s) and the SPHINX operational staff. The major areas covered include: Recording Systems Capabilities,Recording System Cable Plant, Physical Dimensions of SPHINX and the SPHINX Test cell, SPHINX Operating Parameters and Modes, Dose Rate Map, Experiment Safety Approval Form, and a Feedback Questionnaire. This package will be updated as the SPHINX facilities and capabilities are enhanced.

  16. Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

    PubMed

    KuKanich, Butch; Warner, Matt; Hahn, Kevin

    2017-02-01

    OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

  17. Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

    PubMed

    Weiss, Stephanie M; Smith-Simone, Stephanie Y

    2010-03-01

    Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting.

  18. AN ADA NAMELIST PACKAGE

    NASA Technical Reports Server (NTRS)

    Klumpp, A. R.

    1994-01-01

    The Ada Namelist Package, developed for the Ada programming language, enables a calling program to read and write FORTRAN-style namelist files. A namelist file consists of any number of assignment statements in any order. Features of the Ada Namelist Package are: the handling of any combination of user-defined types; the ability to read vectors, matrices, and slices of vectors and matrices; the handling of mismatches between variables in the namelist file and those in the programmed list of namelist variables; and the ability to avoid searching the entire input file for each variable. The principle user benefits of this software are the following: the ability to write namelist-readable files, the ability to detect most file errors in the initialization phase, a package organization that reduces the number of instantiated units to a few packages rather than to many subprograms, a reduced number of restrictions, and an increased execution speed. The Ada Namelist reads data from an input file into variables declared within a user program. It then writes data from the user program to an output file, printer, or display. The input file contains a sequence of assignment statements in arbitrary order. The output is in namelist-readable form. There is a one-to-one correspondence between namelist I/O statements executed in the user program and variables read or written. Nevertheless, in the input file, mismatches are allowed between assignment statements in the file and the namelist read procedure statements in the user program. The Ada Namelist Package itself is non-generic. However, it has a group of nested generic packages following the nongeneric opening portion. The opening portion declares a variety of useraccessible constants, variables and subprograms. The subprograms are procedures for initializing namelists for reading, reading and writing strings. The subprograms are also functions for analyzing the content of the current dataset and diagnosing errors. Two nested

  19. Energy: Conservation, Energy Briefs

    ERIC Educational Resources Information Center

    Nation's Schools and Colleges, 1975

    1975-01-01

    A comprehensive energy conservation program at College of the Holy Cross has saved nearly one-third of the fuel oil and one-fifth of the electricity used at the college; briefs on boilers, lights, design. (Author/MLF)

  20. Community Services Brief.

    ERIC Educational Resources Information Center

    ERIC Clearinghouse for Junior Colleges, Los Angeles, CA.

    This Brief reviews a variety of materials about two-year college community services programs. Specific topics include: their philosophy and definition, organization and administration, descriptions of noteworthy programs, and models for new community service programs. (Author/CK)

  1. Public Participation Guide: Briefings

    EPA Pesticide Factsheets

    Briefings are generally short presentations provided directly to community groups at their existing meetings or locations – such as social and civic clubs – to provide an overview or update on a project.

  2. Depleted Uranium: Technical Brief

    EPA Pesticide Factsheets

    This technical brief provides accepted data and references to additional sources for radiological and chemical characteristics, health risks and references for both the monitoring and measurement, and applicable treatment techniques for depleted uranium.

  3. Prescribing Brief Psychotherapy

    PubMed Central

    Schuyler, Dean

    2000-01-01

    Brief psychotherapy has demonstrated its effectiveness in treating emotional disorders and helping with problems that typically present to primary care physicians. Because practitioners receive little instruction about this treatment option and often have erroneous preconceived ideas about it, psychotherapy remains underprescribed. Effective brief therapy enables the patient to problem-solve, facilitates the relationship with the provider, and ultimately clarifies the patient's situation. Referral of appropriate patients for psychotherapy will enhance the effectiveness of the doctor in primary care. PMID:15014662

  4. Waste disposal package

    DOEpatents

    Smith, M.J.

    1985-06-19

    This is a claim for a waste disposal package including an inner or primary canister for containing hazardous and/or radioactive wastes. The primary canister is encapsulated by an outer or secondary barrier formed of a porous ceramic material to control ingress of water to the canister and the release rate of wastes upon breach on the canister. 4 figs.

  5. Radioactive waste disposal package

    DOEpatents

    Lampe, Robert F.

    1986-11-04

    A radioactive waste disposal package comprising a canister for containing vitrified radioactive waste material and a sealed outer shell encapsulating the canister. A solid block of filler material is supported in said shell and convertible into a liquid state for flow into the space between the canister and outer shell and subsequently hardened to form a solid, impervious layer occupying such space.

  6. Radioactive waste disposal package

    DOEpatents

    Lampe, Robert F.

    1986-01-01

    A radioactive waste disposal package comprising a canister for containing vitrified radioactive waste material and a sealed outer shell encapsulating the canister. A solid block of filler material is supported in said shell and convertible into a liquid state for flow into the space between the canister and outer shell and subsequently hardened to form a solid, impervious layer occupying such space.

  7. Automatic Differentiation Package

    SciTech Connect

    Gay, David M.; Phipps, Eric; Bratlett, Roscoe

    2007-03-01

    Sacado is an automatic differentiation package for C++ codes using operator overloading and C++ templating. Sacado provide forward, reverse, and Taylor polynomial automatic differentiation classes and utilities for incorporating these classes into C++ codes. Users can compute derivatives of computations arising in engineering and scientific applications, including nonlinear equation solving, time integration, sensitivity analysis, stability analysis, optimization and uncertainity quantification.

  8. Learning Activity Package, Algebra.

    ERIC Educational Resources Information Center

    Evans, Diane

    A set of ten teacher-prepared Learning Activity Packages (LAPs) in beginning algebra and nine in intermediate algebra, these units cover sets, properties of operations, number systems, open expressions, solution sets of equations and inequalities in one and two variables, exponents, factoring and polynomials, relations and functions, radicals,…

  9. YWCA Vocational Readiness Package.

    ERIC Educational Resources Information Center

    Scott, Jeanne

    This document outlines, in detail, the Vocational Readiness Package for young girls, which is a week-long program utilizing simulation games and role-playing, while employing peer group counseling techniques to dramatize the realities concerning women in marriage and careers today. After three years of using this program, the authors have compiled…

  10. Radiographic film package

    SciTech Connect

    Muylle, W. E.

    1985-08-27

    A radiographic film package for non-destructive testing, comprising a radiographic film sheet, an intensifying screen with a layer of lead bonded to a paper foil, and a vacuum heat-sealed wrapper with a layer of aluminum and a heat-sealed easy-peelable thermoplastic layer.

  11. Project Information Packages Kit.

    ERIC Educational Resources Information Center

    RMC Research Corp., Mountain View, CA.

    Presented are an overview booklet, a project selection guide, and six Project Information Packages (PIPs) for six exemplary projects serving underachieving students in grades k through 9. The overview booklet outlines the PIP projects and includes a chart of major project features. A project selection guide reviews the PIP history, PIP contents,…

  12. Packaging, transportation of LLW

    SciTech Connect

    Shelton, P.

    1994-12-31

    This presentation is an overview of the regulations and requirements for the packaging and transportation of low-level radioactive wastes. United States Environmental Protection Agency and Department of Transportation regulations governing the classification of wastes and the transport documentation are also described.

  13. Nutrition Learning Packages.

    ERIC Educational Resources Information Center

    World Health Organization, Geneva (Switzerland).

    This book presents nine packages of learning materials for trainers to use in teaching community health workers to carry out the nutrition element of their jobs. Lessons are intended to help health workers acquire skill in presenting to communities the principles and practice of good nutrition. Responding to the most common causes of poor…

  14. Jpetra Kernel Package

    SciTech Connect

    Heroux, Michael A.

    2004-03-01

    A package of classes for constructing and using distributed sparse and dense matrices, vectors and graphs, written in Java. Jpetra is intended to provide the foundation for basic matrix and vector operations for Java developers. Jpetra provides distributed memory operations via an abstract parallel machine interface. The most common implementation of this interface will be Java sockets.

  15. Electro-Microfluidic Packaging

    NASA Astrophysics Data System (ADS)

    Benavides, G. L.; Galambos, P. C.

    2002-06-01

    There are many examples of electro-microfluidic products that require cost effective packaging solutions. Industry has responded to a demand for products such as drop ejectors, chemical sensors, and biological sensors. Drop ejectors have consumer applications such as ink jet printing and scientific applications such as patterning self-assembled monolayers or ejecting picoliters of expensive analytes/reagents for chemical analysis. Drop ejectors can be used to perform chemical analysis, combinatorial chemistry, drug manufacture, drug discovery, drug delivery, and DNA sequencing. Chemical and biological micro-sensors can sniff the ambient environment for traces of dangerous materials such as explosives, toxins, or pathogens. Other biological sensors can be used to improve world health by providing timely diagnostics and applying corrective measures to the human body. Electro-microfluidic packaging can easily represent over fifty percent of the product cost and, as with Integrated Circuits (IC), the industry should evolve to standard packaging solutions. Standard packaging schemes will minimize cost and bring products to market sooner.

  16. Ensuring the safe and effective FDA regulation of fecal microbiota transplantation

    PubMed Central

    Sachs, Rachel E.; Edelstein, Carolyn A.

    2015-01-01

    Scientists, policymakers, and medical professionals alike have become increasingly worried about the rise of antibiotic resistance, and the growing number of infections due to bacteria like Clostridium difficile, which cause a significant number of deaths and are imposing increasing costs on our health care system. However, in the last few years, fecal microbiota transplantation (FMT), the transplantation of stool from a healthy donor into the bowel of a patient, has emerged as a startlingly effective means to treat recurrent C. difficile infections. At present, the FDA is proposing to regulate FMT as a biologic drug. However, this proposed classification is both underregulatory and overregulatory. The FDA's primary goal is to ensure that patients have access to safe, effective treatments—and as such they should regulate some aspects of FMT more stringently than they propose to, and others less so. This essay will examine the nature of the regulatory challenges the FDA will face in deciding to regulate FMT as a biologic drug, and will then evaluate available policy alternatives for the FDA to pursue, ultimately concluding that the FDA ought to consider adopting a hybrid regulatory model as it has done in the case of cord blood. PMID:27774199

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

    PubMed

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

    2014-01-01

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

  18. Credible deterrence: FDA and the Park Doctrine in the 21st century.

    PubMed

    O'Leary, Patrick

    2013-01-01

    One of FDA's most powerful enforcement tools is strict liability criminal prosecution of corporate officers under the Park Doctrine. Recent comments by high-ranking FDA officials about using this power more aggressively and recent cases apparently making good on this promise have spurred commentators to call for the doctrine's demise. Critics argue that strict liability for corporate officers violates fundamental notions of fairness and the appropriate relationship between guilt and liability in criminal law. As a response to these critics, this article argues that the Park Doctrine continues to serve a valuable purpose in deterring conduct that endangers the public health and that structural, political, and practical limitations on FDA's use of Park prosecutions have been, and will continue to be, effective protections against the abuses critics fear. This article proposes a model for understanding why and how FDA uses its prosecutorial powers and assesses a sample of recent high-profile prosecutions under this model to argue that the modern "escalation" of Park prosecutions is in fact a continuation of FDA's historical policy.

  19. High Efficiency Integrated Package

    SciTech Connect

    Ibbetson, James

    2013-09-15

    Solid-state lighting based on LEDs has emerged as a superior alternative to inefficient conventional lighting, particularly incandescent. LED lighting can lead to 80 percent energy savings; can last 50,000 hours – 2-50 times longer than most bulbs; and contains no toxic lead or mercury. However, to enable mass adoption, particularly at the consumer level, the cost of LED luminaires must be reduced by an order of magnitude while achieving superior efficiency, light quality and lifetime. To become viable, energy-efficient replacement solutions must deliver system efficacies of ≥ 100 lumens per watt (LPW) with excellent color rendering (CRI > 85) at a cost that enables payback cycles of two years or less for commercial applications. This development will enable significant site energy savings as it targets commercial and retail lighting applications that are most sensitive to the lifetime operating costs with their extended operating hours per day. If costs are reduced substantially, dramatic energy savings can be realized by replacing incandescent lighting in the residential market as well. In light of these challenges, Cree proposed to develop a multi-chip integrated LED package with an output of > 1000 lumens of warm white light operating at an efficacy of at least 128 LPW with a CRI > 85. This product will serve as the light engine for replacement lamps and luminaires. At the end of the proposed program, this integrated package was to be used in a proof-of-concept lamp prototype to demonstrate the component’s viability in a common form factor. During this project Cree SBTC developed an efficient, compact warm-white LED package with an integrated remote color down-converter. Via a combination of intensive optical, electrical, and thermal optimization, a package design was obtained that met nearly all project goals. This package emitted 1295 lm under instant-on, room-temperature testing conditions, with an efficacy of 128.4 lm/W at a color temperature of ~2873

  20. Food packaging history and innovations.

    PubMed

    Risch, Sara J

    2009-09-23

    Food packaging has evolved from simply a container to hold food to something today that can play an active role in food quality. Many packages are still simply containers, but they have properties that have been developed to protect the food. These include barriers to oxygen, moisture, and flavors. Active packaging, or that which plays an active role in food quality, includes some microwave packaging as well as packaging that has absorbers built in to remove oxygen from the atmosphere surrounding the product or to provide antimicrobials to the surface of the food. Packaging has allowed access to many foods year-round that otherwise could not be preserved. It is interesting to note that some packages have actually allowed the creation of new categories in the supermarket. Examples include microwave popcorn and fresh-cut produce, which owe their existence to the unique packaging that has been developed.

  1. Packaging legislation. Objectives and consequences.

    PubMed

    Christmann, H

    1995-05-01

    The recently published Directive on packaging and packaging waste makes new demands on the industry. This article highlights the key areas and raises some of the issues that must be confronted in the future.

  2. Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

    PubMed

    Leonard, Elizabeth Weeks

    2009-01-01

    On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

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

    PubMed

    Kesselheim, A S; Darrow, J J

    2015-01-01

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

  4. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.

    PubMed

    1998-11-12

    The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

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

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

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

  6. A new micromethod for the in vitro detection of antiplatelet antibodies: C-FDA thrombocytotoxicity

    SciTech Connect

    Lizak, G.E.; Grumet, F.C.

    1980-07-01

    A new microtechnique, C-FDA, for the in vitro detection of antiplatelet antibodies, is described. This technique is faster and simpler than either 51Cr thrombocytotoxicity or immunofluorescence (IF). C-FDA is more sensitive than 51Cr for all (anti-HLA, --P1A1, ABO, drug-related, and ITP-related) antibodies tested. Although IF was more sensitive for many types of antibodies, C-FDA was as good or better a clinical test method for all drug-related and isoimmune neonatal thrombocytopenia patient sera tested. Preliminary data also suggest that this method detects possible new non-HLA, non-ABO, nonP1A1 platelet antigens.

  7. Under the law, FDA must grant different standards for new dietary ingredients and food additives.

    PubMed

    Mister, Steven; Hathcock, John

    2012-04-01

    The FDA's draft Guidance on notifications for new dietary ingredients attempts to narrow the scope of "old" dietary ingredients that do not require notification to FDA and repeats some mistakes from the past by going beyond what is required or permitted by the Food, Drug & Cosmetic Act, as amended by the Dietary Supplements Health and Education Act of 1994. The draft Guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of "chemically altered" to include many changes that were not foreseen in the Congressional Record in 1994. Through these misinterpretations, FDA attempts to impose a food additives-like safety standard, and gain de facto premarket approval against the overt wishes of Congress.

  8. Use of field-portable XRF analyzers for rapid screening of toxic elements in FDA-regulated products.

    PubMed

    Palmer, Peter T; Jacobs, Richard; Baker, Peter E; Ferguson, Kelly; Webber, Siri

    2009-04-08

    Analytical instrumentation continues its amazing evolution, especially in regard to generating ever more sensitive, faster, and reliable measurements. Perhaps the most difficult challenges are making these instruments small enough to use in the field, equipping them with well-designed software that facilitates and simplifies their use by nonexperts while preserving enough of their analytical capabilities to render them useful for a wide variety of applications. Perhaps the most impressive and underappreciated example of instruments that meet these criteria are field-portable X-ray fluorescence (XRF) analyzers. In the past, these analyzers have been routinely used for environmental applications (lead in paint and soil, metal particulates in air samples collected onto filters), geology studies (ore and soil analysis, precious metal identification), and recycling industries (alloy identification). However, their use in the analysis of toxic elements in food, food ingredients, dietary supplements, and medicinal and herbal products, especially within the FDA and regulatory environments, has been surprisingly limited to date. Although XRF will not replace atomic spectrometry techniques such as ICP-MS for sub-parts per million level analyses, it offers a number of significant advantages including minimal sample preparation, high sample throughputs, rapid and definitive identification of many toxic elements, and accurate quantitative results. As should be obvious from many recent news reports on elevated levels of toxic elements in children's lunchboxes, toys, and supplements, field-portable XRF analyzers can fill a very important niche and are becoming increasingly popular for a wide variety of elemental analysis applications. This perspective begins with a brief review of the theory of XRF to highlight the underlying principle, instrumentation, and spectra. It includes a discussion of various analytical figures of merit of XRF to illustrate its strengths and limitations

  9. Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review.

    PubMed

    Tyner, Katherine; Sadrieh, Nakissa

    2011-01-01

    The Food and Drug Administration (FDA) does not, as yet, have specific guidances for products containing nanoscale materials. As announced in the report issued by the FDA Nanotechnology Task Force (July 2007), however, there are recommendations to various centers within the FDA to develop guidances for industry. Regardless of the lack of explicit FDA guidances, there are therapeutics currently on the market containing nanoscale materials, and additional novel nanomaterial-containing therapeutics are being developed with the hopes of being submitted for regulatory review and approval. While, for the most part, these novel nanomaterial-containing products are being evaluated using the same regulatory requirements as products that do not contain nanomaterials, it is increasingly evident that at least in the area of characterization of nanomaterials used in drug products, there may be areas where special focus is needed. Specific areas include the validity of applying small molecule principles and methodologies to nanomaterial-containing products, the effects the nanomaterial will impart to the rest of the formulation (or vice versa), and how the physicochemical properties may be impacted by biological settings. Similarly, for safety evaluation, biodistribution studies will be at the core of any evaluation of products containing nanomaterials. These biodistribution studies will, in effect, be indicative of where the nanoparticles are traveling and possibly accumulating, therefore subjecting those sites to increased likelihood of toxicological effects. This chapter focuses on questions and considerations that may arise for sponsors during product characterization, as well as considerations for the appropriate design and conduct of in vivo toxicology studies. This chapter will also review how current FDA guidances apply to nanotherapeutics.This chapter reflects the current thinking and experience of the authors. However, this is not a policy document and should not be

  10. Prescribing of FDA-approved and compounded hormone therapy differs by specialty

    PubMed Central

    Constantine, Ginger D.; Archer, David F.; Graham, Shelli; Bernick, Brian A.; Mirkin, Sebastian

    2016-01-01

    Abstract Objective: To determine the prescribing patterns of general practitioners (GPs), obstetrician/gynecologists (OB/GYNs), and wellness physicians (WPs) of menopausal hormone therapy (HT) for both compounded (CHT) and Food and Drug Administration (FDA)-approved products, using a survey of US physicians. Methods: Nine thousand one US physicians were invited to participate in a survey to report on their HT-prescribing patterns. Physicians were eligible if they prescribed HT for at least six patients per month. Results: The survey was completed by 440 eligible physicians (893 responded of 9,001 invited) including 171 GPs, 170 OB/GYNs, and 84 WPs. Physicians prescribed HT for 15% to 30% of their female patients, with WPs numerically most likely to prescribe HT. Menopausal symptoms were the leading reason for HT prescriptions among all specialties. WPs seemed more likely to prescribe HT for general/cardiovascular health (28%), and for shorter durations, than other specialties. WPs prescribed proportionally more compounded (vs FDA-approved) estrogens/progestogens than GPs or OB/GYNs, but OB/GYNs seemed to prescribe more compounded dehydroepiandrosterone and testosterone (prescribed alone) than did others. OB/GYNs seemed least likely to consider CHT being more safe or effective than FDA-approved HT. Symptom relief was the main determinant of efficacy for all specialties; WPs also used blood (61%) or saliva testing (25%) for dose adjustment. Conclusions: Although all physician specialties surveyed prescribed HT, differences in prescribing CHT versus FDA-approved formulations by medical specialty/practice seemed to exist. Of those surveyed, OB/GYNs and GPs prescribed proportionally more FDA-approved HT, whereas WPs, similarly, prescribed more CHT. More discussion is needed concerning physicians’ decisions to prescribe CHT versus FDA-approved formulations. PMID:27648594

  11. Sustainable Library Development Training Package

    ERIC Educational Resources Information Center

    Peace Corps, 2012

    2012-01-01

    This Sustainable Library Development Training Package supports Peace Corps' Focus In/Train Up strategy, which was implemented following the 2010 Comprehensive Agency Assessment. Sustainable Library Development is a technical training package in Peace Corps programming within the Education sector. The training package addresses the Volunteer…

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

    PubMed

    Ridge, John R; Statz, Sandra

    2015-01-01

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

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

    PubMed

    Lykken, Sara

    2013-01-01

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

  14. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    Cancer.gov

    The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

  15. Anticounterfeit packaging technologies

    PubMed Central

    Shah, Ruchir Y.; Prajapati, Prajesh N.; Agrawal, Y. K.

    2010-01-01

    Packaging is the coordinated system that encloses and protects the dosage form. Counterfeit drugs are the major cause of morbidity, mortality, and failure of public interest in the healthcare system. High price and well-known brands make the pharma market most vulnerable, which accounts for top priority cardiovascular, obesity, and antihyperlipidemic drugs and drugs like sildenafil. Packaging includes overt and covert technologies like barcodes, holograms, sealing tapes, and radio frequency identification devices to preserve the integrity of the pharmaceutical product. But till date all the available techniques are synthetic and although provide considerable protection against counterfeiting, have certain limitations which can be overcome by the application of natural approaches and utilization of the principles of nanotechnology. PMID:22247875

  16. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions, LLC

    2003-08-25

    The purpose of this program guidance document is to provide technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the SARP and/or C of C shall govern. The C of C states: ''...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, ''Operating Procedures,'' of the application.'' It further states: ''...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, ''Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC approved, users need to be familiar with 10 CFR {section} 71.11, ''Deliberate Misconduct.'' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the RH-TRU 72-B packaging. This Program Guidance standardizes instructions for all users. Users shall follow these instructions. Following these instructions assures that operations are safe and meet the requirements of the SARP. This document is available on the Internet at: ttp://www.ws/library/t2omi/t2omi.htm. Users are responsible for ensuring they are using the current revision and change notices. Sites may prepare their own document using the word

  17. TIDEV: Tidal Evolution package

    NASA Astrophysics Data System (ADS)

    Cuartas-Restrepo, P.; Melita, M.; Zuluaga, J.; Portilla, B.; Sucerquia, M.; Miloni, O.

    2016-09-01

    TIDEV (Tidal Evolution package) calculates the evolution of rotation for tidally interacting bodies using Efroimsky-Makarov-Williams (EMW) formalism. The package integrates tidal evolution equations and computes the rotational and dynamical evolution of a planet under tidal and triaxial torques. TIDEV accounts for the perturbative effects due to the presence of the other planets in the system, especially the secular variations of the eccentricity. Bulk parameters include the mass and radius of the planet (and those of the other planets involved in the integration), the size and mass of the host star, the Maxwell time and Andrade's parameter. TIDEV also calculates the time scale that a planet takes to be tidally locked as well as the periods of rotation reached at the end of the spin-orbit evolution.

  18. Fair Package Assignment

    NASA Astrophysics Data System (ADS)

    Lahaie, Sébastien; Parkes, David C.

    We consider the problem of fair allocation in the package assignment model, where a set of indivisible items, held by single seller, must be efficiently allocated to agents with quasi-linear utilities. A fair assignment is one that is efficient and envy-free. We consider a model where bidders have superadditive valuations, meaning that items are pure complements. Our central result is that core outcomes are fair and even coalition-fair over this domain, while fair distributions may not even exist for general valuations. Of relevance to auction design, we also establish that the core is equivalent to the set of anonymous-price competitive equilibria, and that superadditive valuations are a maximal domain that guarantees the existence of anonymous-price competitive equilibrium. Our results are analogs of core equivalence results for linear prices in the standard assignment model, and for nonlinear, non-anonymous prices in the package assignment model with general valuations.

  19. Software packager user's guide

    NASA Technical Reports Server (NTRS)

    Callahan, John R.

    1995-01-01

    Software integration is a growing area of concern for many programmers and software managers because the need to build new programs quickly from existing components is greater than ever. This includes building versions of software products for multiple hardware platforms and operating systems, building programs from components written in different languages, and building systems from components that must execute on different machines in a distributed network. The goal of software integration is to make building new programs from existing components more seamless -- programmers should pay minimal attention to the underlying configuration issues involved. Libraries of reusable components and classes are important tools but only partial solutions to software development problems. Even though software components may have compatible interfaces, there may be other reasons, such as differences between execution environments, why they cannot be integrated. Often, components must be adapted or reimplemented to fit into another application because of implementation differences -- they are implemented in different programming languages, dependent on different operating system resources, or must execute on different physical machines. The software packager is a tool that allows programmers to deal with interfaces between software components and ignore complex integration details. The packager takes modular descriptions of the structure of a software system written in the package specification language and produces an integration program in the form of a makefile. If complex integration tools are needed to integrate a set of components, such as remote procedure call stubs, their use is implied by the packager automatically and stub generation tools are invoked in the corresponding makefile. The programmer deals only with the components themselves and not the details of how to build the system on any given platform.

  20. Aquaculture information package

    SciTech Connect

    Boyd, T.; Rafferty, K.

    1998-08-01

    This package of information is intended to provide background information to developers of geothermal aquaculture projects. The material is divided into eight sections and includes information on market and price information for typical species, aquaculture water quality issues, typical species culture information, pond heat loss calculations, an aquaculture glossary, regional and university aquaculture offices and state aquaculture permit requirements. A bibliography containing 68 references is also included.

  1. Trilinos Web Interface Package

    SciTech Connect

    Hu, Jonathan; Phenow, Michael N.; Sala, Marzio; Tuminaro, Ray S.

    2006-09-01

    WebTrilinos is a scientific portal, a web-based environment to use several Trilinos packages through the web. If you are a teaching sparse linear algebra, you can use WebTrilinos to present code snippets and simple scripts, and let the students execute them from their browsers. If you want to test linear algebra solvers, you can use the MatrixPortal module, and you just have to select problems and options, then plot the results in nice graphs.

  2. 78 FR 19007 - Certain Products Having Laminated Packaging, Laminated Packaging, and Components Thereof...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... COMMISSION Certain Products Having Laminated Packaging, Laminated Packaging, and Components Thereof.... 1337, on behalf of Lamina Packaging Innovations LLC of Longview, Texas. An amended complaint was filed... importation of certain products having laminated packaging, laminated packaging, and components thereof...

  3. 21 CFR 355.20 - Packaging conditions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per... packages shall not contain more than 120 mg total fluorine per package. (3) Exception. Package...

  4. 21 CFR 355.20 - Packaging conditions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per... packages shall not contain more than 120 mg total fluorine per package. (3) Exception. Package...

  5. 21 CFR 355.20 - Packaging conditions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per... packages shall not contain more than 120 mg total fluorine per package. (3) Exception. Package...

  6. 21 CFR 355.20 - Packaging conditions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per... packages shall not contain more than 120 mg total fluorine per package. (3) Exception. Package...

  7. NASA educational briefs

    NASA Technical Reports Server (NTRS)

    Vogt, G. L.

    1982-01-01

    In response to a large public demand for information, the Educational Services Branch of NASA has undertaken a series of publications designed for use by teachers, titled 'Educational Briefs for the Classroom', which has resulted in six to eight issues each year for the last three years. Typical of the topics to which the series is dedicated have been space suits, manned spaceflight mission summaries, solar cells, planetary encounter data, orbits, and rocketry. The planning committee for Educational Briefs is aided in its selection of topics by the many letters received by NASA. Following the Voyager Saturn flybys, NASA received more than 175,000 letters from both children and adults.

  8. Optimal segmentation and packaging process

    DOEpatents

    Kostelnik, Kevin M.; Meservey, Richard H.; Landon, Mark D.

    1999-01-01

    A process for improving packaging efficiency uses three dimensional, computer simulated models with various optimization algorithms to determine the optimal segmentation process and packaging configurations based on constraints including container limitations. The present invention is applied to a process for decontaminating, decommissioning (D&D), and remediating a nuclear facility involving the segmentation and packaging of contaminated items in waste containers in order to minimize the number of cuts, maximize packaging density, and reduce worker radiation exposure. A three-dimensional, computer simulated, facility model of the contaminated items are created. The contaminated items are differentiated. The optimal location, orientation and sequence of the segmentation and packaging of the contaminated items is determined using the simulated model, the algorithms, and various constraints including container limitations. The cut locations and orientations are transposed to the simulated model. The contaminated items are actually segmented and packaged. The segmentation and packaging may be simulated beforehand. In addition, the contaminated items may be cataloged and recorded.

  9. Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

    PubMed

    Sage, Adam; Blalock, Susan J; Carpenter, Delesha

    This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications.

  10. 21 CFR 1271.3 - How does FDA define important terms in this part?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS General Provisions § 1271.3 How does FDA... use means the implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered. (b) Establishment means a place...

  11. Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels.

    PubMed

    Chang, Yang; Burckart, Gilbert J; Lesko, Lawrence J; Dowling, Thomas C

    2013-09-01

    Pharmacokinetic (PK) studies in patients with liver disease are an important clinical pharmacology component of drug development. In 2003, FDA released the guidance for industry on "Pharmacokinetics in Patients with Impaired Hepatic Function," which provides recommendations to sponsors on study design, data analysis, and impact on dosing and labeling. We evaluated the quality and consistency of hepatic dosing recommendations, and compared contemporary clinical practice of dosing in patients with impaired hepatic function with product labels. All new molecular entities (NME) and labels approved by the FDA during the period of January 2004 to December 2011 were reviewed. The fraction of the dose hepatically eliminated, quality of hepatic impairment PK studies reported, and any dose recommendations provided in the label and in a tertiary clinical reference (Micromedex) were reviewed. Out of 157 NMEs, 67 met the criteria for evaluation of dosing in hepatic disease. Problem areas were identified related to the lack of specific hepatic metabolism information in 90% of FDA-approved labels, inconsistent terminology, and "use with caution in liver disease" in 27% of NME. Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners.

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... means. It is in any event to be filed with the Division of Dockets Management not less than 15 days... open session. After approval, the minutes are to be forwarded to the Division of Dockets Management and... involved is to apply the principles relating to conflicts of interest that FDA uses in establishing...

  13. Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights July-September 2016.

    PubMed

    Rubio, Teresa

    2016-12-01

    The FDA's MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. Search of Drug Safety Labeling Changes (SLC) database was conducted on October 10, 2016 for date range "7/1/2016-9/30/2016", labeling section "Boxed Warning". These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. (Drug Safety Labeling Changes are available at: http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery.) Boxed warnings are ordinarily used to highlight either: adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; OR serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... confirming or revoking the detention by noon on the fifth calendar day after the appeal is filed; after your... final decision within the 5-calendar day period after the appeal is filed. If FDA either fails to... detention order within the 5-calendar day period, the detention order is deemed terminated. (b) If...

  15. 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.

  16. 21 CFR 830.100 - FDA accreditation of an issuing agency.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100 Section 830.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... according to a single set of consistent, fair, and reasonable terms and conditions. (5) Will protect...

  17. The rosiglitazone decision process at FDA and EMA. What should we learn?

    PubMed

    Pouwels, Koen B; van Grootheest, Kees

    2012-01-01

    In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased risk of ischemic heart disease. It is often stated that the first signs of an increased risk of ischemic heart disease were noticed in 2004, however already in 2001 the FDA concluded, based on data available to the EMA at the time of initial approval, that rosiglitazone should not be used in combination with insulin, because this combination therapy was associated with an increased risk of cardiac failure and ischemic heart disease. Remarkably, in 2007, when the evidence against this combination therapy had increased, the EMA made a decision that encouraged the use of insulin in combination with rosiglitazone, while the FDA tried to restrict this combination therapy. Despite the publication of several studies, including a large randomized controlled study, the cardiovascular risk of rosiglitazone still has not been definitively established. The weight given to the benefits and the risks seems mainly a subjective decision. To prevent new cases like rosiglitazone, more attention should be given to evaluation of study protocols of safety trials prior to their starts. This paper gives a critical overview of the decision making process at the FDA and the EMA on the basis of public available information.

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

    PubMed

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

    2014-10-01

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

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

    PubMed

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

    2014-02-06

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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  1. 21 CFR 807.100 - FDA action on a premarket notification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL...) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be... information, including clinical data if deemed necessary by the Commissioner, that demonstrates that...

  2. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... employee of FDA may order the detention of any article of food that is found during an inspection... the article of food is adulterated or misbranded....

  3. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  4. 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.

  5. Applying the FDA definition of whole grains to the evidence for cardiovascular disease health claims.

    PubMed

    De Moura, Fabiana F; Lewis, Kara D; Falk, Michael C

    2009-11-01

    The U.S. FDA defines whole grains as consisting of the intact, ground, cracked, or flaked fruit of the grains whose principal components, the starchy endosperm, germ, and bran, are present in the same relative proportions as they exist in the intact grain. We evaluated the effect of applying the FDA definition of whole grains to the strength of scientific evidence in support of claims for risk reduction of cardiovascular disease (CVD). We concluded that using the FDA definition for whole grains as a selection criterion is limiting, because the majority of existing studies often use a broader meaning to define whole grains. When considering only whole grain studies that met the FDA definition, we found insufficient scientific evidence to support a claim that whole grain intake reduces the risk of CVD. However, a whole grain and reduced risk of CVD health claim is supported when using a broader concept of whole grain to include studies that considered intake of fiber-rich bran and germ as well as whole grain. This type of analysis is complicated by diversity in nutrients and bioactive components among different types of whole grains.

  6. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical... comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug... http://www.regulations.gov . Submit written comments to the Division of Dockets Management...

  7. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Utilization of an advisory committee on the... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... pose significant safety hazards, or which present narrow benefit-risk considerations requiring a...

  8. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... pose significant safety hazards, or which present narrow benefit-risk considerations requiring a...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Utilization of an advisory committee on the... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... pose significant safety hazards, or which present narrow benefit-risk considerations requiring a...

  10. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Utilization of an advisory committee on the... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any... pose significant safety hazards, or which present narrow benefit-risk considerations requiring a...

  11. ADVERSE PRE- AND POSTNATAL EVENTS REPORTED TO FDA IN ASSOCIATION WITH MATERNAL ATENOLOL TREATMENT IN PREGNANCY

    EPA Science Inventory

    Atenolol is a beta-adrenoreceptor blocker used for treatment of hypertension in pregnancy. This study evaluates the reporting frequency of adverse pre- and postnatal outcomes in a series of 70 cases of maternal exposure during gestation, derived from 140 reports to FDA with Ateno...

  12. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements... dosage directions. 10. A graphic appears at the bottom of the first panel leading the reader to the...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements... dosage directions. 10. A graphic appears at the bottom of the first panel leading the reader to the...

  14. 21 CFR Appendix B to Part 101 - Graphic Enhancements Used by the FDA

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements... dosage directions. 10. A graphic appears at the bottom of the first panel leading the reader to the...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  18. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Graphic Enhancements Used by the FDA B Appendix B to Part 101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Pt. 101, App. B Appendix B to Part...

  20. 21 CFR 1271.3 - How does FDA define important terms in this part?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS General Provisions § 1271.3 How does FDA... use means the implantation, transplantation, infusion, or transfer of human cells or tissue back...

  1. 21 CFR 1271.3 - How does FDA define important terms in this part?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS General Provisions § 1271.3 How does FDA... use means the implantation, transplantation, infusion, or transfer of human cells or tissue back...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  3. 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.

  4. 21 CFR 1.379 - How long may FDA detain an article of food?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379 Section 1.379 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  5. Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning

    ERIC Educational Resources Information Center

    Taylor, Christy Marie

    2013-01-01

    In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Product Development. 7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory meeting, BPD Type... detail of the data should be appropriate to the meeting type requested and the product development stage... formal meetings between FDA and sponsors or applicants relating to the development and review...

  7. DMSO, Hobby Shops and the FDA: The Diffusion of a Health Policy Dilemma.

    ERIC Educational Resources Information Center

    Weinstock, Edward; Davis, Phillip

    1985-01-01

    Despite being banned by the FDA, DMSO (dimethyl sulfoxide) usage has spread rapidly among arthritic victims and weekend athletes. This study looked at current and past users to learn how they discovered DMSO, their reactions to buying an illegal drug, and possible implications for public health policy. (MT)

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

    MedlinePlus

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

  9. The 2009 Legislative Briefing

    ERIC Educational Resources Information Center

    Gaines, Gale F., Comp.

    2009-01-01

    "The 2009 Legislative Briefing" is a topical summary of actions during the 2009 legislative sessions that affect education in the 16 SREB states. Topics include: state budgets and the economy; tax and revenue; teacher and faculty pay raises; retirement systems; issues affecting teachers and education leaders; health and safety;…

  10. Poverty. Research Brief

    ERIC Educational Resources Information Center

    Walker, Karen

    2007-01-01

    How many people reading this brief believes they could financially survive in a household of four people on $19,784 a year? Yet, this was the official poverty threshold as determined by the federal government for 2005. During this same year, 17% of children under 18 lived below the poverty line, of which 14% were white, 11% Asian, 28% Hispanic and…

  11. Superintendent's Briefing Book, 2011

    ERIC Educational Resources Information Center

    Educational Research Service, 2010

    2010-01-01

    The "2011 Superintendent's Briefing Book" provides comprehensive yet concise overviews of the best thinking available on a wide range of top-priority PreK-12 education concerns. This resource will prove invaluable in making research-based decisions with confidence, and in identifying programs and practices that will improve student achievement.…

  12. Research in Brief.

    ERIC Educational Resources Information Center

    Journalism Quarterly, 1984

    1984-01-01

    Brief research reports discuss Latin America as seen on United States network television; television news coverage of federal regulatory agencies; community perceptions of media impressions; active television viewing and cultivation hypothesis; the impact of cable on traditional television news viewing; George Kibbe Turner; advertising; and…

  13. Research in Brief.

    ERIC Educational Resources Information Center

    Journalism Quarterly, 1980

    1980-01-01

    Eight brief research reports concerning a newspaper's conversion to VDTs, media evaluation by police chiefs, defending and indemnifying reporters in tort actions, newsmagazine coverage of the Supreme Court, pricing of advertising in weekly newspapers, the importance of writing, "yeasaying" in readership surveys, and public service utilization by…

  14. Academic Bankruptcy. Policy Brief.

    ERIC Educational Resources Information Center

    Anderson, Amy Berk; Lewis, Anne C.

    In an effort to improve student achievement in low-performing districts, 22 states have developed academic bankruptcy laws, allowing them to intervene in districts that consistently fail to satisfy state education performance standards. This policy brief presents an overview of these statutes. The text offers a comparative summary of state…

  15. Research in Brief.

    ERIC Educational Resources Information Center

    Journalism Quarterly, 1982

    1982-01-01

    Offers brief descriptions of research concerning (1) media bias toward business, (2) foreign affairs coverage in elite and mass periodicals, (3) how emphasis on people affects coverage of crime, (4) antisocial and prosocial behavior on prime-time television, (5) network news coverage of Iran, and (6) magazines' reporting on insects. (FL)

  16. Issue Brief on Diversity

    ERIC Educational Resources Information Center

    Division on Developmental Disabilities, Council for Exceptional Children (NJ1), 2013

    2013-01-01

    During the past year, the Diversity Committee of the Division of Developmental Disabilities (DDD) Board worked with the Board and the Issues Committee Chair to develop an issue brief addressing diversity, its impact on the membership and the wider community that is served by the work of DDD, resulting in recommendations that will influence policy…

  17. A Brief History.

    ERIC Educational Resources Information Center

    Yalouris, Nicolaos

    1996-01-01

    Provides a brief but concise overview of the historical development of the Olympic Games in ancient Greece. Originally conceived as a one day, single-race event, the Games grew to the point where they represented an apotheosis of Greek culture. Discusses the role played by conflict within the city-states. (MJP)

  18. Informatics: A Brief Survey.

    ERIC Educational Resources Information Center

    He, Shaoyi

    2003-01-01

    Provides a brief survey of informatics, defined as the application of information technology to various fields, with respect to its historical background, disciplinary identity, fundamental aspects, applications, and challenges. Highlights include biological, clinical, dental, environmental, geomatics, health, legal, management, medical, museum,…

  19. Use of surrogate outcomes in US FDA drug approvals, 2003–2012: a survey

    PubMed Central

    Yu, Tsung; Hsu, Yea-Jen; Fain, Kevin M; Boyd, Cynthia M; Holbrook, Janet T; Puhan, Milo A

    2015-01-01

    Objective To evaluate, across a spectrum of diseases, how often surrogate outcomes are used as a basis for drug approvals by the US Food and Drug Administration (FDA), and whether and how the rationale for using treatment effects on surrogates as predictors of treatment effects on patient-centred outcomes is discussed. Study design and setting We used the Drugs@FDA website to identify drug approvals produced from 2003 to 2012 by the FDA. We focused on four diseases (chronic obstructive pulmonary disease (COPD), type 1 or 2 diabetes, glaucoma and osteoporosis) for which surrogates are commonly used in trials. We reviewed the drug labels and medical reviews to provide empirical evidence on how surrogate outcomes are handled by the FDA. Results Of 1043 approvals screened, 58 (6%) were for the four diseases of interest. Most drugs for COPD (7/9, 78%), diabetes (26/26, 100%) and glaucoma (9/9, 100%) were approved based on surrogates while for osteoporosis, most drugs (10/14, 71%) were also approved for patient-centred outcomes (fractures). The rationale for using surrogates was discussed in 11 of the 43 (26%) drug approvals based on surrogates. In these drug approvals, we found drug approvals for diabetes are more likely than the other examined conditions to contain a discussion of trial evidence demonstrating that treatment effects on surrogate outcomes predict treatment effects on patient-centred outcomes. Conclusions Our results suggest that the FDA did not use a consistent approach to address surrogates in assessing the benefits and harms of drugs for COPD, type 1 or 2 diabetes, glaucoma and osteoporosis. For evaluating new drugs, patient-centred outcomes should be chosen whenever possible. If the use of surrogate outcomes is necessary, then a consistent approach is important to review the evidence for surrogacy and consider surrogate's usage in the treatment and population under study. PMID:26614616

  20. 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.

  1. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    PubMed

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care.

  2. From Bench to FDA to Bedside: US Regulatory Trends for New Stem Cell Therapies

    PubMed Central

    Knoepfler, Paul S.

    2015-01-01

    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

  3. Repositioning FDA-Approved Drugs in Combination with Epigenetic Drugs to Reprogram Colon Cancer Epigenome.

    PubMed

    Raynal, Noël J-M; Da Costa, Elodie M; Lee, Justin T; Gharibyan, Vazganush; Ahmed, Saira; Zhang, Hanghang; Sato, Takahiro; Malouf, Gabriel G; Issa, Jean-Pierre J

    2017-02-01

    Epigenetic drugs, such as DNA methylation inhibitors (DNMTi) or histone deacetylase inhibitors (HDACi), are approved in monotherapy for cancer treatment. These drugs reprogram gene expression profiles, reactivate tumor suppressor genes (TSG) producing cancer cell differentiation and apoptosis. Epigenetic drugs have been shown to synergize with other epigenetic drugs or various anticancer drugs. To discover new molecular entities that enhance epigenetic therapy, we performed a high-throughput screening using FDA-approved libraries in combination with DNMTi or HDACi. As a screening model, we used YB5 system, a human colon cancer cell line, which contains an epigenetically silenced CMV-GFP locus, mimicking TSG silencing in cancer. CMV-GFP reactivation is triggered by DNMTi or HDACi and responds synergistically to DNMTi/HDACi combination, which phenocopies TSG reactivation upon epigenetic therapy. GFP fluorescence was used as a quantitative readout for epigenetic activity. We discovered that 45 FDA-approved drugs (4% of all drugs tested) in our FDA-approved libraries enhanced DNMTi and HDACi activity, mainly belonging to anticancer and antiarrhythmic drug classes. Transcriptome analysis revealed that combination of decitabine (DNMTi) with the antiarrhythmic proscillaridin A produced profound gene expression reprogramming, which was associated with downregulation of 153 epigenetic regulators, including two known oncogenes in colon cancer (SYMD3 and KDM8). Also, we identified about 85 FDA-approved drugs that antagonized DNMTi and HDACi activity through cytotoxic mechanisms, suggesting detrimental drug interactions for patients undergoing epigenetic therapy. Overall, our drug screening identified new combinations of epigenetic and FDA-approved drugs, which can be rapidly implemented into clinical trials. Mol Cancer Ther; 16(2); 397-407. ©2016 AACR.

  4. BOK-Underfill Optimization for FPGA Package/Assembly

    NASA Technical Reports Server (NTRS)

    Ghaffarian, Reza

    2011-01-01

    Commercial-off-the-shelf area array package technologies in high-reliability versions are being considered for NASA electronic systems. These packages are prone to early failure due to the severe mechanical shock and vibration of launch, as well as other less severe conditions, such as mechanical loading during descent, rough terrain mobility, handling, and ground tests. As the density of these packages increases and the size of ball interconnections decrease, susceptibility to mechanical loading and cycling fatigue grows. This report presents a summary of the body of knowledge developed for the evaluation of area array packages and is based on surveys of literature from industry and academia. For high-reliability applications, the limited data that exists will be presented. Most data from industry deals with mechanical fatigue caused by four-point bend tests, as well as from drop tests for hand-held electronics; the most recent data will be presented, along with a brief background of prior literature. Understanding the key design guidelines and failure mechanisms from past tests is critical to developing an approach that will minimize future failures. Additional specific testing enables low-risk insertion of these advanced electronic packages.

  5. 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

  6. Cybernetics of Brief Family Therapy.

    ERIC Educational Resources Information Center

    Keeney, Bradford P.; Ross, Jeffrey M.

    1983-01-01

    Presents a cybernetic view of brief family therapy. Includes a historical discussion of the key ideas underlying brief family therapy, a cybernetic model of therapeutic change, and a clinical case for exemplification. (Author/JAC)

  7. Packaging - Materials review

    SciTech Connect

    Herrmann, Matthias

    2014-06-16

    Nowadays, a large number of different electrochemical energy storage systems are known. In the last two decades the development was strongly driven by a continuously growing market of portable electronic devices (e.g. cellular phones, lap top computers, camcorders, cameras, tools). Current intensive efforts are under way to develop systems for automotive industry within the framework of electrically propelled mobility (e.g. hybrid electric vehicles, plug-in hybrid electric vehicles, full electric vehicles) and also for the energy storage market (e.g. electrical grid stability, renewable energies). Besides the different systems (cell chemistries), electrochemical cells and batteries were developed and are offered in many shapes, sizes and designs, in order to meet performance and design requirements of the widespread applications. Proper packaging is thereby one important technological step for designing optimum, reliable and safe batteries for operation. In this contribution, current packaging approaches of cells and batteries together with the corresponding materials are discussed. The focus is laid on rechargeable systems for industrial applications (i.e. alkaline systems, lithium-ion, lead-acid). In principle, four different cell types (shapes) can be identified - button, cylindrical, prismatic and pouch. Cell size can be either in accordance with international (e.g. International Electrotechnical Commission, IEC) or other standards or can meet application-specific dimensions. Since cell housing or container, terminals and, if necessary, safety installations as inactive (non-reactive) materials reduce energy density of the battery, the development of low-weight packages is a challenging task. In addition to that, other requirements have to be fulfilled: mechanical stability and durability, sealing (e.g. high permeation barrier against humidity for lithium-ion technology), high packing efficiency, possible installation of safety devices (current interrupt device

  8. Packaging - Materials review

    NASA Astrophysics Data System (ADS)

    Herrmann, Matthias

    2014-06-01

    Nowadays, a large number of different electrochemical energy storage systems are known. In the last two decades the development was strongly driven by a continuously growing market of portable electronic devices (e.g. cellular phones, lap top computers, camcorders, cameras, tools). Current intensive efforts are under way to develop systems for automotive industry within the framework of electrically propelled mobility (e.g. hybrid electric vehicles, plug-in hybrid electric vehicles, full electric vehicles) and also for the energy storage market (e.g. electrical grid stability, renewable energies). Besides the different systems (cell chemistries), electrochemical cells and batteries were developed and are offered in many shapes, sizes and designs, in order to meet performance and design requirements of the widespread applications. Proper packaging is thereby one important technological step for designing optimum, reliable and safe batteries for operation. In this contribution, current packaging approaches of cells and batteries together with the corresponding materials are discussed. The focus is laid on rechargeable systems for industrial applications (i.e. alkaline systems, lithium-ion, lead-acid). In principle, four different cell types (shapes) can be identified - button, cylindrical, prismatic and pouch. Cell size can be either in accordance with international (e.g. International Electrotechnical Commission, IEC) or other standards or can meet application-specific dimensions. Since cell housing or container, terminals and, if necessary, safety installations as inactive (non-reactive) materials reduce energy density of the battery, the development of low-weight packages is a challenging task. In addition to that, other requirements have to be fulfilled: mechanical stability and durability, sealing (e.g. high permeation barrier against humidity for lithium-ion technology), high packing efficiency, possible installation of safety devices (current interrupt device

  9. Simulating water, solute, and heat transport in the subsurface with the VS2DI software package

    USGS Publications Warehouse

    Healy, R.W.

    2008-01-01

    The software package VS2DI was developed by the U.S. Geological Survey for simulating water, solute, and heat transport in variably saturated porous media. The package consists of a graphical preprocessor to facilitate construction of a simulation, a postprocessor for visualizing simulation results, and two numerical models that solve for flow and solute transport (VS2DT) and flow and heat transport (VS2DH). The finite-difference method is used to solve the Richards equation for flow and the advection-dispersion equation for solute or heat transport. This study presents a brief description of the VS2DI package, an overview of the various types of problems that have been addressed with the package, and an analysis of the advantages and limitations of the package. A review of other models and modeling approaches for studying water, solute, and heat transport also is provided. ?? Soil Science Society of America. All rights reserved.

  10. Components of Adenovirus Genome Packaging

    PubMed Central

    Ahi, Yadvinder S.; Mittal, Suresh K.

    2016-01-01

    Adenoviruses (AdVs) are icosahedral viruses with double-stranded DNA (dsDNA) genomes. Genome packaging in AdV is thought to be similar to that seen in dsDNA containing icosahedral bacteriophages and herpesviruses. Specific recognition of the AdV genome is mediated by a packaging domain located close to the left end of the viral genome and is mediated by the viral packaging machinery. Our understanding of the role of various components of the viral packaging machinery in AdV genome packaging has greatly advanced in recent years. Characterization of empty capsids assembled in the absence of one or more components involved in packaging, identification of the unique vertex, and demonstration of the role of IVa2, the putative packaging ATPase, in genome packaging have provided compelling evidence that AdVs follow a sequential assembly pathway. This review provides a detailed discussion on the functions of the various viral and cellular factors involved in AdV genome packaging. We conclude by briefly discussing the roles of the empty capsids, assembly intermediates, scaffolding proteins, portal vertex and DNA encapsidating enzymes in AdV assembly and packaging. PMID:27721809

  11. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... discuss FDA's use of international comparability assessments as a mechanism to enhance the safety of... countries regarding the regulatory policies, practices, and programs they currently use to ensure the safety... discuss FDA's use of international comparability assessments as a mechanism to enhance the safety...

  12. OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

    PubMed Central

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  13. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  15. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  16. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates...

  17. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's... 21 Food and Drugs 3 2014-04-01 2014-04-01 false The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective....

  18. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Processing...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at...

  19. 77 FR 52036 - Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Records Related to Research Misconduct Proceedings AGENCY: Food and Drug Administration, HHS. ACTION... Related to Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020. Under the Department of... Misconduct, FDA has responsibilities for addressing research integrity and misconduct issues related to...

  20. 77 FR 70955 - FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 FDA Actions Related to Nicotine Replacement... Tobacco Dependence; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA)...

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

    PubMed

    Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra

    2015-11-01

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

  2. Aristos Optimization Package

    SciTech Connect

    Ridzal, Danis

    2007-03-01

    Aristos is a Trilinos package for nonlinear continuous optimization, based on full-space sequential quadratic programming (SQP) methods. Aristos is specifically designed for the solution of large-scale constrained optimization problems in which the linearized constraint equations require iterative (i.e. inexact) linear solver techniques. Aristos' unique feature is an efficient handling of inexactness in linear system solves. Aristos currently supports the solution of equality-constrained convex and nonconvex optimization problems. It has been used successfully in the area of PDE-constrained optimization, for the solution of nonlinear optimal control, optimal design, and inverse problems.

  3. Safety Analysis Report for packaging (onsite) steel waste package

    SciTech Connect

    BOEHNKE, W.M.

    2000-07-13

    The steel waste package is used primarily for the shipment of remote-handled radioactive waste from the 324 Building to the 200 Area for interim storage. The steel waste package is authorized for shipment of transuranic isotopes. The maximum allowable radioactive material that is authorized is 500,000 Ci. This exceeds the highway route controlled quantity (3,000 A{sub 2}s) and is a type B packaging.

  4. Brief therapy: focused solution development.

    PubMed

    De Shazer, S; Berg, I K; Lipchik, E; Nunnally, E; Molnar, A; Gingerich, W; Weiner-Davis, M

    1986-06-01

    This article describes the form of brief therapy developed at the Brief Family Therapy Center. We have chosen a title similar to Weakland, Fisch, Watzlawick, and Bodin's classic paper, "Brief Therapy: Focused Problem Resolution" (20) to emphasize our view that there is a conceptual relationship and a developmental connection between the points of view expressed in the two papers.

  5. Generic School Grounds Design Brief.

    ERIC Educational Resources Information Center

    Dorset County Council, Dorchester (England).

    This document was produced to provide architects, planners, and builders with an educational design brief for Dorset, England school grounds. The County Education Planning and Development Department will use it as an educational and curriculum statement to complement their more detailed and specific building briefs. The brief uses many of the…

  6. Weaving New Meanings: Evaluating Children's Written Responses to a Story Telling Resource Package

    ERIC Educational Resources Information Center

    Brady, Josephine; Millard, Elaine

    2012-01-01

    This paper documents an evaluation of children's written responses to a story telling package used in an intervention project set up by the National Association for the Teaching of English as part of the larger "Inspire Rotherham" literacy campaign. The brief was to provide a group of primary teachers with innovative and inspirational approaches…

  7. CH Packaging Operations Manual

    SciTech Connect

    None, None

    2009-05-27

    This document provides the user with instructions for assembling a payload. All the steps in Subsections 1.2, Preparing 55-Gallon Drum Payload Assembly; 1.3, Preparing "Short" 85-Gallon Drum Payload Assembly (TRUPACT-II and HalfPACT); 1.4, Preparing "Tall" 85-Gallon Drum Payload Assembly (HalfPACT only); 1.5, Preparing 100-Gallon Drum Payload Assembly; 1.6, Preparing Shielded Container Payload Assembly; 1.7, Preparing SWB Payload Assembly; and 1.8, Preparing TDOP Payload Assembly, must be completed, but may be performed in any order as long as radiological control steps are not bypassed. Transport trailer operations, package loading and unloading from transport trailers, hoisting and rigging activities such as ACGLF operations, equipment checkout and shutdown, and component inspection activities must be performed, but may be performed in any order and in parallel with other activities as long as radiological control steps are not bypassed. Steps involving OCA/ICV lid removal/installation and payload removal/loading may be performed in parallel if there are multiple operators working on the same packaging. Steps involving removal/installation of OCV/ICV upper and lower main O-rings must be performed in sequence, except as noted.

  8. CH Packaging Operations Manual

    SciTech Connect

    None, None

    2008-09-11

    This document provides the user with instructions for assembling a payload. All the steps in Subsections 1.2, Preparing 55-Gallon Drum Payload Assembly; 1.3, Preparing "Short" 85-Gallon Drum Payload Assembly (TRUPACT-II and HalfPACT); 1.4, Preparing "Tall" 85-gallon Drum Payload Assembly (HalfPACT only); 1.5, Preparing 100-Gallon Drum Payload Assembly; 1.6, Preparing SWB Payload Assembly; and 1.7, Preparing TDOP Payload Assembly, must be completed, but may be performed in any order as long as radiological control steps are not bypassed. Transport trailer operations, package loading and unloading from transport trailers, hoisting and rigging activities such as ACGLF operations, equipment checkout and shutdown, and component inspection activities must be performed, but may be performed in any order and in parallel with other activities as long as radiological control steps are not bypassed. Steps involving OCA/ICV lid removal/installation and payload removal/loading may be performed in parallel if there are multiple operators working on the same packaging. Steps involving removal/installation of OCV/ICV upper and lower main O-rings must be performed in sequence.

  9. Japan's electronic packaging technologies

    NASA Technical Reports Server (NTRS)

    Tummala, Rao R.; Pecht, Michael

    1995-01-01

    The JTEC panel found Japan to have significant leadership over the United States in the strategic area of electronic packaging. Many technologies and products once considered the 'heart and soul' of U.S. industry have been lost over the past decades to Japan and other Asian countries. The loss of consumer electronics technologies and products is the most notable of these losses, because electronics is the United States' largest employment sector and is critical for growth businesses in consumer products, computers, automobiles, aerospace, and telecommunications. In the past there was a distinction between consumer and industrial product technologies. While Japan concentrated on the consumer market, the United States dominated the industrial sector. No such distinction is anticipated in the future; the consumer-oriented technologies Japan has dominated are expected to characterize both domains. The future of U.S. competitiveness will, therefore, depend on the ability of the United States to rebuild its technological capabilities in the area of portable electronic packaging.

  10. Japan's electronic packaging technologies

    NASA Astrophysics Data System (ADS)

    Tummala, Rao R.; Pecht, Michael

    1995-02-01

    The JTEC panel found Japan to have significant leadership over the United States in the strategic area of electronic packaging. Many technologies and products once considered the 'heart and soul' of U.S. industry have been lost over the past decades to Japan and other Asian countries. The loss of consumer electronics technologies and products is the most notable of these losses, because electronics is the United States' largest employment sector and is critical for growth businesses in consumer products, computers, automobiles, aerospace, and telecommunications. In the past there was a distinction between consumer and industrial product technologies. While Japan concentrated on the consumer market, the United States dominated the industrial sector. No such distinction is anticipated in the future; the consumer-oriented technologies Japan has dominated are expected to characterize both domains. The future of U.S. competitiveness will, therefore, depend on the ability of the United States to rebuild its technological capabilities in the area of portable electronic packaging.

  11. Signal processor packaging design

    NASA Astrophysics Data System (ADS)

    McCarley, Paul L.; Phipps, Mickie A.

    1993-10-01

    The Signal Processor Packaging Design (SPPD) program was a technology development effort to demonstrate that a miniaturized, high throughput programmable processor could be fabricated to meet the stringent environment imposed by high speed kinetic energy guided interceptor and missile applications. This successful program culminated with the delivery of two very small processors, each about the size of a large pin grid array package. Rockwell International's Tactical Systems Division in Anaheim, California developed one of the processors, and the other was developed by Texas Instruments' (TI) Defense Systems and Electronics Group (DSEG) of Dallas, Texas. The SPPD program was sponsored by the Guided Interceptor Technology Branch of the Air Force Wright Laboratory's Armament Directorate (WL/MNSI) at Eglin AFB, Florida and funded by SDIO's Interceptor Technology Directorate (SDIO/TNC). These prototype processors were subjected to rigorous tests of their image processing capabilities, and both successfully demonstrated the ability to process 128 X 128 infrared images at a frame rate of over 100 Hz.

  12. Space station power semiconductor package

    NASA Technical Reports Server (NTRS)

    Balodis, Vilnis; Berman, Albert; Devance, Darrell; Ludlow, Gerry; Wagner, Lee

    1987-01-01

    A package of high-power switching semiconductors for the space station have been designed and fabricated. The package includes a high-voltage (600 volts) high current (50 amps) NPN Fast Switching Power Transistor and a high-voltage (1200 volts), high-current (50 amps) Fast Recovery Diode. The package features an isolated collector for the transistors and an isolated anode for the diode. Beryllia is used as the isolation material resulting in a thermal resistance for both devices of .2 degrees per watt. Additional features include a hermetical seal for long life -- greater than 10 years in a space environment. Also, the package design resulted in a low electrical energy loss with the reduction of eddy currents, stray inductances, circuit inductance, and capacitance. The required package design and device parameters have been achieved. Test results for the transistor and diode utilizing the space station package is given.

  13. Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

    NASA Technical Reports Server (NTRS)

    Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

    2007-01-01

    Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training

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

    PubMed Central

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

    2016-01-01

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

  15. IN-PACKAGE CHEMISTRY ABSTRACTION

    SciTech Connect

    E. Thomas

    2005-07-14

    This report was developed in accordance with the requirements in ''Technical Work Plan for Postclosure Waste Form Modeling'' (BSC 2005 [DIRS 173246]). The purpose of the in-package chemistry model is to predict the bulk chemistry inside of a breached waste package and to provide simplified expressions of that chemistry as a function of time after breach to Total Systems Performance Assessment for the License Application (TSPA-LA). The scope of this report is to describe the development and validation of the in-package chemistry model. The in-package model is a combination of two models, a batch reactor model, which uses the EQ3/6 geochemistry-modeling tool, and a surface complexation model, which is applied to the results of the batch reactor model. The batch reactor model considers chemical interactions of water with the waste package materials, and the waste form for commercial spent nuclear fuel (CSNF) waste packages and codisposed (CDSP) waste packages containing high-level waste glass (HLWG) and DOE spent fuel. The surface complexation model includes the impact of fluid-surface interactions (i.e., surface complexation) on the resulting fluid composition. The model examines two types of water influx: (1) the condensation of water vapor diffusing into the waste package, and (2) seepage water entering the waste package as a liquid from the drift. (1) Vapor-Influx Case: The condensation of vapor onto the waste package internals is simulated as pure H{sub 2}O and enters at a rate determined by the water vapor pressure for representative temperature and relative humidity conditions. (2) Liquid-Influx Case: The water entering a waste package from the drift is simulated as typical groundwater and enters at a rate determined by the amount of seepage available to flow through openings in a breached waste package.

  16. Naval Waste Package Design Report

    SciTech Connect

    M.M. Lewis

    2004-03-15

    A design methodology for the waste packages and ancillary components, viz., the emplacement pallets and drip shields, has been developed to provide designs that satisfy the safety and operational requirements of the Yucca Mountain Project. This methodology is described in the ''Waste Package Design Methodology Report'' Mecham 2004 [DIRS 166168]. To demonstrate the practicability of this design methodology, four waste package design configurations have been selected to illustrate the application of the methodology. These four design configurations are the 21-pressurized water reactor (PWR) Absorber Plate waste package, the 44-boiling water reactor (BWR) waste package, the 5-defense high-level waste (DHLW)/United States (U.S.) Department of Energy (DOE) spent nuclear fuel (SNF) Co-disposal Short waste package, and the Naval Canistered SNF Long waste package. Also included in this demonstration is the emplacement pallet and continuous drip shield. The purpose of this report is to document how that design methodology has been applied to the waste package design configurations intended to accommodate naval canistered SNF. This demonstrates that the design methodology can be applied successfully to this waste package design configuration and support the License Application for construction of the repository.

  17. Hazardous materials package performance regulations

    SciTech Connect

    Russell, N. A.; Glass, R. E.; McClure, J. D.; Finley, N. C.

    1991-01-01

    This paper discusses a hazardous materials Hazmat Packaging Performance Evaluation (HPPE) project being conducted at Sandia National Laboratories for the US Department of Transportation Research Special Programs Administration (DOT-RSPA) to look at the subset of bulk packagings that are larger than 2000 gallons. The objectives of this project are to evaluate current hazmat specification packagings and develop supporting documentation for determining performance requirements for packagings in excess of 2000 gallons that transport hazardous materials that have been classified as extremely toxic by inhalation (METBI).

  18. About the ZOOM minimization package

    SciTech Connect

    Fischler, M.; Sachs, D.; /Fermilab

    2004-11-01

    A new object-oriented Minimization package is available for distribution in the same manner as CLHEP. This package, designed for use in HEP applications, has all the capabilities of Minuit, but is a re-write from scratch, adhering to modern C++ design principles. A primary goal of this package is extensibility in several directions, so that its capabilities can be kept fresh with as little maintenance effort as possible. This package is distinguished by the priority that was assigned to C++ design issues, and the focus on producing an extensible system that will resist becoming obsolete.

  19. Galileo Science Writers' Briefing

    NASA Astrophysics Data System (ADS)

    1989-08-01

    This NASA Kennedy video production presents Part 2 of a press conference held at JPL on August 8, 1989. The briefing in its entirety covers the Galileo Project's mission design from launch to completion in 1997 and is moderated by JPL Public Information Mgr. Robert Macmillan. Part 2 of the 3 part video series begins with Richard J. Spehalski's (Galileo Project Manager) description of the spacecraft and mission operations. E. Cherniack gives a slide presentation of a Galileo spacecraft model and some design features unique to the spacecraft. John Givens (Probe System Design Manager) then presents a brief overview of the mission and subsystems surrounding the Galileo Space Probe. Neal E. Ausman, Jr. (Mission Director) ends the video with a discussion of mission operations including slides of the Galileo launch scenario and a trajectory correction maneuver.

  20. Strategic forces briefing

    SciTech Connect

    Bing, G.; Chrzanowski, P.; May, M.; Nordyke, M.

    1989-04-06

    The Strategic Forces Briefing'' is our attempt, accomplished over the past several months, to outline and highlight the more significant strategic force issues that must be addressed in the near future. Some issues are recurrent: the need for an effective modernized Triad and a constant concern for force survivability. Some issues derive from arms control: the Strategic Arms Reduction Talks (SALT) are sufficiently advanced to set broad numerical limits on forces, but not so constraining as to preclude choices among weapon systems and deployment modes. Finally, a new administration faced with serious budgetary problems must strive for the most effective strategic forces limited dollars can buy and support. A review of strategic forces logically begins with consideration of the missions the forces are charged with. We begin the briefing with a short review of targeting policy and implementation within the constraints of available unclassified information. We then review each element of the Triad with sections on SLBMs, ICBMs, and Air-Breathing (bomber and cruise missile) systems. A short section at the end deals with the potential impact of strategic defense on offensive force planning. We consider ABM, ASAT, and air defense; but we do not attempt to address the technical issues of strategic defense per se. The final section gives a brief overview of the tritium supply problem. We conclude with a summary of recommendations that emerge from our review. The results of calculation on the effectiveness of various weapon systems as a function of cost that are presented in the briefing are by Paul Chrzanowski.

  1. NASA tech brief evaluations

    NASA Technical Reports Server (NTRS)

    Workman, Gary L.

    1994-01-01

    A major step in transferring technology is to disseminate information about new developments to the appropriate sector(s). A useful vehicle for transferring technology from the government sector to industry has been demonstrated with the use of periodical and journal announcements to highlight technological achievements which may meet the needs of industries other than the one who developed the innovation. To meet this end, NASA has very successfully pursued the goal of identifying technical innovations through the national circulation publication; NASA Tech Briefs. At one time the Technology Utilization Offices of the various centers coordinated the selection of appropriate technologies through a common channel. In recent years, each NASA field center has undertaken the task of evaluating submittals for Tech Brief publication independently of the others. The University of Alabama in Huntsville was selected to assist MSFC in evaluating technology developed under the various programs managed by the NASA center for publication in the NASA Tech Briefs journal. The primary motivation for the NASA Tech Briefs publication is to bring to the attention of industry the various NASA technologies which, in general, have been developed for a specific aerospace requirement, but has application in other areas. Since there are a number of applications outside of NASA that can benefit from innovative concepts developed within the MSPC programs, the ability to transfer technology to other sectors is very high. In most cases, the innovator(s) are not always knowledgeable about other industries which might potentially benefit from their innovation. The evaluation process can therefore contribute to the list of potential users through a knowledgeable evaluator.

  2. Package Up Your Troubles--An Introduction to Package Libraries

    ERIC Educational Resources Information Center

    Frank, Colin

    1978-01-01

    Discusses a "package deal" library--a prefabricated building including interior furnishing--in terms of costs, fitness for purpose, and interior design, i.e., shelving, flooring, heating, lighting, and humidity. Advantages and disadvantages of the package library are also considered. (Author/MBR)

  3. The Packaging Handbook -- A guide to package design

    SciTech Connect

    Shappert, L.B.

    1995-12-31

    The Packaging Handbook is a compilation of 14 technical chapters and five appendices that address the life cycle of a packaging which is intended to transport radioactive material by any transport mode in normal commerce. Although many topics are discussed in depth, this document focuses on the design aspects of a packaging. The Handbook, which is being prepared under the direction of the US Department of Energy, is intended to provide a wealth of technical guidance that will give designers a better understanding of the regulatory approval process, preferences of regulators in specific aspects of packaging design, and the types of analyses that should be seriously considered when developing the packaging design. Even though the Handbook is concerned with all packagings, most of the emphasis is placed on large packagings that are capable of transporting large radioactive sources that are also fissile (e.g., spent fuel). These are the types of packagings that must address the widest range of technical topics in order to meet domestic and international regulations. Most of the chapters in the Handbook have been drafted and submitted to the Oak Ridge National Laboratory for editing; the majority of these have been edited. This report summarizes the contents.

  4. Anhydrous Ammonia Training Module. Trainer's Package. Participant's Package.

    ERIC Educational Resources Information Center

    Beaudin, Bart; And Others

    This document contains a trainer's and a participant's package for teaching employees on site safe handling procedures for working with anhydrous ammonia, especially on farms. The trainer's package includes the following: a description of the module; a competency; objectives; suggested instructional aids; a training outline (or lesson plan) for…

  5. Tritium waste package

    DOEpatents

    Rossmassler, Rich; Ciebiera, Lloyd; Tulipano, Francis J.; Vinson, Sylvester; Walters, R. Thomas

    1995-01-01

    A containment and waste package system for processing and shipping tritium xide waste received from a process gas includes an outer drum and an inner drum containing a disposable molecular sieve bed (DMSB) seated within outer drum. The DMSB includes an inlet diffuser assembly, an outlet diffuser assembly, and a hydrogen catalytic recombiner. The DMSB absorbs tritium oxide from the process gas and converts it to a solid form so that the tritium is contained during shipment to a disposal site. The DMSB is filled with type 4A molecular sieve pellets capable of adsorbing up to 1000 curies of tritium. The recombiner contains a sufficient amount of catalyst to cause any hydrogen add oxygen present in the process gas to recombine to form water vapor, which is then adsorbed onto the DMSB.

  6. Tritium waste package

    DOEpatents

    Rossmassler, R.; Ciebiera, L.; Tulipano, F.J.; Vinson, S.; Walters, R.T.

    1995-11-07

    A containment and waste package system for processing and shipping tritium oxide waste received from a process gas includes an outer drum and an inner drum containing a disposable molecular sieve bed (DMSB) seated within the outer drum. The DMSB includes an inlet diffuser assembly, an outlet diffuser assembly, and a hydrogen catalytic recombiner. The DMSB absorbs tritium oxide from the process gas and converts it to a solid form so that the tritium is contained during shipment to a disposal site. The DMSB is filled with type 4A molecular sieve pellets capable of adsorbing up to 1000 curies of tritium. The recombiner contains a sufficient amount of catalyst to cause any hydrogen and oxygen present in the process gas to recombine to form water vapor, which is then adsorbed onto the DMSB. 1 fig.

  7. The LISA Technology Package

    NASA Technical Reports Server (NTRS)

    Livas, Jeff

    2009-01-01

    The LISA Technology Package (LTP) is the payload of the European Space Agency's LISA Pathfinder mission. LISA Pathfinder was instigated to test, in a flight environment, the critical technologies required by LISA; namely, the inertial sensing subsystem and associated control laws and micro-Newton thrusters required to place a macroscopic test mass in pure free-fall. The UP is in the late stages of development -- all subsystems are currently either in the final stages of manufacture or in test. Available flight units are being integrated into the real-time testbeds for system verification tests. This poster will describe the UP and its subsystems, give the current status of the hardware and test campaign, and outline the future milestones leading to the UP delivery.

  8. Balloon gondola diagnostics package

    NASA Astrophysics Data System (ADS)

    Cantor, K. M.

    1986-10-01

    In order to define a new gondola structural specification and to quantify the balloon termination environment, NASA developed a balloon gondola diagnostics package (GDP). This addition to the balloon flight train is comprised of a large array of electronic sensors employed to define the forces and accelerations imposed on a gondola during the termination event. These sensors include the following: a load cell, a three-axis accelerometer, two three-axis rate gyros, two magnetometers, and a two axis inclinometer. A transceiver couple allows the data to be telemetered across any in-line rotator to the gondola-mounted memory system. The GDP is commanded 'ON' just prior to parachute deployment in order to record the entire event.

  9. Electro-Microfluidic Packaging

    SciTech Connect

    BENAVIDES, GILBERT L.; GALAMBOS, PAUL C.

    2002-06-01

    Electro-microfluidics is experiencing explosive growth in new product developments. There are many commercial applications for electro-microfluidic devices such as chemical sensors, biological sensors, and drop ejectors for both printing and chemical analysis. The number of silicon surface micromachined electro-microfluidic products is likely to increase. Manufacturing efficiency and integration of microfluidics with electronics will become important. Surface micromachined microfluidic devices are manufactured with the same tools as IC's (integrated circuits) and their fabrication can be incorporated into the IC fabrication process. In order to realize applications for devices must be developed. An Electro-Microfluidic Dual In-line Package (EMDIP{trademark}) was developed surface micromachined electro-microfluidic devices, a practical method for getting fluid into these to be a standard solution that allows for both the electrical and the fluidic connections needed to operate a great variety of electro-microfluidic devices. The EMDIP{trademark} includes a fan-out manifold that, on one side, mates directly with the 200 micron diameter Bosch etched holes found on the device, and, on the other side, mates to lager 1 mm diameter holes. To minimize cost the EMDIP{trademark} can be injection molded in a great variety of thermoplastics which also serve to optimize fluid compatibility. The EMDIP{trademark} plugs directly into a fluidic printed wiring board using a standard dual in-line package pattern for the electrical connections and having a grid of multiple 1 mm diameter fluidic connections to mate to the underside of the EMDIP{trademark}.

  10. Chip packaging technique

    NASA Technical Reports Server (NTRS)

    Jayaraj, Kumaraswamy (Inventor); Noll, Thomas E. (Inventor); Lockwood, Harry F. (Inventor)

    2001-01-01

    A hermetically sealed package for at least one semiconductor chip is provided which is formed of a substrate having electrical interconnects thereon to which the semiconductor chips are selectively bonded, and a lid which preferably functions as a heat sink, with a hermetic seal being formed around the chips between the substrate and the heat sink. The substrate is either formed of or includes a layer of a thermoplastic material having low moisture permeability which material is preferably a liquid crystal polymer (LCP) and is a multiaxially oriented LCP material for preferred embodiments. Where the lid is a heat sink, the heat sink is formed of a material having high thermal conductivity and preferably a coefficient of thermal expansion which substantially matches that of the chip. A hermetic bond is formed between the side of each chip opposite that connected to the substrate and the heat sink. The thermal bond between the substrate and the lid/heat sink may be a pinched seal or may be provided, for example by an LCP frame which is hermetically bonded or sealed on one side to the substrate and on the other side to the lid/heat sink. The chips may operate in the RF or microwave bands with suitable interconnects on the substrate and the chips may also include optical components with optical fibers being sealed into the substrate and aligned with corresponding optical components to transmit light in at least one direction. A plurality of packages may be physically and electrically connected together in a stack to form a 3D array.

  11. A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

    PubMed

    Carpenter, Daniel

    2005-01-01

    I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augmentation is an achievable, incremental reform that would subsidize information that is now undersupplied in the U.S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system.

  12. FDA, CE mark or something else?-Thinking fast and slow.

    PubMed

    Mishra, Sundeep

    There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive.

  13. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    PubMed

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.

  14. FDA regulation of dietary supplements and requirements regarding adverse event reporting.

    PubMed

    Frankos, V H; Street, D A; O'Neill, R K

    2010-02-01

    In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.

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

    PubMed Central

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

    2015-01-01

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

  16. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.

    PubMed

    2017-01-01

    Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients

  17. Inspection of computer-supported toxicological data submitted to the FDA.

    PubMed

    Taylor, D W

    1984-01-01

    The FDA's Good Laboratory Practice Regulations (GLP) have been formally amended (once) and two formed 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 have been a problem--the definition of "raw data," the documentation process for the maintenance of "raw data," standard operating procedures, and study protocols. The increasing use of computers for supporting toxicology/pathology studies raises several questions concerning the impact of the GLPs on computerized data collection/reporting. This paper will address the above questions and discuss systems, procedures, interpretations, and some unresolved problems, as well as provide practical approaches for internal review of computer-supported nonclinical laboratory studies.

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

    PubMed

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

    2005-12-01

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

  19. Programme on the recyclability of food-packaging materials with respect to food safety considerations: polyethylene terephthalate (PET), paper and board, and plastics covered by functional barriers.

    PubMed

    Franz, R

    2002-01-01

    Stimulated by new ecology-driven European and national regulations, news routes of recycling waste appear on the market. Since food packages represent a large percentage of the plastics consumption and since they have a short lifetime, an important approach consists in making new packages from post-consumer used packages. On the other hand, food-packaging regulations in Europe require that packaging materials must be safe. Therefore, potential mass transfer (migration) of harmful recycling-related substances to the food must be excluded and test methods to ensure the safety-in-use of recycled materials for food packaging are needled. As a consequence of this situation, a European research project FAIR-CT98-4318, with the acronym 'Recyclability', was initiated. The project consists of three sections each focusing on a different class of recycled materials: polyethylene terephthalate (PET), paper and board, and plastics covered by functional barriers. The project consortium consists of 28 project members from 11 EU countries. In addition, the project is during its lifetime in discussion with the US Food and Drug Administrations (FDA) to consider also US FDA regulatory viewpoints and to aim, as a consequence, to harmonizable conclusions and recommendations. The paper introduces the project and presents an overview of the project work progress.

  20. The Brief Symptom Inventory: A Validity-Reliability Study of a Sample from Azerbaijan

    ERIC Educational Resources Information Center

    Kerimova, Melek; Osmanli, Nermin

    2016-01-01

    The aim of this research was to adapt "Brief Symptom Inventory" developed by Derogatis (1983) into Azerbaijani language. Data were collected from 309 college students to determine psychometric properties of inventory. Samples in the study have been selected separately. The package programs of SPSS 18.0 and Lisrel 8.80 were used for the…

  1. Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting

    PubMed Central

    Mandl, Kenneth D; McNabb, Marion; Marks, Norman; Weitzman, Elissa R; Kelemen, Skyler; Eggleston, Emma M; Quinn, Maryanne

    2014-01-01

    Background and objective Malfunctions or poor usability of devices measuring glucose or delivering insulin are reportable to the FDA. Manufacturers submit 99.9% of these reports. We test online social networks as a complementary source to traditional FDA reporting of device-related adverse events. Methods Participatory surveillance of members of a non-profit online social network, TuDiabetes.org, from October 2011 to September 2012. Subjects were volunteers from a group within TuDiabetes, actively engaged online in participatory surveillance. They used the free TuAnalyze app, a privacy-preserving method to report detailed clinical information, available through the network. Network members were polled about finger-stick blood glucose monitors, continuous glucose monitors, and insulin delivery devices, including insulin pumps and insulin pens. Results Of 549 participants, 75 reported device-related adverse events, nearly half (48.0%) requiring intervention from another person to manage the event. Only three (4.0%) of these were reported by participants to the FDA. All TuAnalyze reports contained outcome information compared with 22% of reports to the FDA. Hypoglycemia and hyperglycemia were experienced by 48.0% and 49.3% of participants, respectively. Discussion Members of an online community readily engaged in participatory surveillance. While polling distributed online populations does not yield generalizable, denominator-based rates, this approach can characterize risk within online communities using a bidirectional communication channel that enables reach-back and intervention. Conclusions Engagement of distributed communities in social networks is a viable complementary approach to traditional public health surveillance for adverse events related to medical devices. PMID:24355131

  2. FDA Approves Test to Aid Post-PSA Biopsy Decisions | Division of Cancer Prevention

    Cancer.gov

    The Food and Drug Administration (FDA) has approved a test to help men with elevated prostate-specific antigen (PSA) test scores decide whether to have a biopsy to test for prostate cancer. The Access Hybritech p2PSA test is approved for use in men aged 50 or older who have a PSA test score between 4 and 10 ng/ml but who show no signs of cancer during a digital rectal exam. |

  3. The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.

    PubMed

    Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

    2016-07-01

    The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.

  4. FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys | Division of Cancer Prevention

    Cancer.gov

    The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |

  5. Rationale, Procedures, and Response Rates for the 2015 Administration of NCI's Health Information National Trends Survey: HINTS-FDA 2015.

    PubMed

    Blake, Kelly D; Portnoy, David B; Kaufman, Annette R; Lin, Chung-Tung Jordan; Lo, Serena C; Backlund, Eric; Cantor, David; Hicks, Lloyd; Lin, Amy; Caporaso, Andrew; Davis, Terisa; Moser, Richard P; Hesse, Bradford W

    2016-12-01

    The National Cancer Institute (NCI) developed the Health Information National Trends Survey (HINTS) to monitor population trends in cancer communication practices, information preferences, health risk behaviors, attitudes, and cancer knowledge. The U.S. Food and Drug Administration (FDA) recognized HINTS as a unique data resource for informing its health communication endeavors and partnered with NCI to field HINTS-FDA 2015. HINTS-FDA 2015 was a self-administered paper instrument sent by mail May 29 to September 8, 2015, using a random probability-based sample of U.S. postal addresses stratified by county-level smoking rates, with an oversampling of high and medium-high smoking strata to increase the yield of current smokers responding to the survey. The response rate for HINTS-FDA 2015 was 33% (N = 3,738). The yield of current smokers (n = 495) was lower than expected, but the sampling strategy achieved the goal of obtaining more former smokers (n = 1,132). Public-use HINTS-FDA 2015 data and supporting documentation have been available for download and secondary data analyses since June 2016 at http://hints.cancer.gov . NCI and FDA encourage the use of HINTS-FDA for health communication research and practice related to tobacco-related communications, public knowledge, and behaviors as well as beliefs and actions related to medical products and dietary supplements.

  6. The impact of FDA guidance on pharmacogenomic data submissions on drug development.

    PubMed

    Little, Stephen

    2005-08-01

    After a long wait, the US Food and Drug Administration (FDA) finally released the much anticipated 'Guidance on Pharmacogenomic Data Submissions on Drug Development' in March 2005, but what impact will this have on the drug industry as a whole? It is becoming increasingly apparent that the field of pharmacogenomics can add value to both clinical trial design and the drug development process, but uptake by the pharmaceutical industry has so far been variable between companies. The opinion of the FDA is that the use of pharmacogenomics in drug development is a 'good thing' and one that it wishes to promote, hence, this new guidance is designed to assist drug companies to adopt pharmacogenomic technology in clinical development, and covers both targeted and exploratory aspects. While targeted pharmacogenomics must be included as part of any regulatory submission, exploratory approaches may be submitted voluntarily with assurances from the FDA that any such submissions will not be used to make regulatory decisions. With this regulatory framework now in place it is only a matter of time before it is known how the industry reacts and the impact it will have on drug development.

  7. Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop.

    PubMed

    Chang, Cindy M; Edwards, Selvin H; Arab, Aarthi; Del Valle-Pinero, Arseima Y; Yang, Ling; Hatsukami, Dorothy K

    2017-03-01

    Since 2009, the FDA Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified-risk tobacco products and identifying and evaluating potential product standards. On August 3-4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: (i) approaches to evaluating and selecting biomarkers; (ii) biomarkers of exposure and relationship to disease risk; (iii) currently used biomarkers of exposure and biomarkers in development; and (iv) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems. This article synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation. Cancer Epidemiol Biomarkers Prev; 26(3); 291-302. ©2016 AACR.

  8. Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor.

    PubMed

    Arns, Martijn; Loo, Sandra K; Sterman, M Barry; Heinrich, Hartmut; Kuntsi, Jonna; Asherson, Philip; Banaschewski, Tobias; Brandeis, Daniel

    2016-05-01

    Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD Assessment Aid (NEBA) Health test. The NEBA test relies upon an EEG-based measure, called the theta to beta ratio (TBR). Although this measure has yielded large differences between ADHD and non-ADHD groups in studies prior to 2009, recent studies and a meta-analysis could not replicate these findings. In this article, we have used the NEBA device as an exemplar for a discussion that distinguishes between FDA de novo marketing approval for a device and any claims that that device is empirically supported, scientifically validated with replicated findings. It is understood that the aims of each differ; however, for many, including the lay public as well as some mental health professionals, these terms may be confused and treated as though they are synonymous. With regard to the TBR measure, there is no reliable association or replication for its clinical usage in the ADHD diagnostic process. The recommendation for potential consumers of the NEBA Health test (as well as perhaps for other existing FDA-approved diagnostic tests) is caveat emptor (let the buyer beware!).

  9. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

    PubMed

    Rosania, Larry

    2010-01-01

    Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

  10. Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies.

    PubMed

    Eaglstein, William H; Kirsner, Robert S; Robson, Martin C

    2012-01-01

    The rising costs of caring for chronic cutaneous ulcers (CCUs) and recent appreciation of the mortality of CCUs have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCUs have been approved by the Food and Drug Administration (FDA) in over a decade, in part due to an inability to reach the FDA accepted end point of "complete wound closure." The frequent failure to reach the complete closure end point brings forward the question of the relevance of other healing end points such as improved quality of life, or partial healing. Because CCUs carry a prognosis and mortality rate worse than many cancers, it is reasonable to compare the FDA trial end points for cancer drug approval with those for CCUs. And the difference is quite striking. While there is only one end point for CCUs, there are five surrogate and three direct end points for cancers. In contrast to cancer, surrogate end points and partial healing are not acceptable for therapies aimed at CCUs. For example, making tumors smaller is an acceptable end point, but making CCUs smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCUs. As CCUs carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCUs is highly warranted.

  11. Solar water heater design package

    NASA Technical Reports Server (NTRS)

    1981-01-01

    Package describes commercial domestic-hot-water heater with roof or rack mounted solar collectors. System is adjustable to pre-existing gas or electric hot-water house units. Design package includes drawings, description of automatic control logic, evaluation measurements, possible design variations, list of materials and installation tools, and trouble-shooting guide and manual.

  12. Individualized Learning Package about Etching.

    ERIC Educational Resources Information Center

    Sauer, Michael J.

    An individualized learning package provides step-by-step instruction in the fundamentals of the etching process. Thirteen specific behavioral objectives are listed. A pretest, consisting of matching 15 etching terms with their definitions, is provided along with an answer key. The remainder of the learning package teaches the 13 steps of the…

  13. The Macro - TIPS Course Package.

    ERIC Educational Resources Information Center

    Heriot-Watt Univ., Edinburgh (Scotland). Esmee Fairbairn Economics Research Centre.

    The TIPS (Teaching Information Processing System) Course Package was designed to be used with the Macro-Games Course Package (SO 011 930) in order to train college students to apply the tools of economic analysis to current problems. TIPS is used to provide feedback and individualized assignments to students, as well as information about the…

  14. Chemical Energy: A Learning Package.

    ERIC Educational Resources Information Center

    Cohen, Ita; Ben-Zvi, Ruth

    1982-01-01

    A comprehensive teaching/learning chemical energy package was developed to overcome conceptual/experimental difficulties and time required for calculation of enthalpy changes. The package consists of five types of activities occuring in repeated cycles: group activities, laboratory experiments, inquiry questionnaires, teacher-led class…

  15. Microelectronics/electronic packaging potential

    NASA Technical Reports Server (NTRS)

    Sandeau, R. F.

    1977-01-01

    The trend toward smaller and lighter electronic packages was examined. It is suggested that electronic packaging engineers and microelectronic designers closely associate and give full attention to optimization of both disciplines on all product lines. Extensive research and development work underway to explore innovative ideas and make new inroads into the technology base, is expected to satisfy the demands of the 1980's.

  16. Oral Hygiene. Learning Activity Package.

    ERIC Educational Resources Information Center

    Hime, Kirsten

    This learning activity package on oral hygiene is one of a series of 12 titles developed for use in health occupations education programs. Materials in the package include objectives, a list of materials needed, a list of definitions, information sheets, reviews (self evaluations) of portions of the content, and answers to reviews. These topics…

  17. 49 CFR 173.63 - Packaging exceptions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Packaging exceptions. 173.63 Section 173.63... SHIPMENTS AND PACKAGINGS Definitions, Classification and Packaging for Class 1 § 173.63 Packaging exceptions... which are used to project fastening devices. (2) Packaging for cartridges, small arms, and...

  18. 49 CFR 173.411 - Industrial packagings.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... record retention applicable to Industrial Packaging Type 1 (IP-1), Industrial Packaging Type 2 (IP-2), and Industrial Packaging Type 3 (IP-3). (b) Industrial packaging certification and tests. (1) Each IP... specified in § 173.412(a) through (j). (4) Tank containers may be used as Industrial package Types 2 or...

  19. 19 CFR 191.13 - Packaging materials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 2 2010-04-01 2010-04-01 false Packaging materials. 191.13 Section 191.13 Customs... (CONTINUED) DRAWBACK General Provisions § 191.13 Packaging materials. (a) Imported packaging material... packaging material when used to package or repackage merchandise or articles exported or destroyed...

  20. 19 CFR 191.13 - Packaging materials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 19 Customs Duties 2 2012-04-01 2012-04-01 false Packaging materials. 191.13 Section 191.13 Customs... (CONTINUED) DRAWBACK General Provisions § 191.13 Packaging materials. (a) Imported packaging material... packaging material when used to package or repackage merchandise or articles exported or destroyed...

  1. Nanocomposite Sensors for Food Packaging

    NASA Astrophysics Data System (ADS)

    Avella, Maurizio; Errico, Maria Emanuela; Gentile, Gennaro; Volpe, Maria Grazia

    Nowadays nanotechnologies applied to the food packaging sector find always more applications due to a wide range of benefits that they can offer, such as improved barrier properties, improved mechanical performance, antimicrobial properties and so on. Recently many researches are addressed to the set up of new food packaging materials, in which polymer nanocomposites incorporate nanosensors, developing the so-called "smart" packaging. Some examples of nanocomposite sensors specifically realised for the food packaging industry are reported. The second part of this work deals with the preparation and characterisation of two new polymer-based nanocomposite systems that can be used as food packaging materials. Particularly the results concerning the following systems are illustrated: isotactic polypropylene (iPP) filled with CaCO3 nanoparticles and polycaprolactone (PCL) filled with SiO2 nanoparticles.

  2. Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

    PubMed

    Pelletier, David L

    2005-05-01

    The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

  3. VISITview -- A Package for Remote Collaborations and Training

    NASA Astrophysics Data System (ADS)

    Whittaker, T.

    2007-05-01

    The Virtual Institute for Satellite Integration Training (VISIT) program of the United States National Weather Service created the VISITview software package to facilitate its teletraining activities. The use of VISITview has grown beyond the original intent and is now used internationally for both training and collaborations using real-time data. For example, bi-monthly, live and realtime weather briefings are conducted between the US and over a dozen countries in the Caribbean and Central and South America using VISITview with web browsers. This presentation will give a brief historical perspective of VISIT and VISITview, an overview of creating and presenting material using VISITview in both a real-time, collaborative mode as well as synchronous distance training, and a description of the various topologies and modes that VISITview supports.

  4. Polymeric Packaging for Fully Implantable Wireless Neural Microsensors

    PubMed Central

    Aceros, Juan; Yin, Ming; Borton, David A.; Patterson, William R.; Bull, Christopher; Nurmikko, Arto V.

    2014-01-01

    We present polymeric packaging methods used for subcutaneous, fully implantable, broadband, and wireless neurosensors. A new tool for accelerated testing and characterization of biocompatible polymeric packaging materials and processes is described along with specialized test units to simulate our fully implantable neurosensor components, materials and fabrication processes. A brief description of the implantable systems is presented along with their current encapsulation methods based on polydimethylsiloxane (PDMS). Results from in-vivo testing of multiple implanted neurosensors in swine and non-human primates are presented. Finally, a novel augmenting polymer thin film material to complement the currently employed PDMS is introduced. This thin layer coating material is based on the Plasma Enhanced Chemical Vapor Deposition (PECVD) process of Hexamethyldisiloxane (HMDSO) and Oxygen (O2). PMID:23365999

  5. Polymeric packaging for fully implantable wireless neural microsensors.

    PubMed

    Aceros, Juan; Yin, Ming; Borton, David A; Patterson, William R; Bull, Christopher; Nurmikko, Arto V

    2012-01-01

    We present polymeric packaging methods used for subcutaneous, fully implantable, broadband, and wireless neurosensors. A new tool for accelerated testing and characterization of biocompatible polymeric packaging materials and processes is described along with specialized test units to simulate our fully implantable neurosensor components, materials and fabrication processes. A brief description of the implantable systems is presented along with their current encapsulation methods based on polydimethylsiloxane (PDMS). Results from in-vivo testing of multiple implanted neurosensors in swine and non-human primates are presented. Finally, a novel augmenting polymer thin film material to complement the currently employed PDMS is introduced. This thin layer coating material is based on the Plasma Enhanced Chemical Vapor Deposition (PECVD) process of Hexamethyldisiloxane (HMDSO) and Oxygen (O(2)).

  6. Banning front-of-package food labels: first Amendment constraints on public health policy.

    PubMed

    Lytton, Timothy D

    2011-06-01

    In recent months, the FDA has begun a crackdown on misleading nutrition and health claims on the front of food packages by issuing warning letters to manufacturers and promising to develop stricter regulatory standards. Leading nutrition policy experts Marion Nestle and David Ludwig have called for an even tougher approach: a ban on all nutrition and health claims on the front of food packages. Nestle and Ludwig argue that most of these claims are scientifically unsound and misleading to consumers and that eliminating them would 'aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredients list on processed foods'. Nestle and Ludwig are right to raise concerns about consumer protection and public health when it comes to front-of-package food labels, but an outright ban on front-of-package nutrition and health claims would violate the First Amendment. As nutrition policy experts develop efforts to regulate front-of-package nutrition and health claims, they should be mindful of First Amendment constraints on government regulation of commercial speech.

  7. A Brief Report

    PubMed Central

    Ali, Ather; Vitulano, Lawrence A.

    2010-01-01

    The 2010 Yale Research Symposium on Complementary and Integrative Medicine highlighted original research in related areas by Yale faculty and provided a forum to discuss and debate issues of evidence and plausibility. In this brief report, we describe selected presentations on such diverse foci as nutritional influences on cancer, acupuncture for low back pain, protein intake’s effects on bone consumption, Chinese herb-derived adjuvant chemotherapy, and the relationship between anger and cardiac arrhythmia. This symposium demonstrated that rigorous research methods are being used to study unconventional therapies and that an integrative medicine approach requires a solid scientific foundation. PMID:20885898

  8. NASA Agency Overview Briefing

    NASA Technical Reports Server (NTRS)

    2006-01-01

    The briefing opened with Dean Acosta (NASA Press Secretary) introducing Michael Griffin (NASA Administrator) and Bill Gerstenmaier (Associate Administrator for Space Operations). Bill Griffin stated that they would resume the Shuttle Fight to Return process, that the vehicle was remarkably clean and if the weather was good, the Shuttle would be ready to launch as scheduled. Bill Gerstenmaier stated that the preparations and processing of the vehicle went extremely well and they are looking forward to increasing the crew size to three. Then the floor was open to questions from the press.

  9. Hurricane Gilbert briefing

    NASA Astrophysics Data System (ADS)

    Bush, Susan M.

    Hurricane Gilbert has been called one of the most monstrous hurricanes of the 20th century, cutting a nearly 2000-mile swath across Jamaica, Mexico's Yucatan Peninsula, and along the border of Texas and Mexico September 10-17. Death toll was about 200, and damage estimates were above $8 billion.A briefing on the effects of Gilbert was held in Washington, D.C., on October 24. It was sponsored by the Committee on Natural Disasters of the National Academy of Sciences, with the Office of U.S. Foreign Disaster Assistance and the National Oceanic and Atmospheric Administration.

  10. Annual Research Briefs - 2006

    DTIC Science & Technology

    2006-12-01

    a round liq- uid jet by a coaxial flow of gas. D. KIM, 0. DESJARDINS, MI. HERRMANN AND P. MOIN 185 Stable and high-order accurate finite difference...Research 185 Annual Research Briefs 2006 Toward two-phase simulation of the primary breakup of a round liquid jet by a coaxial flow of gas By D. Kim, 0...gas phase. The flow solver volume fraction i) is defined as The breakup of a round liquid jet by a coaxial flow of gas 187 Vi = ’ H(G)dV, (2.9) where

  11. Odontome: A Brief Overview

    PubMed Central

    Prabhadevi, Maganur C; Sharma, Rajesh

    2011-01-01

    Odontomas are the most common type of odontogenic tumors. They are included under the benign calcified odontogenic tumors. Odontomas are basically classified into two types, complex and compound odontomes. Various theories or etiological factors are been quoted for the occurrence of odontomes. Generally, they are asymptomatic. Occasionally, signs and symptoms relating to their presence do occur. The sole management depends upon the early diagnosis, histopathological examination and excision of these tissues. This article briefs regarding its classification, etiological factors, occurrence, differences between complex and compound odontomes, diagnosis and management. PMID:27678223

  12. Neurolaw: A brief introduction

    PubMed Central

    Petoft, Arian

    2015-01-01

    Neurolaw, as an interdisciplinary field which links the brain to law, facilitates the pathway to better understanding of human behavior in order to regulate it accurately through incorporating neuroscience achievements in legal studies. Since 1990’s, this emerging field, by study on human nervous system as a new dimension of legal phenomena, leads to a more precise explanation for human behavior to revise legal rules and decision-makings. This paper strives to bring about significantly a brief introduction to neurolaw so as to take effective steps toward exploring and expanding the scope of law and more thorough understanding of legal issues in the field at hand. PMID:25874060

  13. 49 CFR 178.602 - Preparation of packagings and packages for testing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... testing at periodic intervals only (i.e., other than initial design qualification testing), at ambient... 49 Transportation 3 2011-10-01 2011-10-01 false Preparation of packagings and packages for testing...) SPECIFICATIONS FOR PACKAGINGS Testing of Non-bulk Packagings and Packages § 178.602 Preparation of packagings...

  14. 49 CFR 178.602 - Preparation of packagings and packages for testing.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... testing at periodic intervals only (i.e., other than initial design qualification testing), at ambient... 49 Transportation 3 2012-10-01 2012-10-01 false Preparation of packagings and packages for testing...) SPECIFICATIONS FOR PACKAGINGS Testing of Non-bulk Packagings and Packages § 178.602 Preparation of packagings...

  15. 49 CFR 178.602 - Preparation of packagings and packages for testing.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... testing at periodic intervals only (i.e., other than initial design qualification testing), at ambient... 49 Transportation 3 2014-10-01 2014-10-01 false Preparation of packagings and packages for testing...) SPECIFICATIONS FOR PACKAGINGS Testing of Non-bulk Packagings and Packages § 178.602 Preparation of packagings...

  16. 40 CFR 157.27 - Unit packaging.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.27 Unit packaging. Pesticide products... for risk reduction....

  17. 40 CFR 157.27 - Unit packaging.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.27 Unit packaging. Pesticide products... for risk reduction....

  18. 40 CFR 157.27 - Unit packaging.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.27 Unit packaging. Pesticide products... for risk reduction....

  19. 40 CFR 157.27 - Unit packaging.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.27 Unit packaging. Pesticide products... for risk reduction....

  20. In-Package Chemistry Abstraction

    SciTech Connect

    E. Thomas

    2004-11-09

    This report was developed in accordance with the requirements in ''Technical Work Plan for: Regulatory Integration Modeling and Analysis of the Waste Form and Waste Package'' (BSC 2004 [DIRS 171583]). The purpose of the in-package chemistry model is to predict the bulk chemistry inside of a breached waste package and to provide simplified expressions of that chemistry as function of time after breach to Total Systems Performance Assessment for the License Application (TSPA-LA). The scope of this report is to describe the development and validation of the in-package chemistry model. The in-package model is a combination of two models, a batch reactor model that uses the EQ3/6 geochemistry-modeling tool, and a surface complexation model that is applied to the results of the batch reactor model. The batch reactor model considers chemical interactions of water with the waste package materials and the waste form for commercial spent nuclear fuel (CSNF) waste packages and codisposed waste packages that contain both high-level waste glass (HLWG) and DOE spent fuel. The surface complexation model includes the impact of fluid-surface interactions (i.e., surface complexation) on the resulting fluid composition. The model examines two types of water influx: (1) the condensation of water vapor that diffuses into the waste package, and (2) seepage water that enters the waste package from the drift as a liquid. (1) Vapor Influx Case: The condensation of vapor onto the waste package internals is simulated as pure H2O and enters at a rate determined by the water vapor pressure for representative temperature and relative humidity conditions. (2) Water Influx Case: The water entering a waste package from the drift is simulated as typical groundwater and enters at a rate determined by the amount of seepage available to flow through openings in a breached waste package. TSPA-LA uses the vapor influx case for the nominal scenario for simulations where the waste package has been

  1. Laser Welding in Electronic Packaging

    NASA Technical Reports Server (NTRS)

    2000-01-01

    The laser has proven its worth in numerous high reliability electronic packaging applications ranging from medical to missile electronics. In particular, the pulsed YAG laser is an extremely flexible and versatile too] capable of hermetically sealing microelectronics packages containing sensitive components without damaging them. This paper presents an overview of details that must be considered for successful use of laser welding when addressing electronic package sealing. These include; metallurgical considerations such as alloy and plating selection, weld joint configuration, design of optics, use of protective gases and control of thermal distortions. The primary limitations on use of laser welding electronic for packaging applications are economic ones. The laser itself is a relatively costly device when compared to competing welding equipment. Further, the cost of consumables and repairs can be significant. These facts have relegated laser welding to use only where it presents a distinct quality or reliability advantages over other techniques of electronic package sealing. Because of the unique noncontact and low heat inputs characteristics of laser welding, it is an ideal candidate for sealing electronic packages containing MEMS devices (microelectromechanical systems). This paper addresses how the unique advantages of the pulsed YAG laser can be used to simplify MEMS packaging and deliver a product of improved quality.

  2. Naval Waste Package Design Sensitivity

    SciTech Connect

    T. Schmitt

    2006-12-13

    The purpose of this calculation is to determine the sensitivity of the structural response of the Naval waste packages to varying inner cavity dimensions when subjected to a comer drop and tip-over from elevated surface. This calculation will also determine the sensitivity of the structural response of the Naval waste packages to the upper bound of the naval canister masses. The scope of this document is limited to reporting the calculation results in terms of through-wall stress intensities in the outer corrosion barrier. This calculation is intended for use in support of the preliminary design activities for the license application design of the Naval waste package. It examines the effects of small changes between the naval canister and the inner vessel, and in these dimensions, the Naval Long waste package and Naval Short waste package are similar. Therefore, only the Naval Long waste package is used in this calculation and is based on the proposed potential designs presented by the drawings and sketches in References 2.1.10 to 2.1.17 and 2.1.20. All conclusions are valid for both the Naval Long and Naval Short waste packages.

  3. Optimal segmentation and packaging process

    DOEpatents

    Kostelnik, K.M.; Meservey, R.H.; Landon, M.D.

    1999-08-10

    A process for improving packaging efficiency uses three dimensional, computer simulated models with various optimization algorithms to determine the optimal segmentation process and packaging configurations based on constraints including container limitations. The present invention is applied to a process for decontaminating, decommissioning (D and D), and remediating a nuclear facility involving the segmentation and packaging of contaminated items in waste containers in order to minimize the number of cuts, maximize packaging density, and reduce worker radiation exposure. A three-dimensional, computer simulated, facility model of the contaminated items are created. The contaminated items are differentiated. The optimal location, orientation and sequence of the segmentation and packaging of the contaminated items is determined using the simulated model, the algorithms, and various constraints including container limitations. The cut locations and orientations are transposed to the simulated model. The contaminated items are actually segmented and packaged. The segmentation and packaging may be simulated beforehand. In addition, the contaminated items may be cataloged and recorded. 3 figs.

  4. Vacuum Packaging for Microelectromechanical Systems (MEMS)

    DTIC Science & Technology

    2002-10-01

    The Vacuum Packaging for MEMS Program focused on the development of an integrated set of packaging technologies which in totality provide a low cost...high volume product-neutral vacuum packaging capability which addresses all MEMS vacuum packaging requirements. The program balanced the need for...near term component and wafer-level vacuum packaging with the development of advanced high density wafer-level packaging solutions. Three vacuum

  5. Brief resolved unexplained event

    PubMed Central

    Arane, Karen; Claudius, Ilene; Goldman, Ran D.

    2017-01-01

    Abstract Question For many years, the term apparent life-threatening event (ALTE) was associated with sudden infant death syndrome, and parents who described an acute event in their infants were sent to the hospital for admission. I understand that for infants new terminology is recommended. What is the current approach to a near-death experience of an infant? Answer A recent clinical practice guideline revised the name and definition of an ALTE to a brief resolved unexplained event (BRUE). The diagnosis of BRUE in infants younger than 1 year of age is made when infants experience 1 of the following BRUE symptoms: a brief episode (ie, less than 1 minute and usually less than 20 to 30 seconds) that is entirely resolved (infant is at baseline), which remains unexplained after the history and physical examination are completed, and includes an event characterized by cyanosis or pallor; absent, decreased, or irregular breathing; hypertonia or hypotonia; or altered responsiveness. Low-risk infants should not be admitted to the hospital and overtesting is discouraged. PMID:28115439

  6. Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).

    PubMed

    Weaver, Joyce; Grenade, Lois La; Kwon, Hyon; Avigan, Mark

    2009-01-01

    Marketed pharmaceuticals are evaluated for safety by the US Food and Drug Administration (FDA) throughout the life cycle of the products. The FDA uses data from controlled clinical trials, from postmarketing case reports reported to the FDA's Adverse Event Reporting System, from epidemiological studies, and from registries to evaluate the safety of approved products. For some products, including some products used in dermatologic medicine, risks become apparent during the postmarketing period that require additional measures beyond product labeling and routine pharmacovigilance. The FDA continues to seek additional tools to assess risk, including pharmacogenomic biomarkers for adverse drug reactions and the use of large medical record and epidemiological databases for the systematic detection and characterization of drug-associated safety outcomes.

  7. Safety evaluation for packaging (onsite) concrete-lined waste packaging

    SciTech Connect

    Romano, T.

    1997-09-25

    The Pacific Northwest National Laboratory developed a package to ship Type A, non-transuranic, fissile excepted quantities of liquid or solid radioactive material and radioactive mixed waste to the Central Waste Complex for storage on the Hanford Site.

  8. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.

    PubMed

    Rossen, Benjamin R

    2009-01-01

    On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs. The proposals come at a time when FDA has found itself under new pressure to provide seriously ill patients with early access to investigational drugs outside the framework of clinical trials. In recent years, patient advocacy groups have filed citizen petitions with FDA asking the agency to provide specific criteria to patients and sponsors seeking expanded access or to create an early approval mechanism to permit easier access to investigational therapies. Further, FDA has seen proposed federal legislation intended to ensure early patient access to investigational treatments and nearly lost a lawsuit in federal court in which terminally ill patients sought a fundamental right of access to investigational therapies under the Due Process Clause of the Constitution. The proposed rules seek to assuage patient activists, physicians, drug sponsors and other critics who contend that FDA must strike an appropriate balance between allowing patient access to promising treatments while protecting against undue risk and safeguarding the clinical trials process. Although FDA heralded the announcement of the rules as a key step forward to improving patient access, the proposal does not expand access beyond measures currently available under longstanding agency practice and, in fact, creates new regulatory barriers and disincentives to industry participation in expanded access programs. This article examines the proposal in light of historical agency regulation and recent pressures to expand access. Section II describes the historical development of FDA's statutory authority to regulate drugs and the traditional new drug approval process. Section III describes the various methods through which FDA has allowed expanded access to

  9. Packaging of solid state devices

    DOEpatents

    Glidden, Steven C.; Sanders, Howard D.

    2006-01-03

    A package for one or more solid state devices in a single module that allows for operation at high voltage, high current, or both high voltage and high current. Low thermal resistance between the solid state devices and an exterior of the package and matched coefficient of thermal expansion between the solid state devices and the materials used in packaging enables high power operation. The solid state devices are soldered between two layers of ceramic with metal traces that interconnect the devices and external contacts. This approach provides a simple method for assembling and encapsulating high power solid state devices.

  10. Alternative Packaging for Back-Illuminated Imagers

    NASA Technical Reports Server (NTRS)

    Pain, Bedabrata

    2009-01-01

    An alternative scheme has been conceived for packaging of silicon-based back-illuminated, back-side-thinned complementary metal oxide/semiconductor (CMOS) and charge-coupled-device image-detector integrated circuits, including an associated fabrication process. This scheme and process are complementary to those described in "Making a Back-Illuminated Imager With Back-Side Connections" (NPO-42839), NASA Tech Briefs, Vol. 32, No. 7 (July 2008), page 38. To avoid misunderstanding, it should be noted that in the terminology of imaging integrated circuits, "front side" or "back side" does not necessarily refer to the side that, during operation, faces toward or away from a source of light or other object to be imaged. Instead, "front side" signifies that side of a semiconductor substrate upon which the pixel pattern and the associated semiconductor devices and metal conductor lines are initially formed during fabrication, and "back side" signifies the opposite side. If the imager is of the type called "back-illuminated," then the back side is the one that faces an object to be imaged. Initially, a back-illuminated, back-side-thinned image-detector is fabricated with its back side bonded to a silicon handle wafer. At a subsequent stage of fabrication, the front side is bonded to a glass wafer (for mechanical support) and the silicon handle wafer is etched away to expose the back side. The frontside integrated circuitry includes metal input/output contact pads, which are rendered inaccessible by the bonding of the front side to the glass wafer. Hence, one of the main problems is to make the input/output contact pads accessible from the back side, which is ultimately to be the side accessible to the external world. The present combination of an alternative packaging scheme and associated fabrication process constitute a solution of the problem.

  11. Microelectronics packaging research directions for aerospace applications

    NASA Technical Reports Server (NTRS)

    Galbraith, L.

    2003-01-01

    The Roadmap begins with an assessment of needs from the microelectronics for aerospace applications viewpoint. Needs Assessment is divided into materials, packaging components, and radiation characterization of packaging.

  12. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.

    PubMed

    O'Neill, R T; Temple, R

    2012-03-01

    At the request of the Food and Drug Administration (FDA) and with its funding, the Panel on the Handling of Missing Data in Clinical Trials was created by the National Research Council's Committee on National Statistics. This panel recently published a report(1) with recommendations that will be of use not only to the FDA but also to the entire clinical trial community so that the latter can take measures to improve the conduct and analysis of clinical trials.

  13. Regulatory Advocacy Update: ASPS Comments in Response to the FDA Draft Guidance Documents on Human Cell and Tissue Products.

    PubMed

    Rubin, J Peter; D'Amico, Richard A; Rodriguez, Ricardo; Coleman, Sydney R; Cederna, Paul; Glasberg, Scot; Neumeister, Michael; Song, David H; Butler, Charles; Hume, Keith M

    2017-02-09

    The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).

  14. Large area LED package

    NASA Astrophysics Data System (ADS)

    Goullon, L.; Jordan, R.; Braun, T.; Bauer, J.; Becker, F.; Hutter, M.; Schneider-Ramelow, M.; Lang, K.-D.

    2015-03-01

    Solid state lighting using LED-dies is a rapidly growing market. LED-dies with the needed increasing luminous flux per chip area produce a lot of heat. Therefore an appropriate thermal management is required for general lighting with LEDdies. One way to avoid overheating and shorter lifetime is the use of many small LED-dies on a large area heat sink (down to 70 μm edge length), so that heat can spread into a large area while at the same time light also appears on a larger area. The handling with such small LED-dies is very difficult because they are too small to be picked with common equipment. Therefore a new concept called collective transfer bonding using a temporary carrier chip was developed. A further benefit of this new technology is the high precision assembly as well as the plane parallel assembly of the LED-dies which is necessary for wire bonding. It has been shown that hundred functional LED-dies were transferred and soldered at the same time. After the assembly a cost effective established PCB-technology was applied to produce a large-area light source consisting of many small LED-dies and electrically connected on a PCB-substrate. The top contacts of the LED-dies were realized by laminating an adhesive copper sheet followed by LDI structuring as known from PCB-via-technology. This assembly can be completed by adding converting and light forming optical elements. In summary two technologies based on standard SMD and PCB technology have been developed for panel level LED packaging up to 610x 457 mm2 area size.

  15. New Packaging for Amplifier Slabs

    SciTech Connect

    Riley, M.; Thorsness, C.; Suratwala, T.; Steele, R.; Rogowski, G.

    2015-03-18

    The following memo provides a discussion and detailed procedure for a new finished amplifier slab shipping and storage container. The new package is designed to maintain an environment of <5% RH to minimize weathering.

  16. Spack: the Supercomputing Package Manager

    SciTech Connect

    Gamblin, T.

    2013-11-09

    The HPC software ecosystem is growing larger and more complex, but software distribution mechanisms have not kept up with this trend. Tools, Libraries, and applications need to run on multiple platforms and build with multiple compliers. Increasingly, packages leverage common software components, and building any one component requires building all of its dependencies. In HPC environments, ABI-incompatible interfaces (likeMPI), binary-incompatible compilers, and cross-compiled environments converge to make the build process a combinatoric nightmare. This obstacle deters many users from adopting useful tools, and others waste countless hours building and rebuilding tools. Many package managers exist to solve these problems for typical desktop environments, but none suits the unique needs of supercomputing facilities or users. To address these problems, we have Spack, a package manager that eases the task of managing software for end-users, across multiple platforms, package versions, compilers, and ABI incompatibilities.

  17. High Frequency Electronic Packaging Technology

    NASA Technical Reports Server (NTRS)

    Herman, M.; Lowry, L.; Lee, K.; Kolawa, E.; Tulintseff, A.; Shalkhauser, K.; Whitaker, J.; Piket-May, M.

    1994-01-01

    Commercial and government communication, radar, and information systems face the challenge of cost and mass reduction via the application of advanced packaging technology. A majority of both government and industry support has been focused on low frequency digital electronics.

  18. Handling difficult materials: Aseptic packaging

    SciTech Connect

    Lieb, K.

    1994-03-01

    Since aseptic packages, or drink boxes, were introduced in the US in the early 1980s, they have been praised for their convenience and berated for their lack of recyclability. As a result, aseptic packaging collection has been linked with that of milk cartons to increase the volume. The intervening years since the introduction of aseptic packaging have seen the drink box industry aggressively trying to create a recycling market for the boxes. Communities and schools have initiated programs, and recycling firms have allocated resources to see whether recycling aseptic packaging can work. Drink boxes are now recycled in 2.3 million homes in 15 states, and in 1,655 schools in 17 states. They are typically collected in school and curbside programs with other polyethylene coated (laminated) paperboard products such a milk cartons, and then baled and shipped to five major paper companies for recycling at eight facilities.

  19. Packaged bulk micromachined triglyceride biosensor

    NASA Astrophysics Data System (ADS)

    Mohanasundaram, S. V.; Mercy, S.; Harikrishna, P. V.; Rani, Kailash; Bhattacharya, Enakshi; Chadha, Anju

    2010-02-01

    Estimation of triglyceride concentration is important for the health and food industries. Use of solid state biosensors like Electrolyte Insulator Semiconductor Capacitors (EISCAP) ensures ease in operation with good accuracy and sensitivity when compared to conventional sensors. In this paper we report on packaging of miniaturized EISCAP sensors on silicon. The packaging involves glass to silicon bonding using adhesive. Since this kind of packaging is done at room temperature, it cannot damage the thin dielectric layers on the silicon wafer unlike the high temperature anodic bonding technique and can be used for sensors with immobilized enzyme without denaturing the enzyme. The packaging also involves a teflon capping arrangement which helps in easy handling of the bio-analyte solutions. The capping solves two problems. Firstly, it helps in the immobilization process where it ensures the enzyme immobilization happens only on one pit and secondly it helps with easy transport of the bio-analyte into the sensor pit for measurements.

  20. Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings

    SciTech Connect

    DiSabatino, A; Biswas, D; DeMicco, M; Fisher, L E; Hafner, R; Haslam, J; Mok, G; Patel, C; Russell, E

    2007-04-12

    This Packaging Review Guide (PRG) provides guidance for Department of Energy (DOE) review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE Order 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his or her review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. This PRG is generally organized at the section level in a format similar to that recommended in Regulatory Guide 7.9 (RG 7.9). One notable exception is the addition of Section 9 (Quality Assurance), which is not included as a separate chapter in RG 7.9. Within each section, this PRG addresses the technical and regulatory bases for the review, the manner in which the review is accomplished, and findings that are generally applicable for a package that meets the approval standards. This Packaging Review Guide (PRG) provides guidance for DOE review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE O 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. The primary objectives of this PRG are to: (1) Summarize the regulatory requirements for package approval; (2) Describe the technical review procedures by which DOE determines that these requirements have been satisfied; (3) Establish and maintain the quality and uniformity of reviews; (4) Define the base from which to evaluate proposed changes in scope

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-05-01

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

  3. Analysis of Transitional and Turbulent Flow Through the FDA Benchmark Nozzle Model Using Laser Doppler Velocimetry.

    PubMed

    Taylor, Joshua O; Good, Bryan C; Paterno, Anthony V; Hariharan, Prasanna; Deutsch, Steven; Malinauskas, Richard A; Manning, Keefe B

    2016-09-01

    Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA's Critical Path Initiative, designed to improve the process of bringing medical products to market. Computational predictions are often used in the development of devices and reliable in vitro data is needed to validate computational results, particularly estimations of the Reynolds stresses that could play a role in damaging blood elements. The high spatial resolution of laser Doppler velocimetry (LDV) is used to collect two component velocity data within the FDA benchmark nozzle model. Two flow conditions are used to produce flow encompassing laminar, transitional, and turbulent regimes, and viscous stresses, principal Reynolds stresses, and turbulence intensities are calculated from the measured LDV velocities. Axial velocities and viscous stresses are compared to data from a prior inter-laboratory study conducted with particle image velocimetry. Large velocity gradients are observed near the wall in the nozzle throat and in the jet shear layer located in the expansion downstream of the throat, with axial velocity changing as much as 4.5 m/s over 200 μm. Additionally, maximum Reynolds shear stresses of 1000-2000 Pa are calculated in the high shear regions, which are an order of magnitude higher than the peak viscous shear stresses (<100 Pa). It is important to consider the effects of both viscous and turbulent stresses when simulating flow through medical devices. Reynolds stresses above commonly accepted hemolysis thresholds are measured in the nozzle model, indicating that hemolysis may occur under certain flow conditions. As such, the presented turbulence quantities from LDV, which are also available for download at https://fdacfd.nci.nih.gov/ , provide an ideal validation test for computational simulations that seek to characterize the flow field and to predict hemolysis within the FDA nozzle geometry.

  4. Watermarking spot colors in packaging

    NASA Astrophysics Data System (ADS)

    Reed, Alastair; Filler, TomáÅ.¡; Falkenstern, Kristyn; Bai, Yang

    2015-03-01

    In January 2014, Digimarc announced Digimarc® Barcode for the packaging industry to improve the check-out efficiency and customer experience for retailers. Digimarc Barcode is a machine readable code that carries the same information as a traditional Universal Product Code (UPC) and is introduced by adding a robust digital watermark to the package design. It is imperceptible to the human eye but can be read by a modern barcode scanner at the Point of Sale (POS) station. Compared to a traditional linear barcode, Digimarc Barcode covers the whole package with minimal impact on the graphic design. This significantly improves the Items per Minute (IPM) metric, which retailers use to track the checkout efficiency since it closely relates to their profitability. Increasing IPM by a few percent could lead to potential savings of millions of dollars for retailers, giving them a strong incentive to add the Digimarc Barcode to their packages. Testing performed by Digimarc showed increases in IPM of at least 33% using the Digimarc Barcode, compared to using a traditional barcode. A method of watermarking print ready image data used in the commercial packaging industry is described. A significant proportion of packages are printed using spot colors, therefore spot colors needs to be supported by an embedder for Digimarc Barcode. Digimarc Barcode supports the PANTONE spot color system, which is commonly used in the packaging industry. The Digimarc Barcode embedder allows a user to insert the UPC code in an image while minimizing perceptibility to the Human Visual System (HVS). The Digimarc Barcode is inserted in the printing ink domain, using an Adobe Photoshop plug-in as the last step before printing. Since Photoshop is an industry standard widely used by pre-press shops in the packaging industry, a Digimarc Barcode can be easily inserted and proofed.

  5. Polyhydroxyalkanoates (PHA) Bioplastic Packaging Materials

    DTIC Science & Technology

    2010-05-01

    FINAL REPORT Polyhydroxyalkanoates (PHA) Bioplastic Packaging Materials SERDP Project WP-1478 MAY 2010 Dr.Chris Schwier Metabolix... Bioplastic Packaging Materials 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER SI 1478 Dr. Chris Schwier 5e. TASK...polymers were produced using blends of branched, long chain-length PHA polymers with linear PHA polymers.      15. SUBJECT TERMS Bioplastic

  6. Performance-Based Funding Brief

    ERIC Educational Resources Information Center

    Washington Higher Education Coordinating Board, 2011

    2011-01-01

    A number of states have made progress in implementing performance-based funding (PFB) and accountability. This policy brief summarizes main features of performance-based funding systems in three states: Tennessee, Ohio, and Indiana. The brief also identifies key issues that states considering performance-based funding must address, as well as…

  7. New Mexico: State Policy Brief

    ERIC Educational Resources Information Center

    Corbett, Julie

    2015-01-01

    This brief is one in a series highlighting state policies, regulations, practices, laws, or other tools intended to create the necessary conditions for school and/or district turnaround. Each brief includes an overview of the relevant turnaround tool, its development process, its impact, and lessons learned that could assist other education…

  8. Galileo Science Writers' Briefing

    NASA Astrophysics Data System (ADS)

    1989-08-01

    This NASA Kennedy video production presents Part 3 of a press conference held at JPL on August 8, 1989. The briefing in its entirety covers the Galileo Project's mission design from launch to completion in 1997 and is moderated by JPL Public Information Mgr. Robert Macmillan. Part 3 of the 3 part video series centers on the Galileo science goals, which are to explore not only Jupiter but the entire Jovian system, and the individual instruments that will make these objectives possible. Dr. Torrence V. Johnson (Project Scientist) introduces Dr. Richard Young (Probe Scientist (AMES)) and Dr. Clayne M. Yeates (Acting Science Mission Design Manager) who discuss the six main instruments included on the Probe and the Orbiter experiments and instrumentation, respectively. The video is rounded out by a period in which the Science Writer's are given an opportunity to ask questions of the seven member panel.

  9. SOHO Mission Science Briefing

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Footage shows the SOHO Mission Pre-Launch Science Briefing. The moderator of the conference is Fred Brown, NASA/GSFC Public Affairs, introduces the panel members. Included are Professor Roger Bonnet, Director ESA Science Program, Dr. Wesley Huntress, Jr., NASA Associate Administrator for Space Science and Dr. Vicente Domingo, ESA SOHO Project Scientist. Also present are several members from the SOHO Team: Dr. Richard Harrison, Art Poland, and Phillip Scherrer. The discussions include understanding the phenomena of the sun, eruption of gas clouds into the atmosphere, the polishing of the mirrors for the SOHO satellite, artificial intelligence in the telescopes, and the launch and operating costs. The panel members are also seen answering questions from various NASA Centers and Paris.

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

    Cancer.gov

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

  11. Packaging food for radiation processing

    NASA Astrophysics Data System (ADS)

    Komolprasert, Vanee

    2016-12-01

    Irradiation can play an important role in reducing pathogens that cause food borne illness. Food processors and food safety experts prefer that food be irradiated after packaging to prevent post-irradiation contamination. Food irradiation has been studied for the last century. However, the implementation of irradiation on prepackaged food still faces challenges on how to assess the suitability and safety of these packaging materials used during irradiation. Irradiation is known to induce chemical changes to the food packaging materials resulting in the formation of breakdown products, so called radiolysis products (RP), which may migrate into foods and affect the safety of the irradiated foods. Therefore, the safety of the food packaging material (both polymers and adjuvants) must be determined to ensure safety of irradiated packaged food. Evaluating the safety of food packaging materials presents technical challenges because of the range of possible chemicals generated by ionizing radiation. These challenges and the U.S. regulations on food irradiation are discussed in this article.

  12. Galileo Mission Science Briefing

    NASA Technical Reports Server (NTRS)

    1989-01-01

    The first of two tapes of the Galileo Mission Science press briefing is presented. The panel is moderated by George Diller from the Kennedy Space Center (KSC) Public Affairs Office. The participants are John Conway, the director of Payload and operations at Kennedy; Donald E. Williams, Commander of STS-43, the shuttle mission which will launch the Galileo mission; John Casani, the Deputy Assistant Director of Flight Projects at the Jet Propulsion Lab (JPL); Dick Spehalski, Galileo Project Manager at JPL; and Terrence Johnson, Galileo Project Scientist at JPL. The briefing begins with an announcement of the arrival of the Galileo Orbiter at KSC. The required steps prior to the launch are discussed. The mission trajectory and gravity assists from planetary and solar flybys are reviewed. Detailed designs of the orbiter are shown. The distance that Galileo will travel from the sun precludes the use of solar energy for heat. Therefore Radioisotope heater units are used to keep the equipment at operational temperature. A video of the arrival of the spacecraft at KSC and final tests and preparations is shown. Some of the many science goals of the mission are reviewed. Another video showing an overview of the Galileo mission is presented. During the question and answer period, the issue of the use of plutonium on the mission is broached, which engenders a review of the testing methods used to ensure the safety of the capsules containing the hazardous substance. This video has actual shots of the orbiter, as it is undergoing the final preparations and tests for the mission.

  13. Galileo Mission Science Briefing

    NASA Astrophysics Data System (ADS)

    1989-07-01

    The first of two tapes of the Galileo Mission Science press briefing is presented. The panel is moderated by George Diller from the Kennedy Space Center (KSC) Public Affairs Office. The participants are John Conway, the director of Payload and operations at Kennedy; Donald E. Williams, Commander of STS-43, the shuttle mission which will launch the Galileo mission; John Casani, the Deputy Assistant Director of Flight Projects at the Jet Propulsion Lab (JPL); Dick Spehalski, Galileo Project Manager at JPL; and Terrence Johnson, Galileo Project Scientist at JPL. The briefing begins with an announcement of the arrival of the Galileo Orbiter at KSC. The required steps prior to the launch are discussed. The mission trajectory and gravity assists from planetary and solar flybys are reviewed. Detailed designs of the orbiter are shown. The distance that Galileo will travel from the sun precludes the use of solar energy for heat. Therefore Radioisotope heater units are used to keep the equipment at operational temperature. A video of the arrival of the spacecraft at KSC and final tests and preparations is shown. Some of the many science goals of the mission are reviewed. Another video showing an overview of the Galileo mission is presented. During the question and answer period, the issue of the use of plutonium on the mission is broached, which engenders a review of the testing methods used to ensure the safety of the capsules containing the hazardous substance. This video has actual shots of the orbiter, as it is undergoing the final preparations and tests for the mission.

  14. Rapid Active Sampling Package

    NASA Technical Reports Server (NTRS)

    Peters, Gregory

    2010-01-01

    A field-deployable, battery-powered Rapid Active Sampling Package (RASP), originally designed for sampling strong materials during lunar and planetary missions, shows strong utility for terrestrial geological use. The technology is proving to be simple and effective for sampling and processing materials of strength. Although this originally was intended for planetary and lunar applications, the RASP is very useful as a powered hand tool for geologists and the mining industry to quickly sample and process rocks in the field on Earth. The RASP allows geologists to surgically acquire samples of rock for later laboratory analysis. This tool, roughly the size of a wrench, allows the user to cut away swaths of weathering rinds, revealing pristine rock surfaces for observation and subsequent sampling with the same tool. RASPing deeper (.3.5 cm) exposes single rock strata in-situ. Where a geologist fs hammer can only expose unweathered layers of rock, the RASP can do the same, and then has the added ability to capture and process samples into powder with particle sizes less than 150 microns, making it easier for XRD/XRF (x-ray diffraction/x-ray fluorescence). The tool uses a rotating rasp bit (or two counter-rotating bits) that resides inside or above the catch container. The container has an open slot to allow the bit to extend outside the container and to allow cuttings to enter and be caught. When the slot and rasp bit are in contact with a substrate, the bit is plunged into it in a matter of seconds to reach pristine rock. A user in the field may sample a rock multiple times at multiple depths in minutes, instead of having to cut out huge, heavy rock samples for transport back to a lab for analysis. Because of the speed and accuracy of the RASP, hundreds of samples can be taken in one day. RASP-acquired samples are small and easily carried. A user can characterize more area in less time than by using conventional methods. The field-deployable RASP used a Ni

  15. Prevention policies addressing packaging and packaging waste: Some emerging trends.

    PubMed

    Tencati, Antonio; Pogutz, Stefano; Moda, Beatrice; Brambilla, Matteo; Cacia, Claudia

    2016-10-01

    Packaging waste is a major issue in several countries. Representing in industrialized countries around 30-35% of municipal solid waste yearly generated, this waste stream has steadily grown over the years even if, especially in Europe, specific recycling and recovery targets have been fixed. Therefore, an increasing attention starts to be devoted to prevention measures and interventions. Filling a gap in the current literature, this explorative paper is a first attempt to map the increasingly important phenomenon of prevention policies in the packaging sector. Through a theoretical sampling, 11 countries/states (7 in and 4 outside Europe) have been selected and analyzed by gathering and studying primary and secondary data. Results show evidence of three specific trends in packaging waste prevention policies: fostering the adoption of measures directed at improving packaging design and production through an extensive use of the life cycle assessment; raising the awareness of final consumers by increasing the accountability of firms; promoting collaborative efforts along the packaging supply chains.

  16. Think INSIDE the Box: Package Engineering

    ERIC Educational Resources Information Center

    Snyder, Mark; Painter, Donna

    2014-01-01

    Most products people purchase, keep in their homes, and often discard, are typically packaged in some way. Packaging is so prevalent in daily lives that many of take it for granted. That is by design-the expectation of good packaging is that it exists for the sake of the product. The primary purposes of any package (to contain, inform, display,…

  17. 7 CFR 58.626 - Packaging equipment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Packaging equipment. 58.626 Section 58.626 Agriculture....626 Packaging equipment. Packaging equipment designed to mechanically fill and close single service... Standards for Equipment for Packaging Frozen Desserts and Cottage Cheese. Quality Specifications for...

  18. 40 CFR 157.27 - Unit packaging.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Unit packaging. 157.27 Section 157.27 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.27 Unit packaging. Pesticide...

  19. 49 CFR 173.29 - Empty packagings.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Empty packagings. 173.29 Section 173.29... SHIPMENTS AND PACKAGINGS Preparation of Hazardous Materials for Transportation § 173.29 Empty packagings. (a) General. Except as otherwise provided in this section, an empty packaging containing only the residue of...

  20. 9 CFR 381.144 - Packaging materials.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Packaging materials. 381.144 Section... Packaging materials. (a) Edible products may not be packaged in a container which is composed in whole or in... to health. All packaging materials must be safe for the intended use within the meaning of...

  1. 9 CFR 381.144 - Packaging materials.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Packaging materials. 381.144 Section... Packaging materials. (a) Edible products may not be packaged in a container which is composed in whole or in... to health. All packaging materials must be safe for the intended use within the meaning of...

  2. 9 CFR 381.144 - Packaging materials.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Packaging materials. 381.144 Section... Packaging materials. (a) Edible products may not be packaged in a container which is composed in whole or in... to health. All packaging materials must be safe for the intended use within the meaning of...

  3. 9 CFR 381.144 - Packaging materials.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Packaging materials. 381.144 Section... Packaging materials. (a) Edible products may not be packaged in a container which is composed in whole or in... to health. All packaging materials must be safe for the intended use within the meaning of...

  4. Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

    PubMed Central

    Kim, Gilhyang; Chung, Yul Ri; Kim, Bohyun; Song, Boram; Moon, Kyung Chul

    2016-01-01

    Background Human epidermal growth factor receptor 2 (HER2) is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC) has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA) criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC) using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+) and high (2+, 3+) groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001). The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004), but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161) in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC. PMID:27725621

  5. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    PubMed Central

    Pinkerton, JoAnn V.; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

  6. FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable?

    PubMed

    Graham, Garry G; Day, Richard O; Graudins, Andis; Mohamudally, Anthoulla

    2010-04-01

    Hepatotoxicity from paracetamol is of great concern because of the considerable number of patients who develop severe toxicity from this drug. A group of senior medical practitioners, academics and scientists were brought together on June 29 and 30, 2009 by the Food and Drug Administration of USA (FDA) with the aim of providing advice on how to limit the number of cases of hepatotoxicity due to paracetamol in USA. The most contentious recommendations were the reduction in the dose of paracetamol to 650 mg and the elimination of prescription combination products of paracetamol and opiates. The first recommendation indicates that many members of the committee consider, despite much evidence to the contrary, that therapeutic doses of paracetamol (up to 4 g daily) are associated with a significant incidence of hepatotoxicity. The second recommendation, if accepted by FDA, will require major changes in the therapeutic use of paracetamol and opiates. Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions.

  7. Doxil®--the first FDA-approved nano-drug: lessons learned.

    PubMed

    Barenholz, Yechezkel

    2012-06-10

    Doxil®, the first FDA-approved nano-drug (1995), is based on three unrelated principles: (i) prolonged drug circulation time and avoidance of the RES due to the use of PEGylated nano-liposomes; (ii) high and stable remote loading of doxorubicin driven by a transmembrane ammonium sulfate gradient, which also allows for drug release at the tumor; and (iii) having the liposome lipid bilayer in a "liquid ordered" phase composed of the high-T(m) (53 °C) phosphatidylcholine, and cholesterol. Due to the EPR effect, Doxil is "passively targeted" to tumors and its doxorubicin is released and becomes available to tumor cells by as yet unknown means. This review summarizes historical and scientific perspectives of Doxil development and lessons learned from its development and 20 years of its use. It demonstrates the obligatory need for applying an understanding of the cross talk between physicochemical, nano-technological, and biological principles. However, in spite of the large reward, ~2 years after Doxil-related patents expired, there is still no FDA-approved generic "Doxil" available.

  8. A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

    NASA Astrophysics Data System (ADS)

    Rogstad, Sarah; Faustino, Anneliese; Ruth, Ashley; Keire, David; Boyne, Michael; Park, Jun

    2016-11-01

    The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization. To further examine how MS is being used in successful BLAs, the applications were filtered based on the type and number of quality attributes characterized, the mass spectrometric workflows used (peptide mapping, intact mass analysis, and cleaved glycan analysis), the methods used to introduce the proteins into the gas phase (ESI, MALDI, or LC-ESI), and the specific types of instrumentation used. Analyses were conducted over a time course based on the FDA BLA approval to determine if any trends in utilization could be observed over time. Additionally, the different classes of protein-based biotherapeutics among the approved BLAs were clustered to determine if any trends could be attributed to the specific type of biotherapeutic.

  9. Generation of recombinant arenavirus for vaccine development in FDA-approved Vero cells.

    PubMed

    Cheng, Benson Y H; Ortiz-Riaño, Emilio; de la Torre, Juan Carlos; Martínez-Sobrido, Luis

    2013-08-01

    The development and implementation of arenavirus reverse genetics represents a significant breakthrough in the arenavirus field. The use of cell-based arenavirus minigenome systems together with the ability to generate recombinant infectious arenaviruses with predetermined mutations in their genomes has facilitated the investigation of the contribution of viral determinants to the different steps of the arenavirus life cycle, as well as virus-host interactions and mechanisms of arenavirus pathogenesis. In addition, the development of trisegmented arenaviruses has permitted the use of the arenavirus genome to express additional foreign genes of interest, thus opening the possibility of arenavirus-based vaccine vector applications. Likewise, the development of single-cycle infectious arenaviruses capable of expressing reporter genes provides a new experimental tool to improve the safety of research involving highly pathogenic human arenaviruses. The generation of recombinant arenaviruses using plasmid-based reverse genetics techniques has so far relied on the use of rodent cell lines, which poses some barriers for the development of Food and Drug Administration (FDA)-licensed vaccine or vaccine vectors. To overcome this obstacle, we describe here the efficient generation of recombinant arenaviruses in FDA-approved Vero cells.

  10. Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule.

    PubMed

    Bergman, Kimberly L; Krudys, K; Seo, S K; Florian, J

    2017-04-01

    Development of effective medical countermeasures for biodefense is vital to United States biopreparedness and response in the age of terrorism, both foreign and domestic. A traditional drug development pathway toward approval is not possible for most biodefense-related indications, creating the need for alternative development pathways such as the FDA's Animal Rule. Under this unique regulatory mechanism, FDA-approval is based on adequate and well-controlled animal studies when it is neither ethical nor feasible to conduct human efficacy studies. Translation of animal efficacy findings to humans is accomplished by use of modeling and simulation techniques. Pharmacokinetic and exposure-response modeling allow effective dosing regimens in humans to be identified, which are expected to produce similar benefit to that observed in animal models of disease. In this review, the role of modeling and simulation in determining the human dose for biodefense products developed under the Food and Drug Administration's Animal Rule regulatory pathway is discussed, and case studies illustrating the utility of modeling and simulation in this area of development are presented.

  11. Data mining of the public version of the FDA Adverse Event Reporting System.

    PubMed

    Sakaeda, Toshiyuki; Tamon, Akiko; Kadoyama, Kaori; Okuno, Yasushi

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

  12. FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials.

    PubMed

    Itani, Kamal M F; Shorr, Andrew F

    2014-01-01

    Recent guidance from the US Food and Drug Administration (FDA) on the conduct of clinical trials for acute bacterial skin and skin structure infection (ABSSSI) has changed the framework for clinical trial design and conduct. Notable changes included new disease state definitions, new primary endpoint definitions and the timing of assessments at these endpoints, and updated guidance on patient inclusion/exclusion criteria. Supportive evidence and statistical justification for the proposed noninferiority margins were described in detail. Although the updated guidelines are still considered drafts and have been adopted in some trials, they serve as the basis for study protocol discussions between pharmaceutical companies and the FDA in advancing the development of promising new agents. Not only will the new trial designs impact researchers and sponsors responsible for drug development programs, but they will also affect healthcare providers participating in clinical trials and the ways in which clinicians develop patient treatment plans based on the results of those trials. This review provides a summary of key changes that will impact future clinical trial design and outcomes.

  13. ISS-N1 makes the First FDA-approved Drug for Spinal Muscular Atrophy

    PubMed Central

    Ottesen, Eric W.

    2017-01-01

    Abstract Spinal muscular atrophy (SMA) is one of the leading genetic diseases of children and infants. SMA is caused by deletions or mutations of Survival Motor Neuron 1 (SMN1) gene. SMN2, a nearly identical copy of SMN1, cannot compensate for the loss of SMN1 due to predominant skipping of exon 7. While various regulatory elements that modulate SMN2 exon 7 splicing have been proposed, intronic splicing silencer N1 (ISS-N1) has emerged as the most promising target thus far for antisense oligonucleotide-mediated splicing correction in SMA. Upon procuring exclusive license from the University of Massachussets Medical School in 2010, Ionis Pharmaceuticals (formerly ISIS Pharamaceuticals) began clinical development of Spinraza™ (synonyms: Nusinersen, IONIS-SMNRX, ISIS-SMNRX), an antisense drug based on ISS-N1 target. Spinraza™ showed very promising results at all steps of the clinical development and was approved by US Food and Drug Administration (FDA) on December 23, 2016. Spinraza™ is the first FDA-approved treatment for SMA and the first antisense drug to restore expression of a fully functional protein via splicing correction. The success of Spinraza™ underscores the potential of intronic sequences as promising therapeutic targets and sets the stage for further improvement of antisense drugs based on advanced oligonucleotide chemistries and delivery protocols.

  14. FDA-approved neurologic devices intended for use in infants, children, and adolescents.

    PubMed

    Peña, Carlos; Bowsher, Kristen; Samuels-Reid, Joy

    2004-10-12

    The US Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n = 8) include indications for use in children as well as adults. On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in children. The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices. We review risk assessment and ways to reduce risk for neurologic devices intended for use in children. We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.

  15. USDA FSIS, FDA BAM, AOAC, and ISO culture methods BD BBL CHROMagar Listeria Media.

    PubMed

    Ritter, Vicki; Kircher, Susan; Sturm, Krista; Warns, Patty; Dick, Nancy

    2009-01-01

    BBL CHROMagar Listeria Media (CL) was evaluated for detection of Listeria monocytogenes in raw ground beef, smoked salmon, lettuce, and Brie cheese. The recovery of L. monocytogenes on CL was compared to the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM), U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), AOAC, and International Organization for Standardization (ISO) reference-plated media using the recommended pre-enrichments and selective enrichments. Of the 265 food samples tested, 140 were tested using BAM, USDA, or AOAC methods and 125 were tested using ISO methods. CL produced comparable results with the reference methods on all matrixes with a sensitivity of 99.3% and a specificity of 100%. No false negatives were found in testing the food matrixes. There was no statistical difference in recovery based on Chi-square analysis. Known isolates were evaluated, and CL had a sensitivity and specificity of 100%. The results of this study demonstrate that CL is an effective medium for the recovery and detection of L. monocytogenes in raw ground beef, smoked salmon, lettuce, and Brie cheese using FDA BAM, USDA FSIS, AOAC, and ISO culture methods.

  16. In Vitro Tolerance of Drug-Naive Staphylococcus aureus Strain FDA209P to Vancomycin

    PubMed Central

    Singh, Madhuri; Sasaki, Takashi; Morimoto, Yuh; Hishinuma, Tomomi; Hiramatsu, Keiichi

    2016-01-01

    ABSTRACT The mechanisms underlying bacterial tolerance to antibiotics are unclear. A possible adaptation strategy was explored by exposure of drug-naive methicillin-susceptible Staphylococcus aureus strain FDA209P to vancomycin in vitro. Strains surviving vancomycin treatment (vancomycin survivor strains), which appeared after 96 h of exposure, were slow-growing derivatives of the parent strain. Although the vancomycin MICs for the survivor strains were within the susceptible range, the cytokilling effects of vancomycin at 20-fold the MIC were significantly lower for the survivor strains than for the parent strain. Whole-genome sequencing demonstrated that ileS, encoding isoleucyl-tRNA synthetase (IleRS), was mutated in two of the three vancomycin survivor strains. The IleRS Y723H mutation is located close to the isoleucyl-tRNA contact site and potentially affects the affinity of IleRS binding to isoleucyl-tRNA, thereby inhibiting protein synthesis and leading to vancomycin tolerance. Introduction of the mutation encoding IleRS Y723H into FDA209P by allelic replacement successfully transferred the vancomycin tolerance phenotype. We have identified mutation of ileS to be one of the bona fide genetic events leading to the acquisition of vancomycin tolerance in S. aureus, potentially acting via inhibition of the function of IleRS. PMID:27855063

  17. 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.

  18. Green Packaging Management of Logistics Enterprises

    NASA Astrophysics Data System (ADS)

    Zhang, Guirong; Zhao, Zongjian

    From the connotation of green logistics management, we discuss the principles of green packaging, and from the two levels of government and enterprises, we put forward a specific management strategy. The management of green packaging can be directly and indirectly promoted by laws, regulations, taxation, institutional and other measures. The government can also promote new investment to the development of green packaging materials, and establish specialized institutions to identify new packaging materials, standardization of packaging must also be accomplished through the power of the government. Business units of large scale through the packaging and container-based to reduce the use of packaging materials, develop and use green packaging materials and easy recycling packaging materials for proper packaging.

  19. 75 FR 60333 - Hazardous Material; Miscellaneous Packaging Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... Hazardous Material; Miscellaneous Packaging Amendments AGENCY: Pipeline and Hazardous Materials Safety... materials packages may be considered a bulk packaging. The September 1, 2006 NPRM definition for ``bulk... erroneously stated Large Packagings would contain hazardous materials without an intermediate packaging,...

  20. 49 CFR 173.24a - Additional general requirements for non-bulk packagings and packages.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... subchapter. (b) Non-bulk packaging filling limits. (1) A single or composite non-bulk packaging may be filled... gross mass marked on the packaging. (3) A single or composite non-bulk packaging which is tested and... marked on the packaging, or 1.2 if not marked. In addition: (i) A single or composite non-bulk...