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

 
• By Sarah Karlin-Smith

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 speaks at a webinar sponsored by the Alliance for a Stronger FDA
FDA Commissioner Robert Califf discussed the FDA's new rare disease hub during a 27 September Alliance for a Stronger FDA event. • Source: Screenshot from Alliance for Stronger FDA webinar

The US Food and Drug Administration’s new Rare Disease Innovation Hub will have three main functions, including methods development work that should ultimately help better determine whether a drug meets the approval threshold, FDA Commissioner Robert Califf said.

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