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PDUFA First: Fees To Support Device Center Staff

 
• By Derrick Gingery

To enhance combination product reviews, drug fee revenue will pay for related positions in CDRH.

Drug user fees will support staff in FDA's device center for the first time beginning in fiscal year 2018.

The move does not stem from altruism by pharmaceutical sponsors and FDA signing on to the PDUFA VI agreement. Rather,...

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House Gives US FDA More Non-User Fee Funds Than Requested

 
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A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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