Sponsors Still Not Racing To Schedule In-Person Meetings With US FDA

The vast majority of meeting requests eligible for the in-person/virtual format were not requested as such, according to Center for Drug Evaluation and Research data.

The FDA expected industry to slowly embrace hybrid meetings. • Source: Shutterstock

Many sponsors have not jumped at the chance to meet with US Food and Drug Administration face-to-face once again, although the lack of enthusiasm was not surprising to agency officials.

Only about 26% of the Type A and Biosimilar Product Development Type 1 meetings, as well as about 28% of...

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PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

27 Jun 2025

• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.