Lexology February 21, 2025
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities, suggesting where industry stakeholders might encounter new oversight-related opportunities and challenges in the coming year. These guidance agendas are not set in stone, however. Because all were published in the last days of the Biden administration, the emerging Trump administration FDA will likely direct units to publish updated versions reflecting changed priorities in the near future.
Five of FDA’s centers and offices published their CY 2025 guidance agendas in early to mid-January: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER),...
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