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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 of decisions under the new regulatory pathway created by the...

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