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Home » BLAs Not Submitted Concurrently May Result in Refuse-to-File Actions
BLAs Not Submitted Concurrently May Result in Refuse-to-File Actions
August 6, 2007
The FDA is recommending that producers of biological drug products engaged in shared manufacturing agreements submit biologic license applications (BLAs) and supplements concurrently or risk a refuse-to-file action, according to a draft guidance issued last month.