6 November 2025
From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of highlights from October 2025.
FDA awards first-ever National Priority Vouchers to nine sponsors
16 October 2025
The Food and Drug Administration (FDA) has announced the first recipients of its new Commissioner’s National Priority Voucher (CNPV) pilot programme, awarding nine vouchers to sponsors whose products align with U.S. national health priorities—such as large unmet medical needs, public-health crises, domestic manufacturing, or increased medication affordability. Read more
FDA publishes CDER filing checklists to boost transparency
23 October 2025
The U.S. Food and Drug Administration (FDA) has released the internal filing checklists used by its Center for Drug Evaluation and Research (CDER) to assess whether applications are complete and ready for review. By making these checklists publicly available, the FDA aims to improve transparency, help applicants avoid filing deficiencies, and reduce delays in bringing new treatments to patients. Read more
FDA unveils overhaul to accelerate biosimilar development
29 October 2025
The Food and Drug Administration (FDA) on 29 October 2025 announced major reforms aimed at making it faster and less costly to develop biosimilar medicines—lower-cost alternatives to biologic drugs used for serious and chronic diseases. The agency’s new draft guidance proposes eliminating routine comparative human efficacy trials when advanced analytical testing can establish biosimilarity, and it signals a push to streamline “interchangeability” status for biosimilars. Read more
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