Expert Opinion

Litigation is an unfortunate fact of life for many life sciences companies as well as those who invest in such companies. Commercial disputes can arise with partners, collaborators, contractors, competitors, investors, and insurers. Oftentimes, such disputes hinge on a technical issue involving FDA laws and regulations.

Scott Lassman has experience working as an FDA legal expert on behalf of law firms representing litigants in commercial disputes. Scott has worked on a variety of cases, including patent infringement, “product hopping” (antitrust), securities litigation and insurance coverage. These cases raised FDA legal issues such as approval requirements and timing for Abbreviated New Drug Applications (ANDAs), approval of New Drug Applications (NDAs) under FDA’s Combination Rule, Good Clinical Practice (GCP) requirements, and Prescription Drug Marketing Act (PDMA) requirements. While not a large part of his practice, Scott will consider serving as a consulting or testifying expert for the right case.

You are invited to contact Lassman Law+Policy for more information on Scott's expertise and availability to serve as an FDA legal expert.

Scott Lassman

Scott M. Lassman's Profile Image
Scott Lassman has nearly 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice. He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them. His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters...

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