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Best Lawyers: Scott M. Lassman Recognized Again for FDA Law and Administrative/Regulatory Law

Scott M. Lassman recently was recognized again 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.

New, Emerging, and Continually Interesting Biologics Issues

Scott M. Lassman is scheduled to give 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 March 10, 2021.

Categories: Speaking

Lassman Law+Policy Submits Citizen Petition to FDA Regarding Vasopressin

On February 2, 2021, Lassman Law+Policy submitted a Citizen Petition to the Food and Drug Administration (FDA) on behalf of Amneal Pharmaceuticals LLC. The petition asks FDA to refuse to approve proposed dosing modifications for vasopressin based on patient genotype because they appear to be unnecessary, without adequate scientific support, and potentially unsafe for patients treated for vasodilatory shock. FDA has 180 days to respond to the Citizen Petition.

Categories: Other News

SCOTT M. LASSMAN NAMED IN WHO'S WHO LEGAL'S HEALTHCARE 2021 GUIDE

Scott M. Lassman recently was recognized as a leading regulatory attorney in the Who's Who Legal Healthcare 2021 guide.

The Who's Who Legal research process is based on recommendations and feedback from eminent private practitioners in the sector as well as from corporate counsel.

Categories: Honors

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

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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