The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance Meetings Between the FDA and ANDA Applicants Under GDUFA."
The guidance provides recommendations for product-specific guidance (PSG) meetings (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings) with prospective applicants or applicants who have submitted abbreviated new drug applications (ANDAs). Also, GDUFA III Commitment Letter provides information about how to request and conduct PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings.
The guidance also details the Meeting procedures that ensure meetings are scheduled and conducted in accordance with the GDUFA III Commitment Letter timeframes.
Below are the key points of the draft guidelines:
Pre-submission meetings can help ensure the completeness of applications, reduce the number of review cycles, and improve overall communication between FDA and ANDA applicants.
FDA recommends that ANDA applicants request a pre-submission meeting at least six months prior to filing.
Meetings can be conducted in person or virtually, depending on the circumstances and availability of the parties involved.
ANDA applicants should submit a meeting request to FDA that will include a brief overview of the proposed application, specific questions or issues for discussion, and any relevant supporting information.
FDA will review the meeting request and provide a written response that will include the date, time, location, and format of the meeting, as well as a tentative agenda.
ANDA applicants should prepare a meeting packet that will include relevant background information, proposed the product designation, the design of the proposed application and any specific questions or issues for discussion.
During the meeting, FDA and ANDA applicants should discuss the proposed application, identify potential problems or deficiencies, and establish a plan to address them.
FDA will provide written minutes of the meeting that summarize the discussions, agreements, and action items arising from the meeting.
ANDA applicants should promptly address any issues or deficiencies identified during the meeting and communicate with FDA as necessary during the application review process.
It is important to note that this guidance is not intended to create new requirements or obligations for ANDA applicants, but rather to provide best practice recommendations for pre-submission meetings with FDA.
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