Guide

What's CDER?

Brief rundown of the Center for Drug Evaluation and Research (CDER), the center that handles approvals and monitoring for new drug applications, generics, and more at FDA.

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Simplified org structure of FDA highlighting the CDER organization
Simplified org structure of FDA highlighting the CDER organization

The primary responsibility of the Food and Drug Administration (FDA) is to enforce the Federal Food Drug and Cosmetics Act (FD&C). FDA is a large organization, at the top level FDA is divided into 6 primary centers and numerous offices. Here I will briefly discuss CDER, one of the more visible and influential centers within FDA.

Abbreviated version of the FDA org chart, highlighting CDER.
Abbreviated version of the FDA org chart, highlighting CDER.

CDER’s Responsibilities

CDER is the Center for Drug Evaluation and Research. CDER’s stated mission is “to ensure that safe, effective and high-quality drugs are available to the public”. CDER’s regulatory responsibilities include1:

  • Prescription drugs
  • Generics
  • Over the counter drugs
  • Biosimilars (generic biologics)
  • Select therapeutic biologics

While most biologics23 (such as vaccines and gene therapies) are overseen by the Center for Biologics Evaluation and Research (CBER), in 2003 FDA transferred the responsibility for regulating some therapeutic biologics to CDER4, including:

  • Monoclonal antibodies
  • Therapeutic proteins (interferons, enzymes etc.)
  • Immunomodulators
  • Growth factors

All told, CDER’s operations and guidance touch nearly every aspect of the pharmaceutical and life sciences industry. To stay up to date on notices and guidance from CDER, bookmark the FDA TRACK page for CDER. You’ll get updates on post-drug surveillance, policy, safety reviews and more.

  1. See FDA’s page on CDER ↩︎

  2. Biologics are biological structures made to prevent, treat, or diagnose disease. Vaccines, blood products, and gene therapies are considered biologics. Biologic regulation and approval is handled by CBER at FDA ↩︎

  3. The NIH Stetten Museum has a history of Biologics Regulation and Research exhibit called The People and Work of Buildings 29 & 29A ↩︎

  4. FDA Jurisdiction Document (and archived) ↩︎

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