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FDA fast-tracking approval of new drugs — fewer trials, less info

The Food and Drug Administration is approving new drugs after just one or two clinical trials, a significant departure from earlier, more rigorous approval processes. ....

Veronica Irvin , Nina Zeldes , Health Affairs Scholar , Drug Administration , Oregon State University College Of Health , Oregon State University , Century Cures Act , Public Citizen , Health Care , Prescription Drugs ,

FDA approved Rexulti to be the first antipsychotic for treating agitation in elderly patients with dementia

In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia. ....

United States , Rajesh Narendran , Nina Zeldes , Lon Schneider , Robert Whitaker , Oderick Turner , Danielle Ellis , Alliance For Aging Research , Drug Administration , Us Centers For Medicare , Medicaid Services , Leaders Engage On Alzheimer Research , Advisory Committee , Oregon Health Science University , Keck School , Southern California , Drug Evaluation , Aging Research , Leaders Engage , Oregon Health , Science University ,

Alarm as FDA fast-tracks first antipsychotic drug for agitation in dementia

Alarm as FDA fast-tracks first antipsychotic drug for agitation in dementia
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