FDA Announces New Efforts to Expedite Generic Drug Development

The U.S. Food and Drug Administration announced a draft guidance explaining the FDA-related aspects of a process that will expedite U.S. Pharmacopeial Convention small molecule monograph updates, immediately following FDA approval, potentially allowing generic medicines to come to market faster.

• FDA says process cuts out the waiting period for pending monograph decisions by allowing companies to propose revisions to a USP monograph while their application is still pending
• FDA is also advancing guidance that explains how the industry can use its inactive ingredient database to identify inactive drug ingredients that have previously been used in FDA-approved drug products, which would ...