U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
  1. Regulatory Information

GUIDANCE DOCUMENT

ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers May 2014

Final

ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products (FDA stability guidance) that published in the Federal Register of September 25, 2012.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. General issues; drug master files (DMFs); drug product manufacturing and packaging; and stability studies are discussed in this guidance and are intended to clarify the stability testing data recommendations for abbreviated new drug applications (ANDAs). In this document, the terms drug substance and active pharmaceutical ingredient (API) are used interchangeably.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.