Why Should FDA Regulate Drugs?: An Interview with Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research PDF Download
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Author:
Publisher: DIANE Publishing
ISBN: 9781422326244
Category :
Languages : en
Pages : 12
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 9781422326244
Category :
Languages : en
Pages : 12
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309179440
Category : Medical
Languages : en
Pages : 128
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Book Description
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.
Author: Center for Drug Evaluation and Research (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 64
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 9781422326831
Category :
Languages : en
Pages : 16
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Book Description
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 190
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309218136
Category : Medical
Languages : en
Pages : 292
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Book Description
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Author: U.S.-China Economic and Security Review Commission
Publisher:
ISBN:
Category : China
Languages : en
Pages : 596
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Book Description
Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 176
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158893
Category : Medical
Languages : en
Pages : 94
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Book Description
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
Author: Henry G. Grabowski
Publisher: A E I Press
ISBN:
Category : Law
Languages : en
Pages : 88
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Book Description
The authors review the empirical evidence concerning the Food and Drug Administration's effect on the rate of innovation, the delays in introducing new drugs, and the profitability of pharmaceutical research.
