Offices of Drug Evaluation

Guidelinesfor Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, Office of Drug Evaluation and Research (HFD-100), FDA, RockviUe, Md., 1987, pp. 3, 4. 

Murphy, Diane, M.D., Director, Office of Drug Evaluation fV, ODER, March 28, 2001. 

Spurred on by Laughren s (1991) critique, an exchange of memos occurred between Paul Leber and his boss, Robert Temple, Director, Office of Drug Evaluation 1. The continuing subject was the approval of Zoloft, whose efficacy as an antidepressant remained in doubt up to the last minute. Temple noted that Zoloft was not being approved in some European countries because of its lack of robustness in the efficacy trials. Zoloft often failed to do any better than placebo in studies in the United States and never did as well as the older antidepressant amitriptyline. Despite these pervasive failures, one positive study and two supportive studies were found sufficient to earn approval. 

Food and Drug Administration Office of Drug Evaluation and Review Central Document Room Park Building, Room 214 12420 Parklawn Drive Rockville, MD 20852... 

FDA s Office of Drug Evaluation IV have collaborated in drawing up a Targeted Product Information template (23). 

Guideline for Drug Master Files, Center for Drug Evaluation and Research, Food and Drug Administration, Department of Flealth and Fluman Services, Office of Drug Evaluation I (FIFD-100), 5600 Fishers Lane, Rockville, Maryland 20857, September 1989. 

Office of Drug Evaluation (CDER now has five such offices ODE I, II, III, IV, and V)... 

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