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FDA: Guidance for Industry: Stability Testing of Drug Substances and Products, Questions and Answers

15.05.2014
This guidance provides answers to questions from the public comments we received on the draft guidance for industry on NDAs: Stability Testing of Drug Substances and Products (FDA stability guidance) that published in the Federal Register of September 25, 2012. The final guidance for industry of the same title published in the Federal Register of June 20, 2013. Comments received on the draft of this guidance published in the Federal Register of August 27, 2013 have also been incorporated.

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