News

Scott M. Lassman Speaks at AAM's GRx+Biosims 2020 Conference

On November 11, 2020, Scott M. Lassman participated in a panel discussion on "Marketing and Launching Complex Generic Drugs Under Regulatory Uncertainty" at the Association for Accessible Medicine's (AAM's) GRx+Biosims 2020 conference. The panel addressed a number of areas of uncertainty, including Q1/Q2 sameness requirements, Product Specific Guidances (PSGs), and exclusivity.

Categories: Speaking

Best Law Firms: Lassman Law+Policy Recognized for FDA Law and Administrative/Regulatory Law

Lassman Law+Policy was recognized by U.S. News & World Report as one of the Best Law Firms in Washington, D.C. in the areas of FDA Law and Administrative/Regulatory Law for 2020. This is the first time the firm has been recognized on this prestigious list.

Categories: Honors

Scott M. Lassman Speaks at FDLI Advertising and Promotion Conference

Scott M. Lassman participated in a panel discussion on October 28, 2020 regarding "FDA-FTC Biologics Promotion Enforcement" at the Food and Drug Law Institute's (FDLI) Advertising and Promotion for Medical Products Conference. Scott's presentation focused on the promotional implications of a recent patent infringement case, GlaxoSmithKline v. Teva, on biosimilars and interchangeable biologics.

Categories: Speaking

NEW, EMERGING AND CONTINUALLY INTERESTING BIOSIMILARS ISSUES

Scott M. Lassman gave a presentation on New, Emerging, and Continually Interesting Issues at the Food and Drug Law Institute's Introduction to Biologics and Biosimilars Law and Regulation conference on October 15, 2020.

Categories: Speaking

Scott M. Lassman Speaks at FDLI's Annual Conference 2020

Scott M. Lassman participated in a panel discussion at FDLI's Annual Conference 2020 on October 6, 2020 regarding "Issues and Topics in Litigation Challenging FDA Actions under the Administrative Procedure Act (APA)." Scott's presentation focused on the evolving risks and benefits of challenging FDA actions on Chevron Step Two grounds.

Categories: Speaking

LMG Life Sciences: Scott M. Lassman Recognized as a Regulatory Law Star for 2020

Scott M. Lassman recently was recognized by LMG Life Sciences as a Regulatory Law Star in the areas of pharmaceutical and medical device regulatory law for 2020.

LMG Life Sciences evaluates attorneys on the basis of case evidence, peer feedback and client feedback.

Categories: Honors

RAPS Convergence 2020 Session on the "Regulatory Strategy of Drug Competition"

Scott M. Lassman is scheduled to speak on September 16, 2020 at RAPS Convergence 2020 on a panel entitled The Regulatory Strategy of Drug Competition.

Categories: Speaking

Best Lawyers: Scott M. Lassman recognized for FDA and Administrative Law

Scott M. Lassman recently was recognized by The Best Lawyers in America as one of the leading lawyers in America in the categories of FDA Law and Administrative/Regulatory Law.

Best Lawyers' recognitions are based purely on the feedback received from lawyers already highlighted in the publication.

Categories: Honors

FDLI's "Law Over Lunch" Program

On July 30, 2020, Scott M. Lassman served as the facilitator for a session on "Orphan Drugs: Interesting Cases and New Developments" at FDLI's popular Law Over Lunch series.

WCL's Hot Topics in Drug and Medical Device Regulation

Scott M. Lassman will be participating in a panel discussion on June 19, 2020 on Hot Topics in Drug and Medical Device Regulation, which is part of Washington College of Law's Virtual Summer Series on Health Law and Policy (co-sponsored by the American Health Law Association). He will be presenting on new developments regarding orphan drug exclusivity.

Categories: Speaking

Scott Lassman

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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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