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The process by which institutional review boards oversee clinical trials needs reforms that are “big and different” so that the US can keep pace with China, FDA Commissioner Marty Makary said.
The FDA has to look “at the entire process” and shorten the time frame for clinical trial sponsors from Phase 1 meeting requests to investigational new drug applications, Makary told attendees Monday at the 2026 CMS Quality Conference in Baltimore.
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