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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FDA-CMS communications are expected to evolve as both agencies look to improve their relationship.
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.