About FDA

Office of New Drugs

The Office of New Drugs (OND) is responsible for providing regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. We also provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.

Our Mission

  • To ensure that safe and effective drugs and biologics are available to the American people. 

Office Leadership

  • Janet Woodcock, M.D., Acting Director
  • Peter Stein, M.D., Deputy Director
  • Patrick Frey, M.P.P., Chief of Staff

Our Web page includes a number of tools to provide you with the most useful information in an easy-to-locate manner. 

  • Drug Development and Approval Process: Quick answers to a variety of commonly asked questions about regulation of the drug approval process. Here you will find additional resources such as guidance documents, laws and regulations, and general drug development information.
  • OND Contact Information (PDF - 41KB):  This is a list of contacts and phone numbers for specific topics, including therapeutic areas.

Realignment of the Office of Antimicrobial Products within the Office of New Drugs

We hope that our page will provide you with useful information about our organization and responsibilities. We welcome your feedback and suggestions. Please use the Contact Us box below to send us your questions or suggestions.

Related OND Resources

Provides quick links to databases and other relevant Web pages

Contact FDA

Office of New Drugs

Immediate Office - Mail Stop 6311

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 01/31/2017
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