Best Practices for Meeting Management; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Best Practices for Meeting Management." This workshop is being conducted to fulfill a commitment to hold a public meeting to discuss best practices for meeting management in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). The purpose of the public workshop is to discuss issues related to submission of meeting requests, efficient time management, finalizing meeting agenda, development and submission of meeting background packages, and lessons learned from the Coronavirus Disease 2019 (COVID-19) pandemic including the use of virtual meeting platforms. The public workshop will also discuss and share experience and metrics related to specific PDUFA meeting activities associated with the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) meetings in fiscal years (FYs) 2021 through 2023. This will include Type D and Initial Targeted Engagement for Regulatory Advice on CBER/ CDER Products (INTERACT) meetings, which began with PDUFA VII in FY 2023. Learnings from the public meeting could inform FDA's internal process improvement efforts and, as appropriate, be reflected in an update to the "Best Practices for Communication Between IND [Investigational New Drug Application] Sponsors and FDA During Drug Development" guidance.

Abstract as published in the Federal Register.

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