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Drug Regulation Reform--oversight: Orphan drugs

Drug Regulation Reform--oversight: Orphan drugs
Author: United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Publisher:
Total Pages: 64
Release: 1980
Genre: Drugs
ISBN:

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Drug Regulation Reform--oversight

Drug Regulation Reform--oversight
Author: United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Publisher:
Total Pages: 70
Release: 1980
Genre: Drugs
ISBN:

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Drug Regulation Reform--oversight: New drug approval process

Drug Regulation Reform--oversight: New drug approval process
Author: United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Publisher:
Total Pages: 34
Release: 1980
Genre: Drugs
ISBN:

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To America's Health

To America's Health
Author: Henry I. Miller, MD
Publisher: Hoover Institution Press
Total Pages: 128
Release: 2013-11-01
Genre: Political Science
ISBN: 081799906X

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A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.


Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 442
Release: 2011-04-03
Genre: Medical
ISBN: 0309158060

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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.


Food and Drug Administration Advisory Committees

Food and Drug Administration Advisory Committees
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 239
Release: 1992-02-01
Genre: Medical
ISBN: 0309048370

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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.


The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 103
Release: 2020-01-27
Genre: Medical
ISBN: 0309498511

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To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.


Sick Money

Sick Money
Author: Billy Kenber
Publisher: Canongate Books
Total Pages: 554
Release: 2021-10-07
Genre: Medical
ISBN: 1838850279

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THE PHARMACEUTICAL INDUSTRY IS BROKEN From the American hedge fund manager who drastically hiked the price of an AIDS pill to the children’s cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system built to drive innovation and improve patient care has been distorted to maximise profits. In Sick Money, the investigative journalist who exposed a billion-pound British price-hiking scandal goes inside the global battle over high drug prices. From secret deals to patients forced to turn to the black market, Billy Kenber reveals how medicines have become nothing more than financial assets. He offers a diagnosis of an industry in crisis - and a prescription for how it could be fixed.


The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 225
Release: 1991-02-01
Genre: Medical
ISBN: 030904491X

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Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.