Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Is there any policy on recording a TC with FDA (CDRH or CBER) for any type meeting (A, B, C)? Does the sponsor have to inform all participants that the conversation is being recorded? This is only to allow additional review after the call and not to establish any binding agreement?  Any guidance would be helpful.

​Hello,
This may help:

In accordance with 21 CFR Sec. 10.65(e), the authority to record meetings resides with the agency staff, not the outside party. CDRH and CBER policy is not to allow outside parties to record (by audio or video) meetings with staff in order to prevent interference with the free exchange of information.

Many FDA guidance documents also state the policy against recording meetings https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf

1. MEETING CONDUCT

Meetings will be chaired by an FDA staff member and begin with introductions and an overview

 of the agenda. FDA policy prohibits audio or visual recording of discussions at meetings..

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Lynne Witkowski RAC
Manager, Regulatory Affairs
CareFusion ( is now part of BD)
Vernon Hills IL
United States
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Original Message:
Sent: 17-Apr-2018 12:58
From: Anonymous Member
Subject: Audio recording of FDA teleconferences.

This message was posted by a user wishing to remain anonymous

Is there any policy on recording a TC with FDA (CDRH or CBER) for any type meeting (A, B, C)? Does the sponsor have to inform all participants that the conversation is being recorded? This is only to allow additional review after the call and not to establish any binding agreement?  Any guidance would be helpful.

They do not allow recording of any type at meetings.  Quite many years ago (early in career) I attended a face-to-face meeting and brought a small recording device to help me refresh, keep track, and write minutes later after the meeting - since this was my second or third knowing it was hard to keep track of things when the discussion is fast moving or many people talking.  When they saw me with it, I thought they were going to lock me away in the FDA dungeon somewhere - anyway they had some strong words about recording.  (This was CDRH in a Pre-Submission Meeting.)

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 17-Apr-2018 12:58
From: Anonymous Member
Subject: Audio recording of FDA teleconferences.

This message was posted by a user wishing to remain anonymous

Is there any policy on recording a TC with FDA (CDRH or CBER) for any type meeting (A, B, C)? Does the sponsor have to inform all participants that the conversation is being recorded? This is only to allow additional review after the call and not to establish any binding agreement?  Any guidance would be helpful.