Anne E. Johnson is the Program Division Director of the Office of Bioresearch Monitoring Operations, Division 1 within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She directs field inspectional operations covering FDA-regulated clinical and non-clinical research, post-marketing pharmacovigilance and select pre-approval programs designed to ensure human subject protection, evaluate data quality and integrity in product approval applications, and assess industry conformance with laws and regulations. Her division covers the eastern third of the United States, including Puerto Rico and the U.S. Virgin Islands.
She is also the District Director of FDA’s Philadelphia Office and the senior FDA representative and point of contact for the states of Pennsylvania and Delaware. In this capacity, she is responsible for liaison, emergency response and collaboration activities with other federal, state, and local agencies, while maintaining oversight for employee support and safety, and FDA facilities located within the district.
Ms. Johnson began with the FDA as an investigator and promoted to compliance officer, specializing in enforcement and regulatory follow-up in biologics, biotech drugs and biological device industries worldwide. She then became a supervisory investigator and district food monitor, advancing as Deputy District Director prior to her current positions.
Ms. Johnson is active on the speaking circuit, presenting at conferences for regulators, industry, academia, and stakeholders. She has researched and provided briefing and background information for use in preparation for congressional hearings and testimony, worked on national special security events, and overseen the execution of federal contracts. She chairs several committees and is an FDA trainer for managers and supervisors. She holds a B.A. in Chemistry, from Rutgers University.