US FDA’s No Recording Meetings Rule Already Appears Flexible

At least one sponsor has been recording meetings for several years, suggesting others could receive permission, but the decision comes with risks as well as benefits. As the agency again expands options for in-person meetings, sponsors may want to reflect on what works best for them.

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Before asking the FDA to record a formal meeting, sponsors should consider the potential benefits and risks of the move, attorney Jim Czaban said. • Source: Shutterstock

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