April 1, 2026
Notable achievements from Commissioner Makary's first year at the FDA
Summary from today’s FDA town hall marking FDA Commissioner Makary’s first year at the agency:
- 67 new medicines approved in 2025.
- The Commissioner’s National Priority Voucher (CNPV) programme achieved an average 51-day review timeline versus 310 days for non-CNPV applications in 2025.
- 90% of CDER staff have now used the FDA’s internal AI review tool, Elsa.
- The FDA stated AI has reduced filing reviews from a process that can take up to 60 days down to “minutes”, with a goal of reducing this to just a few days.
- Every approve/reject decision in 2025 was made by the primary FDA review team.
- FDA met 100% of PDUFA target dates in 2025, compared with 92% in 2023.
- The agency is continuing efforts to streamline biosimilar development, including removing comparative efficacy studies and certain PK study requirements.
- FDA is shifting from scheduled manufacturing inspections toward surprise inspections.
- Staff turnover reportedly declined from 1.1% in May 2025 to 0.4% in January 2026, (note in April 2025 there was a large reduction in workforce at the FDA).
- FDA is digitising paper records and, with sponsor consent, using this data to help train AI systems.
- The agency stated it aims to modernise the full drug development process from Pre-IND through post-marketing to remain competitive with countries such as China and Australia.
Future 2026 goals highlighted included:
- reforming the IND/Phase 1 process
- increasing over-the-counter drug availability
- implementing one-day inspections
- and enabling continuous real-time clinical trials
Longer-term goals mentioned included treatments for:
- Type 1 diabetes
- select GI cancers
- ALS
- a universal flu vaccine
- and aging-related conditions.
