On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June 2017 entitled Use of Electronic
Emily Statham
Emily Statham is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and Life Sciences Transactions Practice Groups. She advises pharmaceutical, biotechnology, and medical device companies on a variety of regulatory, compliance, and transactional issues.