FDA Warning Letter Tightens Reins On 'Research Only' Labels

By Scott Liebman, Dominick DiSabatino and Audrey Mercer (April 22, 2024, 6:31 PM EDT) -- On April 2, the U.S. Food and Drug Administration posted a warning letter to Agena Bioscience Inc., alleging that Agena's product was both "adulterated" and "misbranded" under the Food, Drug and Cosmetic Act as being labeled for research use only, or RUO, but, allegedly, promoted for human clinical purposes....

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