Scott Cunningham joined Covington & Burling in 2001 and 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 Cunningham 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. He 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.
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China’s National Development & Reform Commission (“NDRC”) announced this week that it has fined two domestic pharmaceutical companies for monopolizing bulk sales of promethazine hydrochloride in violation of the country’s Anti-Monopoly Law (“AML”). The decision, NDRC’s first AML action in the (...)
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