FDA Webview
X

Free FDA Notices

Bioequivalence Recommendations Available

06/08/2009

Federal Register Notice: FDA is making available final product-specific bioequivalence (BE) recommendations. The recommendations provide guidance on the design of BE studies to support ANDAs. A 5/31/07 Federal Register made available a draft guidance for industry entitled Bioequivalence Recommendations for Specific Products explaining the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. To view this notice, click here.

LATEST NEWS