Registering “Applicable Trial” Data on


Registering “Applicable Trial”
Data on
What Strategic Decisions
Do You Need to Consider?

Your office, June 9, 2014


Meet your instructor

Scott Cunningham is a partner within Covington & Burling’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.  Mr. 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.  Scott received his B.A. from the University of Pennsylvania and his J.D. cum laude from the University of Pennsylvania Law School.