Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
Camargo
DECEMBER 13, 2021
A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.
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