Pharmaceutical Exclusivity: Navigating the Complex and Changing Rules – Webinar Recording/Transcript
Pharmaceutical Exclusivity: Navigating the Complex and Changing Rules
Get up to speed on the FDA exclusivity rules and critical developments.
Not knowing the latest developments could cause major delays in development, lose years of protection and cost your company millions of dollars.
Join us to get the latest on pharmaceutical exclusivity and how to navigate the complex changes.
- Familiarize yourself with the nuances of the new standard governing the scope of 3-year clinical investigation exclusivity and how that can affect FDA approval decisions, particularly 505(b)(2) applications
- Assess recent developments regarding orphan drug exclusivity, such as when exclusivity can be revoked and how FDA allows companies to evergreen it
- Critically evaluate the impacts of the upcoming March 23, 2020 transition of several important protein products, such as insulin, from being regulated as drugs to being regulated as biologics
- Get a sense of current legislative proposals aimed at exclusivity, including 180-day generic drug exclusivity, orphan drug exclusivity and other products
Get your product to market! Join us by registering today.
Meet Your Presenter:
Scott M. Lassman, Principal, Lassman Law+Policy
Your presentation leader, Scott M. Lassman, is the Principal at Lassman Law+Policy, a boutique law firm located in Washington, D.C., that focuses on solving its clients’ most complicated FDA-related problems. Scott 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.
Scott 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. Scott is author of the Exclusivity Rules blog, which focuses on the written and unwritten rules governing FDA’s exclusivity decisions.
Who Will Benefit:
- Brand pharmaceutical companies
- Generic pharmaceutical companies
- Brand biotech companies
- Biosimilar developers
- Quality, regulatory and compliance specialists
- Strategic planners