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US FDA To Publish Own Datasets In Latest Signal Of Enhanced Transparency

 
• By Michael Cipriano

Adverse event reporting data will also be more readily available, Commissioner Scott Gottlieb says.

The US FDA is looking to routinely publish clinical data used in regulatory decision making along with adverse event reporting data, in what appears to be just the latest effort of Commissioner Scott Gottlieb's high profile effort to enhance transparency at the agency.

Speaking at the POLITICO Pro Summit Sept. 14, Gottlieb explained that sometimes FDA develops its own datasets based on submitted...

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FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

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FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
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User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
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The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
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The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.