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In this section: Vaccines, Blood & Biologics

Center for Biologics Evaluation and Research (CBER) Product Approval Information

Product Approvals and Clearances with Supporting Documents

Sub-Topic Paragraphs

Scientists in a biologic research lab with microscope, test tube and DNA helix.

CBER-Regulated Products with Supporting Documents

Platelet-Rich plasma preparation. Tube with blood in centrifuge

Cleared 510(k) Submissions

vials and test tubes

Approved New Drug Applications and Abbreviated New Drug Applications

Ui display future polygonal triangle point line healthy blue abstract medicine genome engineering vector illustration

Premarket Approvals and Humanitarian Device Exemptions

DNA, Laboratory, Stem Cell, Healthcare And Medicine, Petri Dish

Approved Cellular and Gene Therapy Products

Bottle of vaccine with syringe inserted

Vaccines Licensed for Use in the United States

Biologics Products & Establishments

Development & Approval Process (CBER)

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