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Retiring CDER Deputy Director: Misconception That US FDA Regulators Cannot Change

 
• By Sarah Karlin-Smith

Retiring CDER Deputy Director Douglas Throckmorton spoke to the Pink Sheet ahead of his early 2025 retirement about regulatory flexibility, AI and other topics.

woman dancing, doing back bend.
Douglas Throckmorton said it is a misconception that the FDA is not flexible. (Shutterstock)
Key Takeaways
  • Douglas Throckmorton told the Pink Sheet that the FDA is more willing to change course than it is given credit.
  • Regulatory flexibility can reinforce faith in the agency, he argued.
  • Incorporating artificial intelligence and real-world evidence into agency decision-making are two of the FDA's biggest upcoming challenges, the retiring CDER deputy director said.

Douglas Throckmorton, the retiring US Food and Drug Administration drug center deputy director, knows the agency is more

“There’s a misconception about regulators that we are sort of set in our ways, that once we make a decision that can’t be changed, there isn’t a new path that could ever be considered,” Throckmorton said

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