The Office of Immunology and Inflammation (OII) consists of six review divisions: The Division of Dermatology and Dentistry (DDD), the Division of Gastroenterology (DG), the Division of Hepatology and Nutrition (DHN), the Division of Pulmonology, Allergy and Critical Care (DPACC), the Division of Rheumatology and Transplant Medicine (DRTM), and the Division of Pharm-Tox for Immunology and Inflammation (DPT-II). The Immediate office oversees the development, review, and regulation of applications for drug and biologic products reviewed in these divisions.
The staff of OII consists of highly trained physicians, scientists and regulatory project managers with expertise in gastroenterology, dermatology, dental, hepatology and nutrition, metabolism, pulmonology, allergy and critical care, and rheumatology and transplant medicine, pharmacology/toxicology, and regulatory affairs. These professionals work with specialists in other CDER scientific disciplines such as statistics, clinical pharmacology, epidemiology, chemistry, and drug safety to collaboratively review data on new treatments.
OII is committed to facilitating rapid development, review, and action on promising new therapies. Scientists within the office are working intensively on incorporating innovations in pharmacogenomics, bioinformatics, and clinical trial design into the drug development process.
- Physician Request for a Single Patient IND for Compassionate or Emergency Use
- Investigator-Initiated Investigational New Drug (IND) Applications
- Meetings and Workshops
- Guidance Documents
- Drug Safety and Availability
Director: Julie Beitz, M.D.
Deputy Director: Victor Crentsil, M.D. (Acting)
Director of Project Management Staff: Renmeet Grewal, Pharm D, MS, RAC (Acting)
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Immunology and Inflammation
10903 New Hampshire Avenue, Silver Spring, MD 20993
Building 22, Suite 4177
Phone: (301) 796-2240
Fax: (301) 796-9838
Resources For You
- Office of New Drugs
- CDER Offices and Divisions
- Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality