FDA Reorganization To Focus On Employee Specialization
This article was originally published in The Tan Sheet
FDA’s Program Alignment Group recommends “commodity-based and vertically-integrated programs” to improve efficiency and communication.
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Commissioner Margaret Hamburg awaits recommendations from a panel of senior agency officials on how to ensure FDA’s centers support Office of Regulatory Affairs’ activities without duplication.
FDA Commissioner Hamburg has appointed 10 officials to come up with a plan to realign the agency, with the goal of moving toward a “specialized program-based model.”
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.