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.
- 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.
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
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.
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.