On August 13, 2026, the FDA (Center for Drug Evaluation and Research (“CDER”) and Center for Biologics Evaluation and Research (“CBER”)) issued final guidance addressing formal meetings between the FDA and sponsors or applicants relating to the development and review of new drugs and biological products. The guidance finalizes the previous draft from September 2023 and implements agreements from the Prescription Drug User Fee Act (PDUFA) VII negotiations.

The guidance describes categories of formal meetings and FDA response timelines for sponsors and applicants during drug and biologic development. It does not apply to abbreviated new drug applications; applications for biosimilar, including interchangeable biosimilar, products; or medical device submissions.

The guidance identifies five categories of formal meetings: Type A, Type B, Type C, Type D, and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (“INTERACT”) meetings. Type A meetings are intended for development programs facing major issues, including issues related to a clinical hold. Type B meetings include pre-investigational new drug application, pre-emergency use authorization, pre-new drug application, and pre-biologics license application meetings, as well as end-of-phase meetings. Type C meetings include meetings that do not fall within the other meeting categories, including certain early consultations on the use of biomark;ers as new surrogate endpoints. Type D meetings are intended for a limited number of targeted issues or for certain follow-up questions that raise new topics after a prior formal meeting. INTERACT meetings are intended to provide early FDA input for certain novel drug and biologic development programs before submission of an investigational new drug application.

The guidance provides that FDA response timelines are generally 14 days for Type A, Type B end-of-phase, and Type D meeting requests. For other Type B meetings, Type C meetings, and INTERACT meetings, the guidance provides a 21-day response timeline.

The guidance also addresses meeting formats, including hybrid in-person meetings, virtual face-to-face video conferences, teleconferences, and written response only meetings. The guidance states that meeting requests should identify the requested format and planned timing for submission of the meeting package, and should include a concise explanation of the purpose of the meeting and the development issues the sponsor or applicant seeks to discuss.

For more information about these and other biosimilars and related regulatory and patent developments, please visit BiologicsHQ.

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The authors would like to thank April Breyer Menon for her contributions to this article.