Claire W. Dennis

Claire Dennis is a senior associate in the Life Sciences and Healthcare Regulatory practice at Arnold & Porter. She counsels FDA-regulated industry across the product life cycle with a focus on devices, drugs, biologics, and combination products. Her work regularly involves strategic thinking on medical product research & development, applications, and post-approval topics. 

Prior to joining Arnold & Porter, Claire was an Associate Chief Counsel at the U.S. Food & Drug Administration for nearly six years where she focused on medical devices, information disclosure, and combination products. At FDA, Claire was an integral member of the COVID-19 pandemic response and advised the agency and HHS on emergency use authorizations, enforcement, legislation, and questions concerning the Clinical Laboratory Improvements Act of 1988 (CLIA), the PREP Act, and the Defense Production Act. In addition, she provided counsel on draft and final guidance, proposed and final rulemaking, and worked on several priority topics, including in vitro diagnostics, clinical trial diversity, and emerging technologies.