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U.S. Department of Health and Human Services

About FDA

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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

  • John Jenkins, M.D., Director
  • RADM Sandra Kweder, M.D., Deputy Director

 

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.

 

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Related OND Resources

Provides quick links to databases and other relevant Web pages

  • Drugs@FDA Database
    Provides information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939.
  • Drug Application and Approval Process - "Questions and Answers"
    Frequently asked questions and answers about the drug application and approval process. Submit a question and your question, with the answer, may be added to this list.
  • Drug Shortages
    Includes information on current drug shortages, how to report drug shortages, resolved drug shortages, drugs to be discontinued, and answers to frequently asked questions about drug shortages.
  • Office of Hematology and Oncology Products (OHOP)
    Includes information about OODP, which regulates drug and therapeutic biologic treatments for cancer.
  • Pediatric Product Development
    Includes information about FDA initiatives related to improving medical product research in children.
  • Postmarket Requirements and Commitments
    Includes a searchable database of information on postmarket studies and clinical trials for drugs and biological products.
  • Rare Diseases Program
  • Regulation of Nonprescription Products
    Includes information about the Office of Drug Evaluation IV, which regulates over-the counter (OTC) drugs. OTC drug products are those drugs that are available to consumers without a prescription.
  • Study Endpoints and Labeling Development
    Includes information about Clinical Outcome Assessments (COAs) to measure efficacy endpoints and information about the Physician Labeling Rule (PLR) and other labeling resources.
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Contact FDA

301-796-0700
Fax:301-796-9856
Office of New Drugs

Immediate Office - Mail Stop 6311

10903 New Hampshire Avenue

Silver Spring, MD 20993