Ken Nolan

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FDA
Senior Advisor
As a Senior Advisor with the Stakeholder Engagement Staff located in the Office of External Affairs, Office of the Commissioner, Ken Nolan provides executive level policy and program direction for the U.S. Food and Drug Administration's (FDA) interactions, information exchanges and liaison activities to a variety of domestic and international trade associations to increase understanding of the agency's regulations, policies, and initiatives. This ensures that the agency’s most important scientific and regulatory issues are addressed through these outreach efforts by the appropriate agency spokespersons, resulting in a better understanding by industry of their manufacturing responsibilities regarding drug, biologic, device, food, tobacco, and veterinary medicine products. Represents the Office of External Affairs in meetings with other federal agencies, community groups and legislative staff in planning projects that involve FDA (such as the community-based planning project for the agency’s consolidation of staff at its White Oak facility). He has held a variety of positions since joining the agency, including being a Regulatory Project Manager managing a multi- disciplinary team of scientists (medical doctors, pharmacologists, nurses, experts in pharmacokinetics, chemists, pharmacists, mathematical statisticians, and general counselors) during the new drug application review process for adherence to all relevant FDA regulations, policies, and procedures promulgated through the Code of Federal Regulations. Prior to joining FDA, Mr. Nolan served as a Project Manager with a leading energy systems global corporation providing direct support to the Department of Energy Headquarters Environmental Management Program nuclear facilities and as a health physicist to nuclear facilities. Additional, experiences include performing as an emergency room and critical care technician in providing emergency, trauma, and critical care assistance to patients with acute illnesses or injuries. Mr. Nolan received a BA degree in Pre-Medicine Biology from University of Tennessee, Knoxville.