Virtual Adcom Vet Says In-Person Events May Be Better For Product Approval Recommendations
Syndax CEO also says US FDA’s virtual meetings would benefit from having advisory committee members on camera, which may be a technology challenge.
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Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.
The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.