About FDA

Office of New Drugs

Who We Are:

The Office of New Drugs (OND) ensures that safe and effective drugs and biologics are available to the American people. OND includes six offices with 19 review divisions. OND’s role is twofold: review applications and make an approval decision; set guidance and policy to ensure an efficient review process. OND reviews drug applications, interacts with the pharmaceutical industry and ultimately decides whether the benefits of a drug outweigh the known risks.

What We Do:

  • Provide regulatory oversight for investigational studies during drug development.
  • Make decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.
  • Provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
  • Communicate with the pharmaceutical industry to achieve the common goal of more efficient drug development.
  • Oversee the 21st Century Review initiative, which is a set of performance standards CDER follows when conducting drug reviews. The goal of this initiative is to make the drug review process organized and integrated, and ensure all decision makers are heard.
  • Update and maintain the Drugs@FDA database, which contains information about FDA-approved brand name and generic prescription and over-the-counter (OTC) human drugs and biological therapeutic products. The database includes most of the drug products approved since 1939.
  • Maintain and update information about current drug shortages, and answers frequently asked questions about drug shortages.
  • Maintain a searchable database of post-market studies and clinical trials for drugs and biological products.
  • Regulate OTC drugs.
  • Regulate drug labeling for human prescription drugs to ensure they contain essential scientific information needed for the safe and effective use of the drug.

Office Organization:

Contact Us:

OND Contact Information: This is a list of contacts and phone numbers for specific topics, including therapeutic areas.

E-mail: ondeio@fda.hhs.gov | Telephone: 301-796-0700 | Fax: 301-796-9856

Office of New Drugs, Immediate Office - Mail Stop 6311, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Related OND Resources

Provides quick links to databases and other relevant Web pages

Page Last Updated: 03/29/2018
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