Drug Manufacturing Archives - Quality Solutions Now (QSN)

FDA’s Proposed Registration Rule: What Distributed Manufacturing Means for Quality Oversight
On July 10, 2026, FDA issued a proposed rule that would modernize drug manufacturing registration requirements. If finalized, the rule would create a streamlined registration pathway for distributed manufacturing establishments operating under a hub-and-spoke model. [...]
FDA PreCheck and the New Facility Readiness Mindset
On June 29, 2026, FDA announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to advance U.S. drug manufacturing and improve regulatory predictability for new domestic [...]