FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds
User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.
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Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.
On to PDUFA VII? Yes And No, Woodcock Says, With Sentiment Of Fatigue
The CDER director said the US agency is always thinking about the next iteration of the prescription drug user fee program, but added that it has not yet discussed specifics.
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US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation.