Dose Ranging Study In Phase III Could Bolster Rx Safety Profile, Temple Says
Executive Summary
Evaluating a range of doses in Phase III clinical trials could bolster the safety profile for an investigational new agent, FDA Office of Medical Policy Director Robert Temple, MD, said April 9
You may also be interested in...
Clinical Trials Should Include Finding Maintenance Dose, FDA’s Temple Says
Maintenance doses are not sufficiently studied in clinical trials, FDA Center for Drug Evaluation & Research Medical Policy Director Robert Temple, MD, said
Clinical Trials Should Include Finding Maintenance Dose, FDA’s Temple Says
Maintenance doses are not sufficiently studied in clinical trials, FDA Center for Drug Evaluation & Research Medical Policy Director Robert Temple, MD, said
Approval Delays For Standard NMEs Caused Primarily By “Safety Issues” – FDA
FDA is citing "safety issues" as the primary reason for approval delays for standard new molecular entities in 2000 and 2001 in its 12002 Report to the Nation