Califf: Rare Disease Hub Will Develop Methods To Guide Approvability Determinations

 
• By Sarah Karlin-Smith
  
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The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.

FDA Commissioner Robert Califf
FDA Commissioner Robert Califf discussed the FDA's new rare disease hub during a 27 September Alliance for a Stronger FDA event. (Screenshot from Alliance for Stronger FDA webinar)

The US Food and Drug Administration’s new rare disease “hub” will have three main functions including methods development work that should ultimately help the agency better determine whether a drug meets the approval threshold, FDA Commissioner Robert Califf said.

Key Takeaways

  • A main function of FDA’s new rare disease hub will be to development methods that will help the agency make risk-benefit determinations, Commissioner Robert Califf said.

Califf speaking 27 September said he was “really excited about the joint effort to develop methods” between FDA’s Center for...

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