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FDA POST-APPROVAL CHANGE GUIDANCES

This article was originally published in The Gold Sheet

Executive Summary

on packaging components and analytical methods will move forward based on a June workshop at which FDA and industry shared ideas and expectations for the two documents. Participants agreed that there should be less rigorous regulatory standards when changing to packaging components used in similar, approved products. While the workshop discussions on AMPAC did not benefit from a preconceived draft like the one presented by PhRMA for PACPAC, a consensus did emerge on the general handling of basic types of method changes. FDA is revising its existing SUPACs to reflect the FDAMA legislation and CFR 314.70 revisions, and is refocusing on completing its bulk drug and sterile product PAC documents.
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