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Comment & Response
December 11, 2013

Drug Postmarketing Studies—Reply

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

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