Dr. Lee S. Simon

Biography

 Dr. Simon is a Rheumatologist and has been the Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (DAAODP) (2001-2003), within the Center for Drug Evaluation and Research (CDER), FDA.  He has been the recipient of several Quality Performance Awards and a Faculty Recognition Award from the FDA.  He has served on and has been the Acting Chair of the Arthritis Advisory Committee of the DAAODP (1993-2001). He has also served on the advisory committees for the Division of Over the Counter Drugs (1996), Center for Devices (1995), and for the Division of Hematologic and Gastroenterologic Drug Products (1996).  He has also served as a consultant for DDMAC (1993), the American Hospital Formulary (1990) and AMA Drug Products (1990).  He is presently a Principal in SDG LLC, a consulting firm helping companies to create successful drug development programs through good designs and using insightful regulatory strategy (2004-

Research Interest

 Healthcare