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Regulatory Focus interviews Janet Woodcock

  • 1.  Regulatory Focus interviews Janet Woodcock

    Posted 30-Jan-2024 09:03
    Wednesday, 30 January will be Janet Woodcock's final day at the FDA, capping a remarkable 38-year career at the agency.
    Regulatory Focus reporter @Joanne Eglovitch sat down with Woodcock to reflect on her beginnings at the agency, the crises that arose throughout her career, how she's dealt with a "cottage industry" of FDA critics and more. She also opened up about what she'd like to be remembered for and her plans for retirement.
    "Do you have any message to regulatory affairs professionals on how the field is evolving?" Joanne asked. "Do you have any thoughts on the evolution in the field of regulatory science?"
    Woodcock's response:
    "I would say to look for opportunities for simplification and streamlining and get behind those efforts. Get behind this ICMRA project on manufacturing supplements for example. I went and talked to many of the manufacturing quality people back in 2000s and I asked them 'what is your quality objective?' Some of them would say 'our objective is to pass the inspection' and I said 'that is not a quality objective.' Don't be reactive is my motto, figure out what the problems are and try to figure out solutions. Can this be simplified? Is this out of date? This is what I've done my whole career is trying to get things modernized and streamlined and use the best technologies and the best approaches."

    Ryan Connors
    Social Media and Communications Specialist