In Brief: CDER restructuring
This article was originally published in The Rose Sheet
Executive Summary
CDER restructuring: Office of OTC Drug Evaluation would be eliminated under a Center for Drug Evaluation & Research reorganization proposal announced April 4 by CDER Director Janet Woodcock, MD. The proposal would establish five new offices of drug evaluation. The OTC office would be incorporated into ODE 5, which also would have purview over new drugs that are potential Rx-to-OTC switches. ODE 5 would consist of three divisions -- OTCs, dermatologic and ophthalmic drugs, and anti-inflammatory/analgesic and dental drugs -- and would be headed by current Office of OTC Drug Evaluation Director Michael Weintraub, MD...