U.S. FDA’s No Recording Meetings Rule Already Appears Flexible

Loeb Food & Drug Administration partner Jim Czaban is quoted in an article published by Citeline’s Pink Sheet discussing how the FDA’s no recording rule for in-person meeting options may be expanding, as at least one sponsor has recorded FDA meetings for years, suggesting potential permission for others. 

Jim emphasized to the publication that one should carefully weigh the “motivation, risks and potential benefits” associated with recording an FDA meeting before formally requesting to record the meeting.

“[Recording] can damage relations with the agency and collaborative efforts most companies want to have in developing their products,” Jim said.

For sponsors considering recording meetings out of concern that FDA’s written meeting minutes may not reflect the sponsor’s interpretation of the meeting, Jim noted that “Improving the quality of the meeting package is the best way to avoid surprises or meeting minutes that aren’t what you expected.”

To read the full article, visit Pink Sheet’s website (subscription required).