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FDA Faces More Tech Hurdles After Clearing AERs Backlog, And Congress Is Watching

 
• By Sarah Karlin-Smith

Congressional scrutiny of FDA’s overall document management challenges is unlikely to let up despite the agency’s clearing of its adverse event reports backlog. Rep. Michael Burgess hit FDA’s document management practices hard during the first formal hearing on the 21sy Century Cures initiative.

Processing all backlogged paper drug adverse event reports signals technological achievement for FDA, but the agency’s overall IT and digital picture may not be improving at the desired speed and Congress is taking note.

The agency on May 27 said additional data entry staff and process-re-engineering allowed it to clear the paper reports backlog...

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More from United States

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

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Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

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

 
• By Sarah Karlin-Smith and Derrick Gingery

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.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.