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October 28, 2013JAMA Internal Medicine77 citations

Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration

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TMThomas J. MooreCFCurt D. Furberg

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Abstract

For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.

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Moore et al. (2013) studied this question.

synapsesocial.com/papers/69d901b8183921ebcaae45f9https://doi.org/10.1001/jamainternmed.2013.11813
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