Office of New Drug Review Divisions

U.S. Food and Drug Administration
Protecting and Promoting Your Health

Small Business Assistance
Center for Drug Evaluation and Research

Engaging with the FDA During New Drug Development

Paths of Contact to Engage with FDA

The Office of New Drugs (OND):

Provides regulatory oversight during drug development.
Makes decisions regarding marketing approval for new drugs.
Provides guidance to regulated industry on clinical, scientific, and regulatory matters.
OND is made up of six review offices (click the graphic for an enlarged PDF).

USER INSTRUCTIONS:

Click the picture of the OND Chart to enlarge it. Click NEXT to continue.

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