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- Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidanceThe U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
- Three deaths in China’s investigator-initiated trials raise concerns over fast, low-cost clinical testingThree participants died while taking part in investigator-initiated trials in China, prompting renewed scrutiny of the country’s clinical testing practices. China’s system is prized for its low co…