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Home » Final Rule Codifies Long-Standing Practice for BLAs to Reference Drug Master File Data
Final Rule Codifies Long-Standing Practice for BLAs to Reference Drug Master File Data
Approved BLAs may continue to incorporate by reference information on drug substances, drug substance intermediates, and drug products (DS/DSI/DP) contained in master files if the data were initially referenced when the application was approved, according to a final rule issued by the FDA.
