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, had its share of technical glitches, including panelists who could...
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