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In Brief: SUPAC

This article was originally published in The Rose Sheet

Executive Summary

SUPAC: Draft guidance allows lower strengths for topical drug products such as gels, creams and ointments through a prior approval supplement instead of an NDA or an ANDA filing. The Scale-up and Post Approval Changes Guidance for Semi-Solid Dosage Forms is being circulated in draft form for industry comment. The draft guidance would ease requirements for changes to lower dosage strength by eliminating the need for in vivo studies in certain cases. In vitro release testing would replace the in vivo study requirement. FDA is planning a public workshop to discuss the draft SUPAC-SS guidance prior to its final release...

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