Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.
Herder, Matthew Morton, Christopher J. Doshi, Peter
Herder, Matthew
Morton, Christopher J.
Doshi, Peter
Advisor
Date
2020-03-02
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JAMA Internal Medicine
Publisher
American Medical Association
Peer Reviewed
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Article
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Description
Viewpoint article discussing the FDA’s June 2019 announcement regarding its intention to replace individual scientific reviews with integrated drug reviews for new drugs. The authors express concerns over the loss of critical data as well as the legal ramifications associated with a 2007 Congressional law and the FDA’s own Equal Voice Initiative instituted in 2008.