US FDA, Advisory Committees Rarely Disagree
A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
You may also be interested in...
Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rare Event
A new study finds the agency only approved a product despite a negative advisory committee vote six times in six years. The overall rate of agreement between the agency and advisory committees has increased since 2015.
Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?
After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.
Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?
A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.