On April 2, the FDA issued a warning letter to Agena Bioscience Inc., alleging its product, intended for research use only (RUO), was promoted for clinical purposes and thus violated the Food, Drug, and Cosmetic Act.
In the article "FDA Warning Letter Tightens Reins On 'Research Only' Labels," published in Law360, Sheppard Mullin FDA Regulatory attorneys Scott Liebman, Dominick DiSabatino and Audrey Mercer discuss the significance of FDA's response to the matter, which indicates a broader initiative to scrutinize diagnostic products previously outside the realm of regulatory control.
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