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Health: FDA Review Times

  Premium   Download PDF Now (17 pages)
Report Type Reports and Testimonies
Report Date May 2, 1996
Report No. T-PEMD-96-9
Subject
Summary:

New drug applications are moving more quickly through the Food and Drug Administration's (FDA) review and approval process. It now takes about the same amount of time to receive approval in the United States as it does in the United Kingdom. FDA review times for medical device applications vary widely from one year to the next. For all types of applications, the median review time rose dramatically in the early 1990s and then began to fall. Whether this downturn will continue will become clear as data for additional years become available. Some aspects of the new drug and medical device review systems introduced by the European Union (EU) in 1995 differ significantly from FDA's approach to medical product review, and there is great optimism in the EU about their prospects. However, it is still to early to tell whether the EU approach will result in more efficient reviews while ensuring product safety.

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