FDA Psychiatry Division To Be Headed By Laughren Under Restructuring Plan
This article was originally published in The Pink Sheet Daily
Neuropharmacological reviewer Laughren will head FDA's psychiatric drug reviews after the division is spun off under the Office of New Drugs reorganization. Laughren's appointment is one of few top-level promotions under the restructuring effort.
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Russell Katz will retire following a 30-year career at FDA; his departure comes as the agency is embarking on new efforts to encourage drug development for Alzheimer’s disease and amyotrophic lateral sclerosis.
Harvey brings GI experience from the device center as former Gastroenterology & Renal Devices Branch reviewer. His appointment comes as FDA is eliminating the Office of Drug Evaluation V under the reorganization of the Office of New Drugs.
Neurology and psychiatry drugs would be reviewed in separate divisions under the proposed restructuring. The reorganization, which aims to group products by therapeutic indications and integrate the review of biologics and drugs, would eliminate ODE V.