Could FDA And CDC’s COVID-19 Vaccine AdComs Be Better Coordinated? FDA’s Marks Thinks So
Federal government needs to make sure its messaging on vaccines is harmonized, CBER director Marks says. Vaccine development could have been accelerated in pregnant, pediatric and immunocompromised populations, he notes.
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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.
Instead of waiting until after regulatory events like COVID boosters and Aduhelm, FDA should describe its decision-making process along the way to help restore public faith in the agency, former deputy commissioner Josh Sharfstein says.
Peter Marks says Acting Commissioner Janet Woodcock’s tenure running the FDA has been no different than if a permanent commissioner were in place.