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CMS Needs Regulatory Science, Chief Scientist To Coordinate With US FDA, Former Official Says

 
• By Derrick Gingery

Sean Tunis embraces a bigger decision-making role for CMS in product access, while FDA Commissioner nominee Robert Califf also calls for smoother FDA-CMS hand-offs, and CBER Director Peter Marks wants a quicker FDA-CDC approval and deployment process.

two lines converge
A CMS Office of Chief Scientist and Office of Regulatory Science could help it coordinate actions with the FDA, Sean Tunis argued. • Source: Alamy

The US Centers for Medicare and Medicaid Services may need a regulatory science component to improve its relationship with the Food and Drug Administration and harmonize approval and coverage policies.

Sean Tunis, a principal at Rubix Health and former CMS chief medical officer, said during the recent Innovations in Regulatory...

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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.