The FDA offered advice to drug sponsors on how to revise a monograph or develop a new one in a new draft guidance.
“Historically, if during the evaluation of an application it was clear that the proposed specifications would not comply with the current monograph,” approval of the application was delayed, “in some cases pending the applicant making revisions to enable the product to meet the monograph,” the agency said.
The U.S. Pharmacopeial Convention Pending Monograph Process (USP-PMP) helps to address this problem by allowing the USP process and the FDA’s reviews to run concurrently. USP-PMP proposals should be initiated “very early” in the application process to avoid delays, and applicants should work closely with USP, the agency said.
