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[FDA] ANDAs: Stability Testing of Drug Substances and Products

Pharmacy / Pharmaceuticals:
Life cycle of medicinal products and medical devices:

Added by: Ekaterina Chashnikova
March 12, 2024

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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