EN PL

FDA: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers - Draft Guidance

29.08.2013
This draft guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products (stability guidance) that published on September 25, 2012. The final guidance for industry of the same title published on June 20, 2013.