FDA's PDUFA VIII letter proposes domestic pharma incentives — a 50% fee cut for US-anchored Phase 1 trials — plus faster reviews for some drugs.
The FDA’s next five-year reauthorization of the prescription drug user fee program will feature new incentives for domestic pharma companies, newly sped up reviews for …
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The White House is reviewing a new FDA-biopharma user fee deal that includes
FDA's CBER chief outlines a pilot to fast-track Phase 1 trials, pairing sponsors with vetted research institutions; applications…
FDA's deputy commissioner tells DIA attendees the Trump administration will keep pursuing Makary's user fee priorities as…
New initiative aims to shorten timelines from early-stage research to late-stage clinical trials through regulatory reforms.
The FDA's pace of approvals has held up despite staff cuts, with 23 novel drugs cleared by June — the most since 2023.
House Appropriations Committee directs FDA to revamp new drug development process; House passes ~$7B agency funding bill 213-210.
