United States: FDA Warning Letter Is A Stark Reminder That If You Claim Your Product Is RUO, It Has To Be RUO - Mintz

Credit: Mondaq- Published on April 8, 2024
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates...

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On April 2, the FDA issued a warning letter to Agena Bioscience Inc., alleging its product, intended for research use only (RUO)...
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