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Article: Drug, biologic approvals up, review times down. (Food and Drug Administration approvals of new drugs)(Brief Article)
- Article from:
- FDA Consumer
- Article date:
- April 1, 1997
CopyrightCOPYRIGHT 1997 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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A record-setting 139 drugs and biological products were approved by FDA in 1996--an increase of 63 percent over the number approved in 1995.
FDA attributed the increase to the Prescription Drug User Fee Act five-year program, in which the agency uses fees paid by manufacturers to shorten drug review and approval times. Median approval times in 1996 were 15.4 months for drugs and 14.9 months for biologics, down from 16.5 months and 17.6 months, respectively, in 1995.
Fifty-three of the drugs approved were new molecular entities. They included three drugs for HIV (the virus that ...