Guidance: FDA details ANDA PSG meetings under GDUFA III

The US Food and Drug Administration (FDA) last week issued draft guidance that details its thinking on conducting product-specific guidance (PSG) meetings with generic drugmakers. The document is meant to reflect the agency’s commitment to increased communication under the latest generic drug user fee deal.

Almost five months after the Generic Drug User Fee Amendments (GDUFA III) were signed into law, FDA has published another guidance that addresses performance goals negotiated with industry. The draft guidance details the agency’s performance goals and how it plans to engage sponsors. (RELATED: FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III, Regulatory Focus 5 October 2022)

The guidance also sheds light on how regulators will determine the right types of meeting depending on the stage of the sponsors application and how it will address issues such as rescheduling meetings.

FDA said the guidance proposes procedures to promote well-managed PSG meetings and ensure that meetings are scheduled and conducted in accordance with the time frames it agreed to under the GDUFA III deal.

“Specifically, this guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated in (GDUFA III),” FDA said. “And this guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter.”

FDA emphasized that it will initially rely significantly on teleconference meetings with abbreviated new drug application (ANDA) sponsors but will consider face-to-face meetings when appropriate for pre- and post-submission PSG meetings.

Under the GDUFA III deal, a prospective ANDA applicant can request a pre-submission PSG meeting if they first hold a pre-submission teleconference with FDA. The agency noted that the teleconference and subsequent pre-submission PSG meeting must have happened before the sponsor submits an application.

“As described in the GDUFA III commitment letter, an ANDA applicant is eligible to have a post-submission PSG meeting if it first requests and has a post-submission PSG teleconference with FDA,” FDA stated. “The post-submission PSG teleconference and the subsequent post-submission PSG meeting should occur before responding to a possible [bioequivalency] BE deficiency identified in a discipline review letter (DRL) or a BE deficiency identified in a complete response letter (CRL).”

Under the GDUFA III deal, FDA agreed to hold PSG teleconferences with ANDA applicants within 30 days of granting a meeting request, and only for PSG teleconference requests made within 60 days of a PSG being published.

For pre-submission PSG meetings, the agency agreed to grant or deny meeting requests within 14 days of receiving a request. If granted, FDA plans to hold the pre-submission PSG meetings within 120 days of receiving a request.

For post-submission PSG meetings, FDA agreed to grant or deny the meeting request within 14 days after receiving the request. If granted, it agrees to hold the post-submission PSG meeting within 90 days of receiving the request.

“FDA will determine whether to grant a PSG teleconference, pre-submission PSG meeting, or post-submission PSG meeting, and a response will be provided to the applicant by granting or denying the meeting request pursuant to the performance goals stated in the GDUFA III commitment letter,” the agency said. “Although applicants can request a particular meeting type and format, FDA evaluates each meeting request and determines whether the request should be granted, the final meeting type, and the appropriate format.”

Guidance

Guidance: FDA details ANDA PSG meetings under GDUFA III

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