Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs's Books

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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.

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292

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National Academies Press

Published Date

ISBN 10

0309218160

ISBN 13

9780309218160

Ethical Issues in Studying the Safety of Approved Drugs

A Letter Report

By: Institute of Medicine (U.S.). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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Ethical Issues in Studying the Safety of Approved Drugs

A Letter Report

By: Institute of Medicine (U.S.). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug safety. This report outlines when and how the FDA should conduct clinical trials to protect the public's health and the health of trial participants.

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ISBN 10

0309157781

ISBN 13

9780309157780

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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292

Publisher

National Academies Press

Published Date

ISBN 10

0309218160

ISBN 13

9780309218160

Safe and Effective Medicines for Children

Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)

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Safe and Effective Medicines for Children

Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

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Page Count

432

Publisher

National Academies Press

Published Date

ISBN 10

0309225493

ISBN 13

9780309225496

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

By: Institute of Medicine,Medical Follow-up Agency,Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

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An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

By: Institute of Medicine,Medical Follow-up Agency,Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

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179

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National Academies Press

Published Date

ISBN 10

0309086264

ISBN 13

9780309086264

The Future of Drug Safety

Promoting and Protecting the Health of the Public

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System

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The Future of Drug Safety

Promoting and Protecting the Health of the Public

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System

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.

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347

Publisher

National Academies Press

Published Date

ISBN 10

0309103045

ISBN 13

9780309103046

Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

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Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

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Page Count

226

Publisher

National Academies Press

Published Date

ISBN 10

0309166411

ISBN 13

9780309166416

Book's by Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical Issues in Studying the Safety of Approved Drugs

Ethical Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

The Future of Drug Safety

The Future of Drug Safety

Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes

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