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GUIDANCE DOCUMENT

ANDAs: Stability Testing of Drug Substances and Products June 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-0938
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act, and the drug master files (DMFs) that support ANDAs, follow the stability recommendations provided in the International Conference on Harmonisation (ICH) stability guidances.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0938.

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