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...
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.
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.
There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.