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

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

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.