FDA Proposes Rule to Modernize Drug Manufacturing Registration

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. The proposed rule would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the U.S. drug supply.This action is another step forward in the FDA’s coordinated effort to help ensure Americans have reliable access to safe, quality medicines by strengthening domestic pharmaceutical manufacturing, and ensuring that regulatory frameworks kee...