Michael S Labson
About
Provided by Michael S Labson
Practice Areas
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 25 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 and business challenges.
Professional Memberships
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
Fellow, American Bar Foundation
Chambers Review
USA
Michael Labson counsels biotech and pharmaceutical clients on their compliance and relationships with the regulatory agencies.
Michael Labson is a preeminent regulatory expert with notable strength in advising on compliance and contentious FDA proceedings. He routinely handles transactions and investigations on behalf of prominent life sciences companies.
Strengths
Provided by Chambers
"The depth and breadth of Michael's expertise makes him standout."
"Michael can provide very technical regulatory advice but is also very practical in terms of assessing risk and being a good business partner."
"The depth and breadth of Michael's expertise makes him standout."
"Michael can provide very technical regulatory advice but is also very practical in terms of assessing risk and being a good business partner."
Discover other Lawyers at
Covington & Burling LLP
California
