GeneralLast reviewed May 2026

Center for Biologics Evaluation and Research(CBER)

The FDA center responsible for regulating biological products including vaccines, blood products, and cell and gene therapies.

Usage Examples

CBER's Office of Therapeutic Products reviewed the gene therapy IND amendment.
The vaccine BLA was filed with CBER and reviewed by the Office of Vaccines Research and Review.
CBER assigned the cell therapy program to a specific review team within OTP.

What is CBER?

The Center for Biologics Evaluation and Research (CBER) regulates biological products licensed under section 351 of the Public Health Service Act. Its jurisdiction includes vaccines, blood and blood components, allergenic products, human tissues for transplantation, and cell and gene therapies. The 2003 FDA reorganization transferred many therapeutic biologics (monoclonal antibodies, therapeutic proteins) to CDER, leaving CBER focused on complex biologics and advanced therapies.

CBER reviews BLA submissions for products in its scope and oversees IND applications for investigational biologics. For cell and gene therapy programs, CBER hosts the Office of Therapeutic Products (OTP), which manages the RMAT designation program, reviews complex manufacturing, and interacts heavily with sponsors throughout development.

CBER coordinates with the Office of Combination Products for products combining a biologic with a device or drug, and with CDRH for certain biologic-device combinations. Sponsors of cell or gene therapies, vaccines, and blood products will work primarily with CBER throughout the regulatory lifecycle.

Regulatory Context

This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside PHSA SECTION 351, FDCA.

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When This Matters

CBER's Office of Therapeutic Products reviewed the gene therapy IND amendment.
The vaccine BLA was filed with CBER and reviewed by the Office of Vaccines Research and Review.
CBER assigned the cell therapy program to a specific review team within OTP.

Common Mistakes

Relying on generic terminology without mapping to the active jurisdiction context.
Skipping cross-links between terms, tools, and active regulatory references.
Failing to maintain a single source of truth for regulatory definitions internally.

Related Regulations

PHSA SECTION 351FDCA

Frequently Asked Questions

Vaccines, blood and blood components, allergenic products, cellular therapies, gene therapies, human tissues and cells for transplantation, and certain devices used in manufacturing these products. Most conventional therapeutic proteins and monoclonal antibodies are now reviewed by CDER following the 2003 reorganization.

OTP is the CBER office that reviews cell and gene therapy programs. Established in 2023 as an elevation from the former Office of Tissues and Advanced Therapies, OTP handles IND and BLA review, RMAT designation, and sponsor interactions for cell and gene therapy products.

When a product combines a biologic with a device or drug, the Office of Combination Products determines the lead FDA center based on primary mode of action (PMoA). CBER is the lead when the biologic component is primary. Sponsors can request designation through an RFD if classification is ambiguous.