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FDA Drug Approval: Review Time Has Decreased in Recent Years

PEMD-96-1 Published: Oct 20, 1995. Publicly Released: Nov 07, 1995.
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Highlights

Pursuant to a congressional request, GAO provided data on the Food and Drug Administration's (FDA) new drug application (NDA) process, focusing on: (1) whether the timeliness of the review and approval process for new drugs changed in recent years; (2) the factors that distinguish NDA that are approved quickly from those that take longer to approve; (3) what distinguishes NDA that are approved from those that are not; and (4) how FDA drug approval process compares with the approval process in the United Kingdom.

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