US FDA releases Q&A guidance on stability testing of ANDAs

The US FDA has published a question-and-answer guidance document that supports the June 20, 2013, guidance, ‘ANDAs: Stability Testing of Drug Substances and Products.’ In the latest Drug Information Update, the US FDA states that they received more than 50 questions from key stakeholders concerning topics in the Draft Guidance: ANDAs: Stability Testing of Drug Substances and Products the during the 2012 open comment period. The complex and specific nature of the questions and comments prevented them from addressing all topics in the final guidance and led to the US FDA 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. The questions were chosen based on relevance and frequency.

The US FDA plans 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.

EP News BureauMumbai

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