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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)
Key Takeaways
  • The FDA sometimes exercises regulatory flexibility when determining whether a drug has met the statutory standard of substantial evidence, but the agency must be willing...

The FDA’s ability to exercise regulatory flexibility is not a suitable alternative to a new legislative pathway for rare disease drug developers to meet the Food, Drug, and...

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