Latest From Kate Rawson
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.
With a new commissioner expected next year, a restructuring may allow the Oncology Center of Excellence to assume sign-off authority for biologics and devices along with drugs.
It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.
FDA’s “Project Optimus” draft guidance on dose optimization is in the works. Until then, randomized dosing studies need to be an IND-level conversation.
Rethinking the voting and discussion questions to advisory committees may be one way to ensure FDA gets the advice it needs.
After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.