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.

Dictaphone
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

The US Food and Drug Administration’s rule against recording formal meetings may not be as hard and fast as suggested, although sponsors do not seem excited to exercise the option if it was available.

More from Product Reviews

More from Pink Sheet