Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process, which explains the FDA-related aspects of a process where drug applicants and drug master file holders can propose the development of a new monograph or suggest revisions to an existing USP monograph during the FDA’s evaluation of a product application or drug master file.
Under the Federal Food, Drug, and Cosmetic Act, drugs must comply with applicable compendial standards, including USP and National Formulary standards, or be labeled to show all respects in which the drug differs from compendial standards.
