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Drug Postmarketing Studies

Mwango Kashoki, MD, MPH1; Cathryn Lee, BSN, MSN, CRNP1; John Jenkins, MD1
[+] Author Affiliations
1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2013;310(22):2459. doi:10.1001/jama.2013.278901.
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To the Editor The authors of a research letter1 acknowledged the important role that postmarketing studies play in enhancing the safe and effective use of drugs and recognized the importance of the US Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007 in authorizing the FDA to require postmarketing safety studies and trials.2 However, Fain and colleagues1 also used annual FDA reports published in the Federal Register to assess the effects of the FDAAA on timely conduct of postmarketing studies and failed to consider certain data supplied in those reports and in other public information. We wish to provide some clarification.


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December 11, 2013
Kevin Fain, JD, MPH; G. Caleb Alexander, MD, MS
1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
2Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, Maryland
JAMA. 2013;310(22):2459-2460. doi:10.1001/jama.2013.278904.
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