Michael Labson provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area, and works actively on corporate transactions and government investigations.
Mr. Labson’s recent work has involved issues such as clinical trial misconduct; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; biosimilars; product promotion and scientific exchange; REMS; pharmacovigilance; Rx/OTC switches; and DEA regulation of controlled substances. Drawing on his 20+ years of experience working for the biopharmaceutical sector on a wide array of issues, he provides clients creative and practical solutions to solve their regulatory challenges.
Adjunct Professor of Law at the American University Washington College of Law
Children’s Dental Health Project, Vice Chair, Board of Directors (formerly)
Children’s Law Center, Board of Directors
Food and Drug Law Institute