
FDA Releases Q&A on ANDAs and Stability Testing
FDA clarifies stability data recommendations for abbreviated new drug applications.
FDA has released
In the Q&A document, FDA clarifies the stability testing data recommendations for abbreviated new drug applications (ANDAs). According to the Q&A document, “the stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It does not apply to postapproval changes.”
FDA addresses questions related to the timing and amount of accelerated stability and long-term stability data required for an ANDA, intermediate stability study requirements, stability bracketing and matrixing, shelf-life calculation requirements, sample storage times, and more.
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