FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance

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FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

FDA published the draft guidance for industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, in the Federal Register Aug. 27. The publication provides answers to questions submitted during the public comment period on the draft stability guidance that was published on Sept. 25, 2012. The final guidance for industry was published on June 20, 2013. The question-and-answer document is open for comment for the next 60 days.

FDA’s stability guidance for generic drugs recommends that the generic-drug industry follow ICH stability-related guidance. The question-and-answer guidance clarifies the effect of the stability guidance on drug master file holders, discusses questions related to manufacturing and packaging, offers recommendations for amendments to pending abbreviated new drug applications, and answers other questions about stability studies.