Woodcock On Proposed Rare Rx Approval Pathway: US FDA’s Current Flexibilities Come Too Late

 
• By Sarah Karlin-Smith

The former CDER Director spoke to the Pink Sheet about why a new statutory standard is needed for certain rare disease drug approvals. We lay out some of her thinking in part one of a multi-part series on the topic.

Two senior citizens trying to touch their toes.
FDA exercises regulatory flexibility too late for many sponsors, but a new legislative pathway could change that, Janet Woodcock says. (Shutterstock)

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