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In Brief: SUPAC

This article was originally published in The Tan 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SUPAC: Draft guidance allows lower strengths for topical drug products such as gels, creams and ointments through a prior approval supplement instead of an NDA or an ANDA filing.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 The draft guidance would ease requirements for changes to a lower dosage strength by eliminating the need for in vivo studies in certain cases.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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