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Home » FDA Requests Six Months of Stability Testing Data for ANDA Filers
FDA Requests Six Months of Stability Testing Data for ANDA Filers
September 28, 2012
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scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs (OGD) says in new draft guidance on stability testing.