US FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Questions and Answers
22/05/2014 09:26
The USFDA has published “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers” in May 2014. This guidance contains questions and answers from public comments generated during the drafting of “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products” the final document being published in June 2013 for generics. The guideline recommends that ANDAs, and DMFs (Drug Master Files) which support ANDAs, follow ICH stability guidelines Q1A(R2), Q1B, Q1C, Q1D, Q1E. The implementation date of the Q&A is June 20, 2014. | ||
The Q&A covers 5 topic areas and is intended to clarify stability testing data recommendations for abbreviated new drug applications (ANDAs) found in the short guideline.
To view the Guideline Q&A, Click Here
To view the original Guidance, Click Here |