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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Recent Blogs
Great New Companion Diagnostics E-Book Released Today
A valuable resource in a hot, but under-informed segment of the market
Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
My Screening Test for Screening Tests
Offering up a rare bit of regulatory certainty
The Abolish OIVD Act of 2011
A torches-and-pitchforks approach to LDT regulations
Glossary Terms
In Vitro Diagnostic
(IVD)