FDA will end its CMC Development and Readiness Pilot in April 2027 after low participation — only 21 of 27 expected drugmakers enrolled across CDER and CBER.
July 23, 2026 02:24 PM EDT
FDA to end pilot aimed at preventing production issues
The FDA said it will end a pilot that was intended to help drugmakers proactively address production issues. Few companies took advantage of the program …
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FDA names seven companies to its PreCheck pilot to speed U.S. drug manufacturing reviews after receiving more than 80…
FDA picks Eli Lilly, Regeneron, Fujifilm, Cellares, Amneal, Kriya and Kyowa Kirin for its PreCheck pilot to speed US…
In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has
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.
The White House is reviewing a new FDA-biopharma user fee deal that includes
