Draft FDA Reorganization Would Unite All Product Centers

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.

Puzzle pieces being brought together. Concept: Merger, unity.
(Summit Art Creations/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.

All of the US Food and Drug Administration’s product review and regulatory decision-making across drugs, biologics, devices, tobacco and foods...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Medtech Insight

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By 

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.

Deals Shaping The Medtech And Diagnostics Industries, June 2025

 
• By 

An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

More from Regulation

Commission Decision Launches Pediatric And Rare Disease Expert Group

 

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By 

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.