On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June 2017 entitled Use of Electronic
Scott Cunningham is a member of the firm’s Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies. Scott has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
Scott also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in neglect & abuse and child custody cases.