Ranked in 3 Practice Areas
1

Band 1

1

Band 1

Life Sciences: Regulatory/Compliance

USA - Nationwide

7 Years Ranked

2

Band 2

Life Sciences

Massachusetts

1 Years Ranked

Ranked in Guides

About

Provided by Michael S Labson

USA

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

Provided by Chambers

Chambers Guide to the USA

Life Sciences: Regulatory/Compliance - USA - Nationwide

1
Band 1
Individual Editorial
Michael Labson counsels biotech and pharmaceutical clients on their compliance and relationships with the regulatory agencies.

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

1
Band 1
Individual Editorial
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.

Life Sciences - Massachusetts

2
Band 2
Individual Editorial

Michael Labson is an expert on FDA regulatory matters. He also regularly represents clients on transactional and commercial matters.

Strengths

Provided by Chambers

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