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Track And Trace System Could Start With RxTEC As Foundation, FDA Says

 
• By Derrick Gingery

Compromise proposal from agency would allow lot-level tracking at first, if there was a “clear path” to a more advanced system in subsequent years.

A track-and-trace compromise offered by FDA would allow implementation of many of the concepts included in an industry-preferred plan, but not preempt state laws right away.

The proposal could help move negotiations forward, but the agency seems intent on laying a foundation that eventually will allow unit-level tracking if it cannot force industry to implement that...

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Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
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More from North America

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

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.

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

 
• By Derrick Gingery

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.