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Report Of The Commissioner Of Food And Drugs
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Book Synopsis Enhancing Food Safety by : National Research Council
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Download or read book Bibliography of Publications written by and published by . This book was released on 1966 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Federal Trade Commission. Bureau of Consumer Protection Publisher : ISBN 13 : Total Pages :32 pages Book Rating :4.:/5 (31 download)
Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis FDA Approved Animal Drug Products by :
Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author :United States. General Accounting Office Publisher :DIANE Publishing ISBN 13 :1428942831 Total Pages :63 pages Book Rating :4.4/5 (289 download)
Book Synopsis Prescription drugs OxyContin abuse and diversion and efforts to address the problem : report to congressional requesters. by : United States. General Accounting Office
Download or read book Prescription drugs OxyContin abuse and diversion and efforts to address the problem : report to congressional requesters. written by United States. General Accounting Office and published by DIANE Publishing. This book was released on 2003 with total page 63 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Generic drug entry prior to patent expiration an FTC study by :
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a new postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
Book Synopsis Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies by : Institute of Medicine
Download or read book Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Book Synopsis Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease by : Institute of Medicine
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Book Synopsis Developing a National Registry of Pharmacologic and Biologic Clinical Trials by : Committee on Clinical Trial Registries
Download or read book Developing a National Registry of Pharmacologic and Biologic Clinical Trials written by Committee on Clinical Trial Registries and published by . This book was released on 2006-06-16 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry. The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.
Book Synopsis A Question Of Intent by : David Kessler
Download or read book A Question Of Intent written by David Kessler and published by Public Affairs. This book was released on 2001 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Former FDA commissioner David Kessler guides the reader through a legal thriller, telling the story of the FDA's fight with big tobacco.
Author :American Bar Association. House of Delegates Publisher :American Bar Association ISBN 13 :9781590318737 Total Pages :216 pages Book Rating :4.3/5 (187 download)
Book Synopsis Model Rules of Professional Conduct by : American Bar Association. House of Delegates
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Book Synopsis Congressional Record by : United States. Congress
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 1968 with total page 1324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription for Disaster by : Thomas J. Moore
Download or read book Prescription for Disaster written by Thomas J. Moore and published by . This book was released on 1998 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This hard-hitting expose does for prescription drugs what "Silent Spring" did for pesticides, revealing the hidden dangers of the most commonly prescribed medications--and what the consumer can do to minimize the risks of serious side effects.
Book Synopsis Food and Drug Regulation by : ADAM I. MUCHMORE
Download or read book Food and Drug Regulation written by ADAM I. MUCHMORE and published by . This book was released on 2021-03-14 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Annual Reports, 1950-1974, on the Administration of the Federal Food, Drug, and Cosmetic Act and Related Laws by : United States. Food and Drug Administration
Download or read book Annual Reports, 1950-1974, on the Administration of the Federal Food, Drug, and Cosmetic Act and Related Laws written by United States. Food and Drug Administration and published by . This book was released on 1976 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt: