HMO Claims Study Will Provide Next Data For Antidepressant Safety Review
Executive Summary
A 24,000-patient pediatric safety study currently under peer review could provide the next pool of data on the relationship between antidepressants and suicidality
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The quality of pediatric research on antidepressants may have been affected by the need for manufacturers to complete trials in time to receive exclusivity extensions, FDA Office of Drug Evaluation I Acting Director Robert Temple, MD, suggested during the Sept. 13-14 advisory committee review of antidepressant safety
Pediatric Exclusivity Incentive May Encourage Sloppy Trials, FDA Says
The quality of pediatric research on antidepressants may have been affected by the need for manufacturers to complete trials in time to receive exclusivity extensions, FDA Office of Drug Evaluation I Acting Director Robert Temple, MD, suggested during the Sept. 13-14 advisory committee review of antidepressant safety
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