1. Pink Sheet

All US FDA Product Centers May Merge Under Planned Agency Reorganization

 
• By Sarah Karlin-Smith

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

The Trump Administration may be about to initiate a large restructuring of the FDA. (Shutterstock)
Key Takeaways
  • CDER and CBER would cease being independent centers under a planned HHS reorganization of the FDA that would merge all of FDA's product review groups.
  • The plan circulating at the FDA and obtained by Pink Sheet is very brief and offers only high-level details.
  • One barrier for the proposed outline may be current law, which requires the FDA's tobacco center to be walled off from the rest of the agency.

All of the US Food and Drug Administration’s product review and regulatory decision-making across drugs, biologics, devices, tobacco and foods would be consolidated into one office under a reorganization plan...

The document outlines how the FDA would be divided into five offices, an idea first proposed as part of a wider Health and Human Services Department...

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