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FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products - Questions and Answers
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
Content:
This draft guidance provides answers to questions from the public comments FDA received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products (stability guidance) that published on September 25, 2012.
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