For US FDA, Modernizing Advisory Committees Includes How Meetings Are Scheduled
Agency officials are considering developing policies for when an advisory committee meeting is appropriate, in part because of the workload associated with them. Could fewer meetings result?
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News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, an update on the Reagan-Udall RWE Accelerator project and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
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.