The Office of New Drugs (OND) ensures that safe and effective drugs and biologics are available to the American people. OND includes eight review offices with 27 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 of New Drugs – Immediate Office
- Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) – Cardiology and Nephrology, Diabetes, Lipid Disorders, and Obesity, General Endocrinology, Nonmalignant Hematology
- Office of Immunology and Inflammation (OII) – Dermatology and Dentistry, Gastroenterology, Hepatology and Nutrition, Pulmonology, Allergy and Critical Care, Rheumatology and Transplant Medicine
- Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPRUM) – Pediatric and Maternal Health, Rare Diseases and Medical Genetics, Urology, Obstetrics and Gynecology
- Office of Infectious Diseases (OID) – anti-infective products; antiviral products, transplant and ophthalmology products.
- Office of Neuroscience – neurology products, psychiatric products, anesthesia, analgesia and addiction products
- Office of Nonprescription Drugs (ONPD) - nonprescription products (marketed under Over-the-counter (OTC) monographs and under NDAs).
- Office of Oncologic Diseases (OOD) - oncology products; non-malignant hematology products; issues related to hematology oncology toxicology.
- Office of Specialty Medicine (OSM) - drug products used in the image-based diagnosis and monitoring of diseases as well as ophthalmology products
E-mail: ONDCommunications@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
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 Oncologic Diseases (OOD)
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.
- Labeling Policy Team
- Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality