Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for over 25 years. He draws on his wide range of regulatory expertise…
Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for over 25 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in litigation, investigations, and transactions.
Mike is the managing partner of the Boston office and co-chairs the firm's global Life Sciences practice. He previously served in a number of firm leadership positions, including as a member of the firm’s Management Committee and Executive Committee and as co-chair of the Diversity Committee.
Mike provides creative and practical solutions to biopharmaceutical clients large and small across critical regulatory areas. He actively advises on:
Clinical trial programs, including study subject recruitment, informed consent, good clinical practice conduct issues, and expanded access.
Regulatory approval strategies, including FDA expedited approval programs, FDA advisory committee preparation, and drug/device and drug/diagnostic approvals.
FDA dispute resolution.
Orphan drug, pediatric, and Hatch-Waxman exclusivity, and generic drug and biosimilar product approval standards.
Product promotion, payer, and scientific exchange communications.
Company post-approval activities, including REMS, pharmacovigilance, required post-marketing studies, and NDA and BLA changes.
Rx-to-OTC drug switches and OTC drug claims.
DEA requirements for controlled substances.
Mike’s pro bono work focuses on criminal justice matters. He is on the Board of the Children’s Law Center and previously served as the Vice Chair of the Children’s Dental Health Project. Mike has also been an Adjunct Professor of Law at the American University Washington College of Law, and is a Fellow of the American Bar Foundation.
Mike is Band 1 in Chambers Global and Chambers USA for Pharmaceutical/Medical Products Regulatory and Life Sciences Regulatory/Compliance. He is also recognized in The Best Lawyers in America, Washington DC Super Lawyers, and LMG Life Sciences, where he was the Life Sciences Attorney of the Year in 2016.
As one reviewer in Chambers stated, Mike is “a terrific regulatory lawyer and a good business counselor, who can explain things in ways that regular people can understand.”
Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for over 25 years. He draws on his wide range of regulatory expertise…
Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for over 25 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in litigation, investigations, and transactions.
Mike is the managing partner of the Boston office and co-chairs the firm's global Life Sciences practice. He previously served in a number of firm leadership positions, including as a member of the firm’s Management Committee and Executive Committee and as co-chair of the Diversity Committee.
Mike provides creative and practical solutions to biopharmaceutical clients large and small across critical regulatory areas. He actively advises on:
Clinical trial programs, including study subject recruitment, informed consent, good clinical practice conduct issues, and expanded access.
Regulatory approval strategies, including FDA expedited approval programs, FDA advisory committee preparation, and drug/device and drug/diagnostic approvals.
FDA dispute resolution.
Orphan drug, pediatric, and Hatch-Waxman exclusivity, and generic drug and biosimilar product approval standards.
Product promotion, payer, and scientific exchange communications.
Company post-approval activities, including REMS, pharmacovigilance, required post-marketing studies, and NDA and BLA changes.
Rx-to-OTC drug switches and OTC drug claims.
DEA requirements for controlled substances.
Mike’s pro bono work focuses on criminal justice matters. He is on the Board of the Children’s Law Center and previously served as the Vice Chair of the Children’s Dental Health Project. Mike has also been an Adjunct Professor of Law at the American University Washington College of Law, and is a Fellow of the American Bar Foundation.
Mike is Band 1 in Chambers Global and Chambers USA for Pharmaceutical/Medical Products Regulatory and Life Sciences Regulatory/Compliance. He is also recognized in The Best Lawyers in America, Washington DC Super Lawyers, and LMG Life Sciences, where he was the Life Sciences Attorney of the Year in 2016.
As one reviewer in Chambers stated, Mike is “a terrific regulatory lawyer and a good business counselor, who can explain things in ways that regular people can understand.”
