CMS Needs Regulatory Science, Chief Scientist To Coordinate With US FDA, Former Official Says
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.
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Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.
Proposed Medicare national coverage policy would delay access to Alzheimer’s drugs for too long and the government should instead cover the drugs under specific conditions until research already underway comes in, Global Alzheimer’s Platform Foundation president John Dwyer argues.