13 February 2023 - A top official from the US FDA said he wants to see something similar to the agency’s Project Orbis program developed for cell and gene therapies, as the involvement of other “high income countries” could help attract developers, asserted Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, at the Biopharma Congress on 13 February.

At the meeting, FDA officials offered their perspectives on other policy areas, such as the use of accelerated approval for cell and gene therapies and whether the agency is raising its approval standards for new cell and gene therapies.

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