FDA finalizes rule on using master files in biologics applications
The FDA on Friday issued a final rule explaining how sponsors can use master files — submissions to the agency with details on their manufacturing processes — in biologics applications, with some new tweaks to the draft version from 2019.
The final rule makes official what the FDA’s existing approach has been, which is to use master files containing product-specific information in the applications known as BLAs. Under the finalized rule, previously-approved biologics may continue to incorporate references to the drug substance, drug substance intermediate or drug product enclosed in a master file, the FDA said.
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