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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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