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A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

 
• By Derrick Gingery

Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.

communication
The PDUFA VII agreement will increase inspection communications between the FDA and manufacturers. • Source: Alamy

The US Food and Drug Administration is standardizing its approach to alerting applicants about site inspections during the upcoming prescription drug user fee cycle, the first time such a manufacturing provision has been included in the agreement.

When the FDA determines that a pre-approval or pre-licensure inspection will be necessary, the PDUFA VII commitment letter states...

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
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FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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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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