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FDA Center for Drug Evaluation and Research (CDER)

As part of the US Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a consumer watchdog in America's healthcare system. CDER's best-known job is to evaluate new drugs before they can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely. The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.

Getting Started with CDER

Categories of Therapeutic Biological Products Transferred to CDER

Overview: Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)

  • Monoclonal antibodies for in vivo use.
  • Proteins intended for therapeutic use, including cytokines (e.g. interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to CBER (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, or microorganisms, and recombinant versions of these products.
  • Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or modifying a pre-existing immune response).
  • Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo.

Resources by Technology Category

The resources below are to connect entrepreneurs with a set of curated links available from the United States Food and Drug Administration (FDA) and contain links to resources that are relevant for early-stage companies developing oncology-related biological therapeutics.

Imaging Drug

I am working on an imaging drug – where can I get started?

Radiation Therapy

I am working on a radiation therapy – where can I get started?

Orphan Drug/Rare Disease

I am working on an orphan drug/rare disease – where can I get started?

Drug/Device Combination

I am working on a drug/device combination or drug delivery product – where can I get started?

Companion Diagnostic Device

I am working on a companion diagnostic device where - can I get started?

Small Molecule

I am working on a small molecule product - where can I get started?

Biologic Antibody

I am working on a biologic antibody product - where can I get started?

Premarket Submission Resources

What is the right premarket submission for my technology?

New Drug Application (NDA) Resources

Biologic License Application (BLA) Resources

Expedited Review Programs

Pre-Clinical Resources

Investigational New Drug (IND) Resources

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