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Virtual Advisory Committees Pose Technical And Practical Challenges For US FDA, Sponsors

 
• By Sue Sutter

Recent panel review of biologics center's intramural research programs had its share of technical glitches and involved agency speakers blindly presenting to committee members they could not see; the experience suggests the difficulties an industry sponsor with an application hanging in the balance may face if a virtual advisory committee were to be held.

retro television test pattern with please stand by technical difficulties warning
Technical issues at a recent virtual AdComm included problems with audio quality and slide presentations. • Source: Shutterstock

The Center for Biologics Evaluation and Research’s recent advisory committee on intramural research programs highlights the rather significant challenges facing sponsors and the US Food and Drug Administration if and when the agency decides to conduct an entirely virtual, application-specific AdComm.

The 8 May session of the Cellular, Tissue and Gene Therapies Advisory Committee, which lasted a little over two hours,...

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