Abstract
Compendial Operations Branch is the official liaison between the U.S. Pharmacopeial Convention. Inc.(USPC) and FDA's Center for Drugs and Biologies. The Branch’s responsibilities include managing the Center’s review of official compendial revisions as proposed in the Pharmacopeial Forum (PF) and directing the CMED (Compendial Monographs Evolution and Development) Program and Methods Validation Program. Insight into the process of reviews by the Branch will be described, along with a brief discussion on specific issues, including additional mechanisms involved in the liaison function.
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