Guidance on the Harmonization of Compendial Standards Published
FDA released draft guidance on using the USP pending monograph process in the drug application process.
FDA released draft guidance on July 10, 2019 that assists applicants in initiating revisions to an existing monograph or the development of a new monograph under the United States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 This draft guidance describes the process for the “revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product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.
Source: FDA
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
