Federal Register #2026-16452

FDA Issues Final Guidance on Formal Meetings for PDUFA Product Sponsors and Applicants

This notice announces the release of final guidance by the Food and Drug Administration (FDA) for formal meetings with sponsors or applicants of Prescription Drug User Fee Act (PDUFA) products. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Centers: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) - No OEMs or vendors are mentioned in this notice - No products or services are being requested - Key Details: - The guidance provides recommendations for managing, requesting, scheduling, and documenting formal meetings between the FDA and industry stakeholders - Intended for sponsors or applicants involved in the development and review of new drug or biological products - Includes examples to help stakeholders select appropriate meeting types - This is an informational notice only; there are no procurement requirements, product requests, or service solicitations

Description

This notice announces the availability of a final guidance for industry regarding formal meetings between the FDA and sponsors or applicants of Prescription Drug User Fee Act (PDUFA) products. The guidance outlines recommendations on meeting management practices, procedures for requesting and conducting meetings, and provides examples to assist stakeholders in selecting appropriate meeting types. It finalizes a draft issued in September 2023 and aims to facilitate the development and review of new drug or biological products regulated by the FDA's CDER and CBER centers.

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