Direct comparison
CBER vs. CDER: FDA Center Jurisdiction
CBER reviews vaccines, blood, and cell/gene therapies. CDER reviews small-molecule drugs and most therapeutic biologics. How jurisdiction is actually decided.
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How do CBER, CDER compare side by side?
The table below compares CBER, CDER across 14 procurement-relevant dimensions, from full name through what the 2020 bpcia "deemed to be a license" event actually changed.
Side-by-side comparison
| Dimension | CBER | CDER |
|---|---|---|
| Full name | Center for Biologics Evaluation and Research | Center for Drug Evaluation and Research |
| Governing statute for its core products | PHS Act §351 (biological product license, BLA) | FD&C Act §505 (NDA/ANDA) for small molecules; PHS Act §351 (BLA) for the biologics it reviews |
| Vaccines | Yes — Office of Vaccines Research and Review | No |
| Blood and blood products for transfusion | Yes — Office of Blood Research and Review | No |
| Cell and gene therapies | Yes — Office of Therapeutic Products | No |
| Allergenic products | Yes — Office of Vaccines Research and Review | No |
| Plasma derivatives and clotting factors (recombinant and plasma-derived) | Yes — Office of Therapeutic Products | No |
| Small-molecule (chemically synthesized) drugs | No | Yes |
| Most therapeutic proteins and monoclonal antibodies | No (transferred out in 2003) | Yes — reviewed within disease-area offices, alongside small molecules for the same indication |
| Biosimilars | No | Yes |
| Generic drugs (ANDA) | No | Yes |
| OTC drugs | No | Yes |
| Internal organization | By product type (vaccines / blood / therapeutic products offices) | By disease area (Office of New Drugs’ oncology, infectious disease, neuroscience, etc. offices each cover both drugs and biologics) |
| What the 2020 BPCIA "deemed to be a license" event actually changed | Not applicable — CBER products were already BLAs | Reclassified certain NDA-approved protein drugs (e.g., insulin, human growth hormone) to BLA status on March 23, 2020; did not move review responsibility, since CDER already reviewed these products |
Common questions
Common questions about CBER vs CDER
Does CBER or CDER review monoclonal antibodies?
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CDER reviews most therapeutic monoclonal antibodies. Review of this category moved from CBER to CDER in 2003; it is not part of CBER’s current jurisdiction, which is built around vaccines, blood, allergenics, and cell/gene/tissue products.
Did biologics review move from CBER to CDER in 2020?
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Not in the way that phrase usually implies. The center-to-center transfer of most therapeutic biologics (monoclonal antibodies, therapeutic proteins, growth factors, immunomodulators) happened in 2003. What took effect on March 23, 2020 was the BPCI Act’s "deemed to be a license" provision, which reclassified certain NDA-approved protein drugs (insulin, human growth hormone, and others) as BLAs. For most of those products, CDER was already the reviewing center — 2020 changed the legal application type, not the center.
Which center reviews vaccines and blood products?
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CBER. Vaccines are reviewed by CBER’s Office of Vaccines Research and Review; blood and blood products for transfusion are reviewed by its Office of Blood Research and Review.
How does a sponsor find out which center will review a new product?
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For most products, precedent settles it — the reviewing center follows the pattern established for similar products, and a pre-IND meeting can confirm it informally. For a genuinely novel or combination product, a sponsor can file a Request for Designation (RFD) with FDA’s Office of Combination Products, which must issue a jurisdictional determination based on the product’s Primary Mode of Action within 60 days.
Are CDER-reviewed biologics still approved as BLAs?
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Yes. Being reviewed by CDER doesn’t change the licensing mechanism for products that meet the PHS Act §351(i) definition of a biological product — they’re still approved via BLA, just by a CDER review division rather than a CBER one.
Where do clotting factors sit?
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At CBER, in its Office of Therapeutic Products, which covers plasma derivatives and their recombinant analogues — clotting factors were a specific carve-out from the 2003 transfer and never moved to CDER.
Going deeper
