Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry

Issue Date: July 10, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality, Drug Competition Action Plan
Status: Draft

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry

This guidance assists applicants and drug master file (MF) holders in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the United States Pharmacopeial Convention Pending Monograph Process (USP-PMP) during FDA’s evaluation of a drug master file or drug product application. 2 This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.

Download the Guidance Document