Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health Care

The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it. Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs. Over the past year, Mary and her team at the GAO have published two FDA-specific reports: Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight: https://www.gao.gov/products/gao-20-594 Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog: https://www.gao.gov/products/gao-21-409t Need expert help preparing for a potential increase in FDA inspection and enforcement activity? Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started: www.thefdagroup.com.