Michael Labson’s practice spans the full range of pharmaceutical, biologics and medical device regulation. He provides strategic advice in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area, and works actively on transactional and legislative matters.
Mr. Labson’s recent work has involved issues such as clinical trial conduct; breakthrough therapy designation and accelerated approval; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; product promotion; REMS; pharmacovigilance; drug samples; GMP and quality system requirements; FOIA; and Rx/OTC switches. He also has expertise on DEA and controlled substances issues, and child-resistant packaging requirements.
Mr. Labson is a member of the firm’s Management Committee, and previously was one of the firm’s Hiring Partners and co-chair of the Diversity Committee. He is also actively involved in pro bono work.