1. Pink Sheet

FDA Reform Bill Gives Commissioner Fixed Term, Adds Review Board

 
• By Derrick Gingery

The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act would mandate a fixed six-year term for the FDA commissioner, according to a draft of the bill obtained by “The Pink Sheet.” FDA’s centers would receive a chief medical policy officer.

FDA could see several structural changes aimed at developing speedier product review pathways under legislation being developed by Sen. Kay Hagan.

The North Carolina Democrat’s Transforming the Regulatory Environment to Accelerate Access to Treatments Act also would mandate a fixed six-year...

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• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
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Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
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