The Food and Drug Administration FDA

The Food and Drug Administration  FDA
Author: Meredith A. Hickmann
Publsiher: Nova Publishers
Total Pages: 199
Release: 2003
ISBN: 9781590333877
Category: Political Science
Language: EN, FR, DE, ES & NL

The Food and Drug Administration FDA Book Excerpt:

The FDA is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and a variety of other products. These products account for 25 cents of every dollar US consumers spend. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that these products are safe, accurately labelled, and in the case of drugs and medical devices, effective. FDA's tasks include: enforcement, pre-market product evaluation and approval, post-market surveillance and investigations, publishing of regulations, conducting and monitoring of research, public education, and regulating products and processes to prevent hazards to human health. Contents: Preface; Food and Drug Administration: Selected Funding Data; Food and Drug Administration: Selected Funding and Policy Issues; US European Agricultural Trade: Food and Biotechnology Issues; Food and Drug Administration: Selected Funding and Policy Issues; Food and Drug Administration Modernisation Act of 1997 -- The Provisions; Index.

FDA Information for Consumers

FDA Information for Consumers
Author: Anonim
Publsiher: Unknown
Total Pages: 18
Release: 1984
ISBN: 1928374650XXX
Category: Consumer protection
Language: EN, FR, DE, ES & NL

FDA Information for Consumers Book Excerpt:

Enhancing Food Safety

Enhancing Food Safety
Author: National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food
Publsiher: National Academies Press
Total Pages: 588
Release: 2010-11-04
ISBN: 9780309163583
Category: Medical
Language: EN, FR, DE, ES & NL

Enhancing Food Safety 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.

Food and Drug Administration FDA

Food and Drug Administration  FDA
Author: Marcia Crosse
Publsiher: DIANE Publishing
Total Pages: 52
Release: 2011-05-01
ISBN: 1437941737
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Food and Drug Administration FDA Book Excerpt:

An increasing volume of food and medical products marketed in the U.S. are produced in foreign countries. This globalization has challenged the FDA, which is responsible for ensuring the safety of these products. In late 2008 and early 2009, FDA established overseas offices comprised of 42 total staff covering particular countries or regions. The offices develop info. that FDA officials can use to make better decisions about products manufactured in foreign countries, among other activities. This report examined: (1) the steps overseas offices have taken to help ensure the safety of imported products; and (2) the extent to which FDA has engaged in long-term strategic and workforce planning for the overseas offices. Charts and tables. A print on demand report.

Dear Consumer

Dear Consumer
Author: Anonim
Publsiher: Unknown
Total Pages: 10
Release: 198?
ISBN: 1928374650XXX
Category: Dietary supplements
Language: EN, FR, DE, ES & NL

Dear Consumer Book Excerpt:

Food and Drug Administration

Food and Drug Administration
Author: Marcia Crosse
Publsiher: DIANE Publishing
Total Pages: 81
Release: 2010-01
ISBN: 1437920705
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Food and Drug Administration Book Excerpt:

Twenty years ago, it was reported that the FDA was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products -- human drugs, biologics, and medical devices -- marketed for sale in the U.S. Since then, concerns have been raised regarding FDA's ability to meet its oversight responsibilities. This report reviews the resources supporting FDA's medical product oversight responsibilities. It examines trends in: (1) FDA's funding and staffing resources for its medical product oversight responsibilities from FY 1999 through 2008; and (2) FDA's medical product oversight responsibilities during this same period. Charts and tables.

Food and Drug Administration Advisory Committees

Food and Drug Administration Advisory Committees
Author: Institute of Medicine,Committee to Study the Use of Advisory Committees
Publsiher: National Academies Press
Total Pages: 238
Release: 1992-02-01
ISBN: 0309048370
Category: Medical
Language: EN, FR, DE, ES & NL

Food and Drug Administration Advisory Committees Book Excerpt:

Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

A Risk Characterization Framework for Decision Making at the Food and Drug Administration

A Risk Characterization Framework for Decision Making at the Food and Drug Administration
Author: Institute of Medicine,National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
Publsiher: National Academies Press
Total Pages: 206
Release: 2011-06-26
ISBN: 0309212804
Category: Medical
Language: EN, FR, DE, ES & NL

A Risk Characterization Framework for Decision Making at the Food and Drug Administration Book Excerpt:

With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.

Catalog of Food and Drug Administration FDA Information for Consumers Publications and Audiovisuals

Catalog of Food and Drug Administration  FDA  Information for Consumers  Publications and Audiovisuals
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2022
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Catalog of Food and Drug Administration FDA Information for Consumers Publications and Audiovisuals Book Excerpt:

The U.S. Food and Drug Administration presents a catalog of its publications and audiovisual materials available for consumers. The publications include materials written in English and Spanish, and feature such topics as health fraud, veterinary medicine, medical devices and diagnostics, drugs, foods, biologics, and other subjects.

FDA Regulatory Affairs

FDA Regulatory Affairs
Author: David Mantus,Douglas J. Pisano
Publsiher: CRC Press
Total Pages: 400
Release: 2014-02-28
ISBN: 1841849197
Category: Medical
Language: EN, FR, DE, ES & NL

FDA Regulatory Affairs Book Excerpt:

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

The FDA Museum

The FDA Museum
Author: United States. Food and Drug Administration
Publsiher: Unknown
Total Pages: 13
Release: 1977
ISBN: 1928374650XXX
Category: Consumer protection
Language: EN, FR, DE, ES & NL

The FDA Museum Book Excerpt:

Small Business Guide to the Food and Drug Administration FDA

Small Business Guide to the Food and Drug Administration  FDA
Author: U. S. Small U.S. Small Business Administration,U. S. Food U.S. Food and Drug Administration
Publsiher: CreateSpace
Total Pages: 28
Release: 2014-09-04
ISBN: 9781501052002
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Small Business Guide to the Food and Drug Administration FDA Book Excerpt:

The purpose of this guide is to help small businesses - usually those with fewer than 500 employees - successfully navigate the realm of regulatory measures with which he U.S. Food and Drug Administration (FDA or the Agency) protects and promotes the health of the American public. Familiarity with FDA requirements is very important for a small firm that manufactures or plans to manufacture, sell, warehouse, transport, or import any of the thousands of FDA regulated products. To reach the U.S. interstate market, these products must comply with the applicable laws and the science-based public health rules developed and enforced by FDA. Although this obligation is routinely fulfilled by hundreds of thousands of American businesses, FDA is aware that for a small firm it can present a challenge. The Agency's responsibilities are defined in some 200 federal laws, and the resulting requirements, which can be complex, cover hundreds of pages in the Code of Federal Regulations. To find their way in this extensive domain of requirements, small and start-up businesses are likely to need expert assistance. The purpose of this guide is to help satisfy this need. Chapters I-IV provide an overview of FDA's responsibilities and operations and outline the main areas where small firms are most likely to come in contact with the Agency. Chapter V provides links to information that small businesses most frequently request from FDA's product centers and the Agency's Office of Regulatory Affairs. Chapter VI lists the Agency's offices and individuals who are ready to help small firms resolve their regulatory problems. This guide is designed to help make the small firms' contacts with FDA as efficient and productive as possible. We present this document as a blueprint that firms can follow to achieve their business aims while helping FDA accomplish its public health mission.

FDA 1963 protecting Consumers of Foods Drugs Cosmetics and Household Chemicals

FDA 1963  protecting Consumers of Foods  Drugs  Cosmetics  and Household Chemicals
Author: United States. Food and Drug Administration
Publsiher: Unknown
Total Pages: 12
Release: 1963
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

FDA 1963 protecting Consumers of Foods Drugs Cosmetics and Household Chemicals Book Excerpt:

Cost Determinants of the Thai Food and Drug Administration FDA

Cost Determinants of the Thai Food and Drug Administration  FDA
Author: Wanida Kaewpanukrungsi
Publsiher: Unknown
Total Pages: 180
Release: 2000
ISBN: 9789743460074
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Cost Determinants of the Thai Food and Drug Administration FDA Book Excerpt:

Food and Drug Administration FDA

Food and Drug Administration  FDA
Author: Marcia Crosse
Publsiher: DIANE Publishing
Total Pages: 63
Release: 2011-05
ISBN: 1437942563
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Food and Drug Administration FDA Book Excerpt:

In early 2008, the FDA responded to a crisis involving the contamination of heparin, a medication used to prevent and treat blood clots, when the agency received multiple reports of adverse events involving severe allergic reactions. The crisis took place from January 2008 through May 2008, during which time FDA took several actions in its response to the crisis. This report reviewed FDA's management of the heparin crisis. This report examines: (1) how FDA prevented additional contaminated heparin from reaching U.S. consumers; (2) how FDA coordinated its response to the contaminated heparin crisis; and (3) FDA's monitoring and analysis of adverse events associated with heparin. Charts and tables. This is a print on demand report.

Food and Drug Administration

Food and Drug Administration
Author: Lisa Shames
Publsiher: DIANE Publishing
Total Pages: 60
Release: 2010-08
ISBN: 1437931324
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Food and Drug Administration Book Excerpt:

Reviews the FDA¿s strategic planning and mgmt. Leading practices in this area include developing strategies to address mgmt. challenges and results-oriented performance measures, aligning activities and resources to strategic goals, and enhancing the use of performance info. The report examined the extent to which: (1) FDA's Strategic Action Plan contains strategies to address its mgmt. challenges, and the progress FDA has reported in addressing those challenges; (2) FDA's annual performance measures are results-oriented; (3) FDA has aligned its activities and resources to support its strategic goals; and (4) FDA managers report using performance info. in decision making and applying key practices to encourage that use. Illustrations.

Inside the FDA

Inside the FDA
Author: Fran Hawthorne
Publsiher: John Wiley & Sons
Total Pages: 354
Release: 2010-12-13
ISBN: 1118040066
Category: Business & Economics
Language: EN, FR, DE, ES & NL

Inside the FDA Book Excerpt:

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.

Challenges for the FDA

Challenges for the FDA
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 128
Release: 2007-11-02
ISBN: 0309109868
Category: Medical
Language: EN, FR, DE, ES & NL

Challenges for the FDA Book Excerpt:

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.

Food and Drug Administration effect of user fees on drug approval times withdrawals and other agency activities report to the chairman Committee on Health Education Labor and Pensions U S Senate

Food and Drug Administration   effect of user fees on drug approval times  withdrawals  and other agency activities   report to the chairman  Committee on Health  Education  Labor  and Pensions  U S  Senate
Author: Anonim
Publsiher: DIANE Publishing
Total Pages: 135
Release: 2022
ISBN: 1428944745
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Food and Drug Administration effect of user fees on drug approval times withdrawals and other agency activities report to the chairman Committee on Health Education Labor and Pensions U S Senate Book Excerpt:

The Future of Drug Safety

The Future of Drug Safety
Author: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
Publsiher: National Academies Press
Total Pages: 346
Release: 2007-02-27
ISBN: 9780309133944
Category: Medical
Language: EN, FR, DE, ES & NL

The Future of Drug Safety Book Excerpt:

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.