5 December 2025
From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of regulatory highlights from November 2025.
FDA Awards Second Batch of National Priority Vouchers
6 November 2025
The FDA has awarded six additional vouchers under its Commissioner’s National Priority Voucher pilot, bringing the total to 15. The programme aims to speed up the review of products that may address critical national priorities, giving developers earlier clarity and potentially faster pathways to market. Read more
FDA launches pilot to speed up clarifications to meeting minutes
19 November 2025
The FDA has introduced a pilot programme offering sponsors a quick “Meeting Minute Clarification Opportunity” after formal meetings. The approach allows sponsors to seek rapid clarification from a single discipline, aiming to streamline communication and reduce delays in understanding regulatory feedback. Read more
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