Office of Drug Evaluation III (ODE III)

Mission

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.

Immediate Office

Director: Julie Beitz, M.D.
Deputy Director: Vacant

Associate Director For Regulatory Affairs: Maria R. Walsh, R.N., M.S.
Regulatory Scientist: Giuseppe Randazzo, M.S.
Program Support Specialist: Diane Thomas

Divisions

• Division of Dermatology and Dental Products
• Division of Gastroenterology and Inborn Errors Products
• Division of Reproductive and Urologic Products

 

Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Drug Evaluation III
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2100
Fax: (301) 796-9906