2024 PDA/FDA Joint Regulatory Conference

Kenneth Nolan U.S. FDA

Kenneth Nolan

Kenneth Nolan U.S. FDA Senior Advisor

As a Senior Advisor within the Office of the External Relations, 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. As a representative of the Assistant Commissioner for External Relations, Mr. Nolan participates in meetings with other federal and local agencies, community groups, and congressional staff in planning projects that involve the Agency’s relocation to Silver Spring (White Oak), Maryland.

He has held a variety of positions since joining the agency, including being a Consumer Safety Officer 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.

Mr. Nolan received a BA degree in Pre-Medicine Biology from University of Tennessee, Knoxville.