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FUTURE FDA SUPAC PROJECTS

This article was originally published in The Gold Sheet

Executive Summary

...are likely to address cross-cutting issues rather than specific dosage forms, following the lead of the guidance for lab site changes. Post-approval changes guidances already in the pipeline include a mix of dosage form-specific (sterile solutions and transdermals) and issue-oriented (packaging) docu-ments. Comparability protocols will be addressed in a joint CDER/CBER guidance as another mechanism to facilitate post-approval changes. A rewrite of the manufacturing change regulations and of SUPAC-Immediate Release is slowing the work on other PAC projects. ANDA sponsors hold a four-to-one edge over NDA sponsors in SUPAC-IR filings. While CDER reviews the industry comments on the first section of the bulk active post-approval changes document, a draft of BACPAC II is beginning to take shape. Relief for DMF holders is one industry concern.

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