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CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues

 
• By Sue Sutter

FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.

The CDER Medical Policy Council’s review of “breakthrough therapy” designation requests for specific products and indications marks a departure from the council’s charge to take a big picture approach to addressing broader, non-product-specific policy challenges.

Nevertheless, the task of reviewing the growing number of breakthrough requests has been handed to the council to ensure consistency...

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