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Reform of drug regulation- beyond an independent drug-safety board

Article Abstract:

The perceived inability of the FDA and the pharmaceutical industry to evaluate drugs impartially and to respond adequately to signals indicating potential drug-safety problems has created extensive support for the establishment of an independent drug-safety board. More extensive reforms designed to protect the public health better are proposed considering the limitations of the existing regulatory system, a reformed regulatory process, and controversial elements of the proposed reforms.

Author: Ray, Wayne A., Stein, C. Michael
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2006
Legal issues & crime, Government regulation (cont), Government regulation, Health Care and Social Assistance, HEALTH SERVICES, Public Health Care, Legal/Government Regulation, Administration of Public Health Programs, Health Programs-Total Govt, Administration of Human Resource Programs, Health Programs, Laws, regulations and rules, Pharmaceutical industry, Public health, United States. Food and Drug Administration

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Genetic determinants of response to warfarin during initial anticoagulation

Article Abstract:

A study to ascertain the genetic aspect of patients' ability to metabolize various doses of warfarin and the function of the doses during anticoagulation was conducted. Results showed that genetic aspects played a role in the metabolism of warfarin.

Author: Kim, Richard B., Stein, C. Michael, Roden, Dan M., Schwarz, Ute I., Ritchie, Marylyn D., Bradford, Yuki, Chun Li, Dudek, Scott M., Frye-Anderson, Amy
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2008
Science & research, Pharmaceutical Preparation Manufacturing, Anticoagulant Preparations, Research, Complications and side effects, Genetic aspects, Anticoagulants (Medicine), Anticoagulants, Warfarin, Clinical report

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Drug therapy: new drugs for rheumatoid arthritis

Article Abstract:

The properties of various new drugs for Rheumatoid arthritis, affecting approximately 1 percent of the U.S. population, are reviewed. Adverse effects and clinical use of the antagonists in rheumatoid arthritis are presented.

Author: Stein, C. Michael, Olsen, Nancy J.
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2004
Drug therapy, Rheumatoid arthritis, Properties, Antirheumatic agents

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Subjects list: United States, Dosage and administration
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