What is the MOST appropriate action for a regulatory professional if a revised USP monograph involves a minor change during an NDA review?

In the context of regulatory affairs, especially during the review of a New Drug Application (NDA), it is important for professionals to manage any changes to the drug's specifications, such as those outlined in the United States Pharmacopeia (USP) monographs, diligently and in compliance with regulatory requirements.

When a revised USP monograph involves a minor change, obtaining approval for submission and including it in the next annual report is the most appropriate action. This approach ensures that the change is documented and communicated to the regulatory authority without impeding the ongoing review process of the NDA. According to FDA guidelines, changes that fall under the category of "minor" do not necessitate an immediate implementation or separate filing as long as they are not critical to the safety or efficacy of the drug. By including the change in the next annual report, the regulatory professional aligns with the requirement to provide updated and accurate information to the FDA while maintaining the integrity of the review process.

This course of action also allows for proper evaluation of the change in context with other aspects of the NDA and any ongoing studies or data assessments. It reflects an understanding of the balance needed between complying with regulatory requirements and ensuring that the review of the product is not delayed by non-critical updates.