FDA issues draft guidance on post-warning letter meetings under GDUFA III
The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified under the latest round of the Generic Drug User Fee Amendments (GDUFA III).The guidance spells out the process for how an eligible facility may request a post-warning letter meeting with FDA, regarding what corrective action the facility is taking to address current good manufacturing practice (cGMP) deficiencies described in the warning letter, how to prepare and submit a complete meeting package and how FDA will conduct the post-warning letter meeting.
The 11-page Post-Warning Letter Meetings Under GDUFA guidance, published Tuesday, specifies that under the GDUFA III commitment letter, spanning fiscal years 2023-2027, a post-warning letter meeting will “generally” occur six months or more after the facility submits an initial response to the FDA warning letter.
However, says the document, a facility may request that the meeting take place before six months after an initial response to the warner letter has submitted and FDA “may opt to grant an earlier meeting” if the agency determines it would be “beneficial to both parties.”
But, FDA explained, conducting a post-warning letter does not stop FDA regulatory actions, including those in effect prior to the meetings. “As with other meetings or written correspondence with a firm, FDA advice provided at a post-warning letter meeting is not binding” on the agency and the FDA “maintains the ability to meet with firms on other topics outside GDUFA commitments,” said the draft guidance.
These meetings may be conducted by video conference, teleconference or face-at-face at the agency’s discretion, noted FDA.
In addition, the draft document states that the complete meeting packages should be submitted electronically and “consist of” the corrective and preventive action (CAPA) plan and “any supplementary information that demonstrates that actions in progress are intended to assure systemic remediation of deficient practices at the facility.
“We anticipate that reasonable progress toward remediation is unlikely if a request for a post-warning letter meeting is filed in conjunction with or around the same time as when the firm submits its warning letter response … Therefore, the request for the meeting should be made in a separate and subsequent submission from the firm’s warning letter response,” highlighted the draft guidance.
“A facility should continue to submit warning letter responses and any subsequent updates to FDA as described in the warning letter,” the document continued, noting that post-warning letter meeting requests may only come from the facility, parent company or authorized legal representative because FDA does not accept meeting requests from third parties (i.e., customers of the facility).
The draft guidance also explains that after a facility requests a post-warning letter meeting, FDA will review the “criteria under the GDUFA III commitment letter for granting a meeting request, and review the meeting request package content … During review of the meeting package, FDA may request clarifying information.” Once its review is finalized, the document says, the facility will be notified of an agency decision to grant, deny or defer the post-warning letter meeting.
Under its GDUFA III commitments, FDA may deny a meeting request for several reasons, including if the facility fails to develop a comprehensive CAPA plan addressing all the deficiencies named in the warning letter and if the facility does not include in its meeting package information or other documentation establishing that “sufficient progress has been made toward remediation” or “the meeting package is otherwise incomplete.”
“For example,” the guidance noted, “FDA may deny a request for a meeting if the CAPA does not include a retrospective evaluation of the scope of issues, address whether other systems or facilities are affected by the problem or include supporting documentation.”
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