CBER is the Center within the FDA responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER reviews some in vitro diagnostic products including any product related to testing of the blood supply, HLA products and HIV-related products.
Center for Biologics Evaluation and Research
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RUO + NGS = FDA FTW MolDx and the prisoner's dilemma
How Soon is Immediately? Does 23andMe have 15 days to comply?
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FDA Drops the Hammer on 23andMe Possibly the most devastating warning letter ever
In Vitro Diagnostic (IVD)