FDA - Harmonizing Compendial Standards With Drug Application Approval

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process  - new FDA 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.

See: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmonizing-compendial-standards-drug-application-approval-using-usp-pending-monograph-process

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology