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FDA Calls for Six Months of Stability Testing Data for ANDA Filers

Generic-drug makers filing ANDAs and drug master files should provide six months of stability testing data, including accelerated and long-term conditions, and data from three pilot scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs says in new draft guidance on stability testing. The move to six months of product stability data doubles the previously mandated three months of data for ANDAs.
Drug Industry Daily