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Comment & Response |

Drug Postmarketing Studies—Reply

Kevin Fain, JD, MPH1; G. Caleb Alexander, MD, MS2
[+] Author Affiliations
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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In Reply Dr Kashoki and colleagues provide helpful insight about progress made in decreasing the backlog of postmarketing studies from September 2007, when the FDAAA was enacted. Despite this, our research aim was broader: to examine the annual number of postmarketing studies, both required and voluntary, in each status category and the trends since the law’s enactment. The initial backlog of studies is an important part of the picture. However, since September 2007, many new postmarketing studies have been required by the FDA or voluntarily established. The data in the Agency’s Federal Register notices, upon which our analysis relied, include both the backlogged and new studies.1


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December 11, 2013
Mwango Kashoki, MD, MPH; Cathryn Lee, BSN, MSN, CRNP; John Jenkins, MD
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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