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.
