FDAAA Leadership

Betty L. Jones, Ph.D., MPH

Betty L. Jones, Ph.D., MPH

Betty L. Jones is currently Managing Director at Comprehensive Compliance Solutions, LLC, a consulting firm specializing in offering a broad spectrum of support and regulatory assistance to firms that manufacture and market biological products, cosmetics, devices and human and veterinary drugs regulated by the Food and Drug Administration (FDA). CCS brings together an inter-disciplinary team of former FDA executive level officials and decision makers with expertise in regulatory compliance, quality systems, regulatory submissions, process and equipment validation, audit inspections, risk management and training.

Dr. Jones has 34 years of experience with the Food and Drug Administration directing regulatory and compliance activities of human and veterinary pharmaceuticals, biologics, devices and foods in three of FDA's six components with multi-district and multi-center experiences. She has experience as a field investigator and inspector, a field and headquarters compliance officer, a regulatory compliance specialist, a project manager, a branch chief, Deputy Director and Acting Office Director.

As the Deputy Director/Acting Director, Office of Compliance in Center for Drug Evaluation and Research (CDER), she provided leadership in administering thirty-five nation-wide human drug programs, enforcement policy development, regulatory strategic planning, risk-management strategies and results and program management. She managed and directed a multi-disciplinary staff of one hundred sixty regulatory and scientific personnel engaged in enforcement of compliance programs designed to protect consumers from unsafe or ineffective medical products and promoting and protecting public health. Dr. Jones had executive responsibility for program management and enforcement of drug manufacturing and product quality, cGMPs, prescription and OTC drug labeling and marketing, new drugs, internet sales and promotion, import and export issues, drug recalls and product surveillance.

As Chief of the Regulatory Management Branch, she was responsible for the regulatory activities of the CDER's bioresearch monitoring of preclinical and clinical drugs, institutional review boards, sponsor monitors, adverse drug experiences and narcotic treatment programs.

Dr. Jones has extensive experience as a field consumer safety officer where she conducted inspections and investigations of food, biologic, device, drug (human and veterinary) and cosmetic establishments for current good manufacturing practices.

She holds a B.S. degree in biology, a M.S. and Doctorate in public health graduating magna cum laude. Dr. Jones is the recipient of numerous Department, Agency and Center awards and is an alumna of FDA's Leadership Development Program, the Federal Executive Institute, OPM Executive Leadership Development Program and Harvard University.