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Comment & Response
December 11, 2013

Drug Postmarketing Studies

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

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.