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Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions--FDA. Proposed rule
Federal Register
|May 29, 1999
Abstract:
The Food and Drug Administration (FDA) is proposing to revise its regulations on bioavailability and bioequivalence and on the content and format of an abbreviated application to reflect current FDA policy and to correct certain typographical and inadvertent errors. This action is intended to improve the accuracy and clarity of the regulations.