From The Corner Lab - Blog Posts

FDA Publishes Q&A on Draft Guidance - ANDAs: Stability Testing of Drug Substances and Products

Posted by Jim Menoutis on Mon, Sep 09, 2013 @ 10:15 AM

FDA published its long awaited draft guidance for industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, in the Federal Register August. 27, 2013.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 The question-and-answer draft guidance document is open for comment for the next 60 days.

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Topics: DMF, Drug Master File, Drug Substance, Drug Product, Generic Drug, ICH Stability Guidlines, FDA ANDA Guidance, CDER, OGD, Office of Generic Drugs, Stability Testing