New, Emerging, and Continually Interesting Issues
Discuss emerging issues in transitional biologics, FDA protein definition, labeling carve-outs and carve-ins, authorized biosimilars, advertising and promotion draft guidance, purple book reform, and FDA’s umbrella policy for Reference Product (RP) exclusivity.
Scott M. Lassman, Principal, Lassman Law + Policy
This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in March 2022.
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SCOTT M. LASSMAN is the Principal at Lassman Law+Policy, a boutique law firm located in Washington, DC that focuses on solving its clients’ most complicated FDA-related problems. Mr. Lassman 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. Mr. Lassman also has extensive experience with the FDA Citizen Petition process and, when necessary, litigating FDA disputes in federal court. He has successfully protected his clients’ interests through litigation in a wide variety of matters, including Hatch-Waxman exclusivity, 180-day exclusivity, pediatric exclusivity, user fees, and approval requirements. Before starting Lassman Law+Policy, he was the Chair of the FDA Practice Group at a leading, international law firm, a partner at a well-regarded FDA boutique, and the head FDA regulatory attorney at a major pharmaceutical trade association.

























































































































