FDA Proposes Rule to Modernize Drug Manufacturing Registration
The proposal would cut duplicate filings for hub-and-spoke networks and improve FDA visibility into foreign supply chains, officials said.
- The FDA is proposing a rule allowing distributed manufacturing establishments to register as one single establishment, said Michael Davis, Acting Director of FDA's Center for Drug Evaluation and Research.
- Currently, regulations require each manufacturing unit in a network to register separately, creating unnecessary administrative burdens. The proposed rule would streamline this process and reduce registration costs for companies.
- Closing gaps in foreign supply chain transparency, the proposal clarifies registration requirements for foreign establishments manufacturing drug components. This gives the FDA greater ability to detect and respond to potential safety concerns.
- Under the proposed rule, companies could add, relocate, or remove units through a streamlined update process while notifying the FDA in advance of any relocation, closing a gap in real-time oversight.
- This initiative builds on broader administration efforts to revitalize American pharmaceutical manufacturing and ensure Americans have reliable access to safe, quality medicines by strengthening domestic supply chains.
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FDA moves to expose hidden foreign drug factories, strengthen domestic production in sweeping rule proposal
The Food and Drug Administration is moving forward with a regulatory overhaul to limit U.S. reliance on foreign drugs and cut red tape to allow American manufacturers to fill the space, FOX Business has learned.The FDA is proposing a new rule Friday that aims to streamline processes for American drug manufacturers while toughening regulation for foreign ones.The FDA is launching a new website to go along with the overhaul that details all the wa…
FDA proposes drug registration changes to boost supply chain transparency
The Food and Drug Administration July 10 released a proposed rule that would modernize drug establishment registration requirements, with implications for pharmaceutical manufacturers and health systems that depend on a stable medication supply chain. The proposal would create a streamlined registration process for distributed manufacturing operations that use a “hub-and-spoke” model, allowing qualifying networks to register as a single establis…
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