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Stability testing

This article was originally published in The Tan Sheet

Executive Summary

Comment period extended to Dec. 8 for FDA draft guidance on "Stability Testing of Drug Substances and Drug Products," according to an Aug. 24 Federal Register notice. The former deadline was Sept. 9, but the draft is "long and complex and introduces a number of new issues," justifying a longer period for public comment, FDA says. The guidance offers recommendations concerning stability studies conducted to support NDAs, ANDAs, INDs, BLAs, PLAs and supplements ("The Tan Sheet" June 22, p. 21)...
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