Biologic License Application amendments

The Medical Device User Fee and Modernization Act (MDUFMA) amended the Federal Food, Drug and Cosmetic Act to provide the FDA with important new responsibilities, resources, and challenges [7]. The MDUFMA has three significant provisions (1) Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Biological License Applications (BLAs), certain supplements, and 510(k)s are now subject to fees. (2) Establishment inspections may be conducted by... 

Until recently, permission to market a biologic required two appheations one to obtain a product license appHcation (PLA) for the biologic itself and another for approval of the facility where the biologic would be prepared, that is, an establishment license application. The 1997 FDA Modernization Act amended the PHS Act by ehminating the separate product and establishment hcense applications in favor of a single biologies Hcense application (BLA), which, like the PMA or PDP for devices, includes an evaluation of compliance with appropriate quality controls and current cGMP as part of the assessment of the safety and efficacy of the product in question. 

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