Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
FDA has published a question-and-answer guidance document that supports the June 20, 2013, guidance, “ANDAs: Stability Testing of Drug Substances and Products.”
We received more than 50 questions from key stakeholders concerning topics in the Draft Guidance: ANDAs: Stability Testing of Drug Substances and Products the during the 2012 open comment period. As we reviewed the questions, we found they were complex and specific, and we were not able to address all of these topics in the final guidance. However, our commitment to stakeholder concerns led us to publish this supporting document.
The guidance addresses general issues and specific questions regarding stability testing recommendations as they relate to drug substance master files, drug product manufacturing and packaging, and amendments to pending ANDA applications. We chose the questions based on relevance and frequency and addressed those questions as completely as possible.
We plan to implement the recommendations discussed in the “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers,” on June 20, 2014.
Although this guidance is considered a final guidance, FDA will continue to accept comments to the public docket for consideration during a future revision. You may submit electronic comments to http://www.regulations.gov, or written comments to the Division of Dockets Management. Identify comments with the docket number found in brackets in the heading of the question and answer document.
The new guidance is available through the FDA’s Newly Added Guidance Documents or our Drug Guidances page.