U.S. FDA Office of New Drugs (OND) Organization, Functions, and Key Resources

1. Background and Mission

The Office of New Drugs (OND) within the FDA’s Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs and biologics are available to the American people. OND’s role is twofold: review applications and make approval decisions; 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. Source: https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs

2. Core Responsibilities

OND provides regulatory oversight for investigational studies during drug development, makes decisions on marketing approval for new (innovator or non-generic) drugs including changes to marketed products, provides guidance to industry on clinical, scientific, and regulatory matters, communicates with industry for efficient drug development, oversees the 21st Century Review initiative for organized drug reviews, updates and maintains the Drugs@FDA database (containing information on FDA-approved drugs since 1939), manages drug shortages information, maintains a searchable database of postmarket studies and clinical trials, regulates over-the-counter (OTC) drugs, and regulates prescription drug labeling to ensure essential scientific information for safe and effective use. Source: https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs

3. Organizational Structure

OND comprises an Immediate Office for overall oversight and eight specialized review offices with 27 review divisions focused on therapeutic areas:

• Immediate Office: Provides oversight for overall operations of OND.
• Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN): Includes divisions for Cardiology and Nephrology, Diabetes Lipid Disorders and Obesity, General Endocrinology, and Nonmalignant Hematology.
• Office of Drug Evaluation Sciences: Focuses on scientific evaluation support.
• Office of Immunology and Inflammation (OII): Includes divisions for Dermatology and Dentistry, Gastroenterology Hepatology and Nutrition, Pulmonology Allergy and Critical Care, and Rheumatology and Transplant Medicine.
• Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPRUM): Includes divisions for Pediatric and Maternal Health, Rare Diseases and Medical Genetics, Urology, and Obstetrics and Gynecology.
• Office of Infectious Diseases (OID): Handles anti-infective and antiviral products, pharmacology/toxicology for infectious diseases.
• Office of Neuroscience: Handles neurology, psychiatric, anesthesia, analgesia and addiction products.
• Office of Nonprescription Drugs (ONPD): Regulates nonprescription products under OTC monographs and NDAs.
• Office of Oncologic Diseases (OOD): Handles oncology and non-malignant hematology products.
• Office of Specialty Medicine (OSM): Handles image-based diagnostics, monitoring, and ophthalmology products.

Detailed division contacts are available in a PDF resource. Source: https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs

4. Key Resources and Databases

• Drugs@FDA Database: Information on FDA-approved brand name and generic prescription and OTC human drugs and biological products (most approved since 1939).
• Drug Shortages Database: Current shortages, reporting, resolved shortages, and FAQs.
• Postmarket Requirements and Commitments Database: Searchable database of post-approval studies and clinical trials.
• Additional resources include OND Annual Reports, Pediatric Product Development, Rare Diseases Program, and Labeling Policy information. Source: https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs

5. Contact Information

• Email: ONDExecOps@fda.hhs.gov
• Telephone: 301-796-0700
• Fax: 301-796-9856
• Mailing Address: Office of New Drugs, Immediate Office - Mail Stop 6311, 10903 New Hampshire Avenue, Silver Spring, MD 20993
• Full office and division contacts: Available as PDF. Source: https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs