GeneralLast reviewed May 2026

Center for Drug Evaluation and Research(CDER)

The FDA center responsible for ensuring that drugs marketed in the United States are safe and effective.

Usage Examples

The CDER Office of New Drugs assigned the NDA to the oncology review division.
CDER convened an advisory committee to review the benefit-risk profile.
The sponsor's pre-NDA meeting with CDER established the pivotal trial design.

What is CDER?

The Center for Drug Evaluation and Research (CDER) is the FDA center that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER reviews NDA and ANDA submissions for small-molecule drugs and certain biologics transferred from CBER in the 2003 reorganization.

CDER oversees the entire drug lifecycle from IND through post-market surveillance. It sets the PDUFA review timelines, manages pre-submission meetings, runs advisory committees, and takes enforcement actions for marketed drug product violations. CDER is headquartered in Silver Spring, MD, and is organized into Offices of New Drugs, Generic Drugs, Pharmaceutical Quality, Translational Sciences, Compliance, and Surveillance and Epidemiology.

Most small-molecule programs interact exclusively with CDER. Biologics programs work with either CDER or CBER depending on the specific product category — therapeutic proteins and monoclonal antibodies fall under CDER since 2003, while vaccines, blood products, and cell and gene therapies remain with CBER.

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 FDCA, PDUFA.

FDAICHHealth Canada

When This Matters

The CDER Office of New Drugs assigned the NDA to the oncology review division.
CDER convened an advisory committee to review the benefit-risk profile.
The sponsor's pre-NDA meeting with CDER established the pivotal trial design.

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

FDCAPDUFA

Frequently Asked Questions

CDER regulates small-molecule drugs and most therapeutic biologics (monoclonal antibodies, therapeutic proteins). CBER regulates vaccines, blood and blood products, cell and gene therapies, allergenics, and tissue products. The split was reorganized in 2003 when many therapeutic biologics transferred from CBER to CDER.

FDA's Intercenter Agreement defines the default assignments. Combination products and novel therapies may require a Request for Designation (RFD) to confirm the lead center. For most small-molecule drugs and therapeutic proteins, CDER is the lead reviewer.

No, assignment is based on the product's indication and regulatory classification. The review division is determined by therapeutic area (oncology, neurology, cardiovascular, etc.). Sponsors can request meetings with the assigned division to discuss development strategy.