Requests For In-Person Formal Meetings With US FDA Increasing, But Will They Ever Dominate Again?

FDA data suggests sponsors still seem enamored with virtual meetings, even as the FDA expands the sessions eligible for in-person attendance.

hybrid meeting
All PDUFA, BsUFA and OMUFA meetings will be eligible for the hybrid format in January 2024. • Source: Shutterstock

Sponsors seem to be warming up once again to the pre-COVID-19 pandemic norm of meeting in person with US Food and Drug Administration officials, although virtual sessions remain the majority preference.

Slightly more Type A, End of Phase II and Biosimilar Product Development Type I meetings are being requested to be...

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