The purpose of this document is to describe the procedures for administrative handling and regulatory review of postmarketing commitment (PMC) Annual Reports, Final Study Reports, and other PMC submissions to CBER for Biological License Applications (BLAs) and New Drug Applications (NDAs). This document also describes the process for reporting on the compliance of applicants with regard to PMC submissions as required by the Federal Food, Drug, and Cosmetic Act (the Act).

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