Office of Drug Evaluation III (ODE III)
- Organizations within the Office
- Physician Request for a Single Patient IND for Compassionate or Emergency Use
- Investigator-Initiated Investigational New Drug (IND) Applications
- Meetings and Workshops
- Frequently Used Guidance Documents
- Drug Safety and Availability
Julie Beitz, M.D.
Director, Office of Drug Evaluation III
Amy Egan, M.D.
Deputy Director, Office of Drug Evaluation III
The Office of Drug Evaluation III is responsible for protecting the public health by assuring safe and effective drugs and biologics are available to the U.S. population for dermatology, dental, gastroenterology, reproductive, and urologic uses and for in-born-errors of metabolism and conditions involving bone metabolism.
The staff of ODEIII consists of over 130 highly trained physicians, scientists and regulatory project managers with expertise in gastroenterology, dermatology, dental, reproductive, urologic, nutrition, metabolism, pediatrics, internal 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.
ODEIII 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. There are three clinical divisions within ODEIII. The structure is as follows:
ODEIII Structure and Division Therapeutic Areas
|Division of Gastroenterology and Inborn Errors Products||Division of Dermatology and Dental Products||Division of Bone Reproductive and Urologic Products|
|Director: Donna Griebel, M.D.||Director: Susan Walker, M.D.||Director: Hylton V. Joffe, M.D., M.M.Sc.|
Gastrointestinal conditions and inborn errors of metabolism
|Dermatology and dental conditions||Reproductive and urologic conditions and conditions involving bone metabolism<|