GDUFA III Pre-Submission Meetings Redesigned to Cut ANDA Risk

FDA's Office of Generic Drugs has restructured the pre-submission meeting program under GDUFA III, signaling a deliberate shift toward earlier, more substantive regulatory engagement for ANDA applicants. For regulatory affairs leads and development teams navigating complex product submissions, the redesigned framework offers a formal mechanism to surface and resolve scientific and technical issues before a filing reaches the review queue, reducing the probability of refuse-to-file actions and post-submission deficiencies.

The pre-submission meeting, known as the PSUB meeting, is designed to provide constructive feedback on a proposed generic development plan and prospective submission prior to ANDA filing. Under GDUFA III, OGD has expanded the scope and introduced new features to the PSUB program. The agency outlined these changes in a May 9, 2024 webinar, covering the redesigned meeting structure, updated request preparation requirements, and guidance on when and how to utilize the program. OGD confirmed the meeting format is intended to benefit both the preparation of the ANDA submission and its regulatory assessment post-submission.

The webinar featured a hypothetical case scenario discussion led by OGD pharmacologists to illustrate how to prepare a successful pre-submission meeting request. Senior OGD leadership across bioequivalence, product quality assessment, safety and clinical evaluation, and research and standards participated in a panel discussion addressing topics pertinent to the generic drug industry. Speakers included directors from the Office of Bioequivalence, the Office of Safety and Clinical Evaluation, and the Division of Product Quality Assessment, alongside the director of the Office of Research and Standards.

OGD's supporting resources for the program include the October 2022 guidance document Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA, the GDUFA III Enhancement to the Pre-ANDA Program documentation, and MAPP 5240.10, which addresses classification of approved new drug products as complex products for generic drug development purposes. Regulatory affairs professionals preparing PSUB meeting requests should consult these documents alongside the ANDA Assessment Program GDUFA III Performance Goals to align submission timelines with agency review commitments.

The intended audience for OGD's program guidance spans generic drug manufacturers, regulatory consultants, and contractors involved in ANDA development or active submissions, as well as regulatory reviewers. Plant heads and QA directors engaged in process validation and CMC documentation for complex generics should coordinate with regulatory affairs teams early in development to determine whether a PSUB meeting request is warranted and to structure the meeting package in line with OGD's updated requirements.