FDA finalizes guidance on PSG meetings
The US Food and Drug Administration (FDA) on Monday finalized guidance to assist sponsors in their meeting requests with the agency for products subject to product-specific guidance (PSG).The final version accedes to industry’s requests to drop a recommendation giving sponsors 60 days to request a teleconference with FDA upon the publication of a new or revised PSG. It also clarifies what FDA will discuss during a PSG teleconference and clarifies expectations for when sponsors should request post-submission PSG meetings.
The guidance reflects the agency’s performance goals under the Generic Drug User Fee Amendments (GDUFA III) commitment letter, and outlines time frames and procedures for scheduling meetings to discusses the potential impact of a new or revised PSG on an applicant’s drug development program.
The guidance covers the three types of PSG meetings between applicants and FDA: pre-submission PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings.
The final guidance revises a draft version issued in February 2023. (Guidance: FDA details ANDA PSG meetings under GDUFA III, Regulatory Focus 20 February 2023)
FDA received comments from industry on the draft version that expressed a need for better alignment with its GDUFA commitments. (RELATED: Commenters on FDA’s PSG meeting guidance want better alignment with GDUFA commitments, Regulatory Focus 26 April 2023)
The final version accommodates a request by the Association for Accessible Medicines (AAM) and Teva to eliminate giving sponsors 60 days from the publication of a PSG to request a PSG teleconference.
The draft guidance stated that “applicants should submit a request for a PSG teleconference within 60 days after publication of the new or revised PSG so that FDA can provide timely feedback to applicants.” It added that applicants can request a PSG teleconference more than 60 days after publication of the new or revised PSG, yet the 30-day time frame for conducting PSG teleconferences “is only applicable for complete packages submitted within 60 days after publication of the PSG.”
Both AAM and Teva urged FDA to drop the 60-day deadline. AAM stated in its comments that the 60-day requirement “is not in the Commitment Letter… the timing of publication of new or revised PSGs is unpredictable, and applicants, who may be juggling multiple applications, should have the flexibility to request PSG teleconferences when they are ready to address the issue with a particular application. Even if the request is submitted more than 60 days after the PSG is published, FDA must honor its commitment to conduct the teleconference within 30 days.”
However, FDA rejected AAM and Teva’s suggestion that it eliminate the distinction in the guidance between pre- and post-submission teleconferences. AAM said this delineation was not included in the commitment letter and was “inappropriate.”
The final guidance adds new text stating what sponsors can expect from FDA during a PSG teleconference. “During a PSG teleconference, FDA will discuss the recommendations in the PSG and provide feedback on the potential impact of the recommendations in the PSG on the applicant’s development program,” the guidance states.
It further notes that during these meetings, FDA may “recommend a path for future communication with FDA, such as controlled correspondence, pre-submission PSG meeting, post-submission PSG meeting, or other meeting type for an applicant to seek feedback from FDA to ensure that any proposed changes or additions to an applicant’s development program would be an acceptable approach to demonstrate BE in accordance with the relevant statutes and regulations.”
The final guidance also clarifies when sponsor should request post-submission PSG meetings. FDA said these meetings should be requested “prior to responding to the BE deficiency identified in the CRL involving recommendations in the new or revised PSG. After a CRL, as an alternative to a post-submission PSG meeting, ANDA applicants can consider submitting a controlled correspondence or requesting another meeting type, such as a post-CRL scientific meeting, as appropriate, to seek feedback from FDA.”
AAM told Focus that they are still reviewing the final guidance and cannot yet comment.
Guidance
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