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.
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 is scheduled to speak on September 16, 2020 at RAPS Convergence 2020 on a panel entitled The Regulatory Strategy of Drug Competition.
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.
Scott M. Lassman is scheduled to speak about New, Emerging, and Continually Interesting Issues at the Food and Drug Law Institute's Introduction to Biologics and Biosimilars Law and Regulation conference on April 1, 2020.
On February 27, 2020, Scott M. Lassman presented a webinar on recent developments affecting exclusivity for drugs and biological products. The webinar was hosted by FDANews.
Scott M. Lassman participated in a panel discussion entitled Biosimilars at the Bar at AAM's GRx+Biosims Conference on November 4, 2019. The panel discussed recent legal developments affecting biosimilars, including interchangeability, labeling carve-outs, enhancements to the Purple Book and regulatory pathways for approval of "biobetters."
Scott M. Lassman is scheduled to speak about New, Emerging, and Continually Interesting Issues at the Food and Drug Law Institute's Introduction to Biologics and Biosimilars Law and Regulation on October 2, 2019 in Washington, D.C.
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