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Article: Proposal to speed new uses for drugs and biologics. (processes by the Food and Drug Administration that approve new drugs)(Brief Article)
- Article from:
- FDA Consumer
- Article date:
- July 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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Ways to speed development of new and supplemental uses for approved drugs and biological products using all available data to determine effectiveness are being explored by FDA under a proposed plan.
FDA's "New Use Initiative--Evidence for Primary and Supplemental Approvals," proposed March 13, gives industry dear guidance on when the agency can determine effectiveness for a new use without the usual standard of two new clinical trials.
In some cases, for example, FDA can rely on effectiveness information extrapolated from existing data. In others, the agency can accept evidence from ...