US regulator changes guidance for generic drug 'suitability petitions'

3 October 2023

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The US Food and Drug Administration has revised its Manual of Policies and Procedures (MAPP), in relation to suitability petitions for generic drug regulatory submissions.

The update describes the policies and procedures of the agency’s generics division, in relation to suitability petitions submitted by or on behalf of applicants.

The changes reflect Generic Drug User Fee Amendments (GDUFA) III commitments, among other things.

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