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Regulatory Focus™ > News Articles > FDA's Bob Temple Moving from ODE-1 to Other Position

FDA's Bob Temple Moving from ODE-1 to Other Position

Posted 31 January 2012 | By Alexander Gaffney, RAC 

Bob Temple, the US Food and Drug Administration's (FDA) Director of the Office of Drug Evaluation 1 (ODE-1), is fully assuming his role as Deputy Center Director for Clinical Science and giving up his role as the ODE-1 director, reports BioCentury.

Temple was first promoted to the position of Deputy Center Director in November 2009, but has remained in ODE-1. Prior to ODE-1, Temple worked in the Office of Medical Policy, which oversaw the then-named Division of Drug Advertising, Marketing and Communications (DDMAC). Temple has worked at FDA since 1972.

The current move is a result of Center for Drug Evaluation and Research Director Janet Woodcock asking Temple to devote more time to his job as Deputy Center Director for Clinical Science. He will reportedly still be involved in ODE-1 activities, which include the evaluation of neurology, renal, cardiovascular and psychiatry products.

Temple will be replaced by Ellis Unger, who currently serves as deputy director of ODE-1. Unger will serve as the Acting Director of ODE-1 until a full replacement is found.

Some industry watchers call Temple the "dean of drug development and drug review at FDA," and his departure from the division is seen as a significant development for the Office of Drug Evaluation.

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