US FDA’s Califf Expects Advisory Committee Reform Talk ‘About A Year From Now’
The FDA commissioner said several aspects of the advisory committee system should be considered for updates or adjustment. A revamp effort has predated his return trip to the agency.
You may also be interested in...
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
Application could be first major test of FDA’s comfort in authorizing a product with vaccine efficacy estimated to be at or below 50%. ‘Final components’ of the request to be submitted in the coming week. In interview, Moderna CMO Burton says results are ‘really strong.’