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Vaccines, Blood & Biologics

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Vaccines, Blood & Biologics

CBER is the FDA center responsible for regulating biological products for human use, ensuring their safety, effectiveness, and availability. CBER also educates the public to promote the safe and appropriate use of these products.

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Support for Clinical Trials Advancing Rare disease Therapeutics (START) Pilot P…
Neural Network Nodes Deep Learning Artificial Intelligence Machine Learning Model

Artificial Intelligence and Machine Learning for CBER Regulated Products
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CBER Product Approval Information

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Blood & Blood Products
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Cellular & Gene Therapy Products
Fecal transplant or fecal matter transplant (FMT). Pills or medicines with fecal microbiota to cure persistent digestive diseases such as infection by Clostridium bacteria

Fecal & Microbiota Products
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Tissue & Tissue Products
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Vaccines
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Xenotransplantation

Regulatory Oversight

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Coronavirus (COVID-19) | CBER-Regulated Biologics CBER
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Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002

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