Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility

 
• By Sarah Karlin-Smith
  
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Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

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FDA leadership is pushing staff to be more comfortable taking risks. • Source: Shutterstock

Regulatory flexibility has become a notable focus for the US Food and Drug Administration in recent years as politicians and the US public increasingly call for the agency to accept higher levels of risk and uncertainty when confronted with serious and life-threatening diseases with limited or no treatment options.

Key Takeaways

  • At a pediatric drug development meeting, leadership from the FDA’s three medical product centers agreed that the agency needs to ensure review teams are not too risk adverse and using regulatory flexibility.

The FDA’s top brass seems intent on making sure the pressure to take more risks, or at least that message,...

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