FDA Reportedly Shelves Fast-Track Drug Review Pilot Program During Leadership Vacuum: Report
Summary
The United States Food and Drug Administration has suspended its expedited drug review pilot initiative. This decision comes during a period of ongoing internal leadership uncertainty at the agency.
The U.S. Food and Drug Administration (FDA) has reportedly halted its controversial fast-track drug review pilot program amid internal turmoil and a prolonged leadership vacuum. The program was launched in June 2025 to shorten the review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission. Citing six sources and internal records, Reuters on Thursday…
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