FDA Statistics Are In

1999 Application and Approval Numbers

Rockville, MD-More new drugs have been approved by the Food and Drug Administration (FDA) for the U.S. market in a shorter time period than in the past. The FDA approved 83 drug applications with a median approval time of 12.0 months in 1999. This is compared to a median approval time of 12.0 months in 1998, 14.4 months in 1997 and 15.4 months in 1996. Twenty-eight of the approvals in 1999 were for priority drugs that were approved in a median time of 6.1 months. The priority and regular approvals in 1999 included 35 new molecular entities that were approved in a median time of 11.6 months compared to a median 12.0 months in 1998 and 13.4 months in 1997.

Twenty-four user fee and non-user fee product license applications were approved in a median time of 8.37 months in 1999. Three approvals were categorized as priority and were approved in a median time of 13.8 months. A total of thirty-nine new product license applications were received for review in 1999, 10 more than were received in 1998.

Forty-one premarket approval applications were approved in the median time of 9.1 months in 1999.

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