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Health: FDA Review and Approval Times

  Premium   Download PDF Now (14 pages)
Report Type Reports and Testimonies
Report Date Feb. 21, 1996
Report No. T-PEMD-96-6
Subject
Summary:

New drug applications are moving more quickly through the Food and Drug Administration's (FDA) review and approval process, and the amount of time to obtain an application is about the same in this country and in the United Kingdom. GAO found that FDA review times for medical device applications varied 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 decrease. Whether the downturn will continue will become clear as data for additional years become available. Some aspects of new systems introduced by the European Union in 1995 for drug and medical device review are quite different from FDA's approach to medical product review, and there is great optimism within the European community about their prospects. It is too soon to know, however, whether the European Union's approach will result in more-efficient reviews while guaranteeing product safety.

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