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FDA released draft guidance on using the USP pending monograph process in the drug application process.
FDA released draft guidance on July 10, 2019 that assists applicants in initiating revisions to an existing monograph or the development of a new monograph under the United States Pharmacopeial Convention–Pending Monography Process (USP–PMP) during FDA’s evaluation of a drug substance master file or drug product application. Applicants of drug approvals must comply with USP National Formulary (NF) standards, if applicable. The guidance assists these applicants in using the USP–PMP to request a revision of compendial standards.
In the past, if proposed specifications in a drug application appeared to not comply with the current USP monograph, FDA approval of the application would be delayed. Until the USP–PMP was established, there was not a process for drug developers to request changes to compendial standards for products that were not yet approved by FDA. This draft guidance describes the process for the “revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application,” including how to initiate the USP–PMP process.