FDA Issues Draft Guidance Regarding the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications

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On April 17, 2009, the FDA issued a Draft Guidance for Industry titled Submission of Summary Bioequivalence Data for ANDAs. The draft guidance provides information for applicants submitting bioequivalence studies.

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Published In: Administrative Agency Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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