FDA finalizes guidance on requesting post-warning letter meetings

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in requesting meetings with the agency following the receipt of a warning letter.

Requesting these meetings was a program improvement agreed upon by the agency and industry as part of the Generic Drug User Fee Amendments (GDUFA) negotiations outlined in the GDUFA III commitment letter for Fiscal Years 2023–2027.

The guidance describes the process of requesting these meetings, how to prepare and submit a meeting package, how FDA assesses meeting requests, and the agency’s criteria for granting or denying meeting requests.

According to FDA, no significant changes were made to the finalized version; only minor revisions were implemented for clarity. This guidance finalizes the draft version released in September 2023 (RELATED: FDA issues draft guidance on post—warning letter meetings under GDUFA III, Regulatory Focus, 5 September 2023).

In the GDUFA III commitment letter, FDA agreed to establish a post-warning letter meeting process for facilities to obtain preliminary feedback from FDA on the adequacy of corrective action and preventive action (CAPA) plans to resolve the inspectional deficiencies identified in the warning letter.

These meetings will take place six months after the facility submits its initial response to the FDA warning letter. The FDA may choose to allow an earlier meeting if it believes it would be beneficial for both parties.

A post-warning letter meeting does not prevent FDA from taking regulatory actions, which can occur even before this meeting takes place. Like other meetings or written communications with a company, any advice given by the FDA during these meetings is not binding. Additionally, the FDA retains the ability to meet with companies on topics unrelated to GDUFA commitments.

A meeting may be rescheduled for several reasons, such as when the FDA determines that additional information is required from the facility to address questions in the meeting package, or if essential attendees can no longer attend on the scheduled date and time due to an emergency.

If the facility cancels a meeting, FDA will consider a subsequent request to reschedule another meeting to be a second and final meeting request.  A meeting may be canceled if the facility withdraws the meeting request or the facility determines its questions have been adequately answered by any preliminary written comments from FDA.

The FDA may decide to cancel the meeting if it determines that a re-inspection is the most appropriate next step.

FDA may deny a request for a post-warning letter meeting if the CAPA plan is incomplete and does not address all items mentioned in the warning letter, or if the meeting package lacks information or documentation demonstrating sufficient progress toward remediation. Other reasons for rejecting the meeting request are if the meeting package itself is incomplete or if the facility is not eligible for the meeting.

The facility should submit material to FDA 30 calendar days before the scheduled meeting date.

FDA rejected a request from the Association for Accessible Medicines (AAM) to provide a timeline for when the agency will respond to the request regarding its decision to grant, deny, or defer the meeting. The agency also declined a request from AAM to share the minutes from these meetings.

Final guidance