Foley Hoag presented an informative legal webinar that delves into the complexities of REMS (Risk Evaluation and Mitigation Strategies), a vital component of the FDA's drug safety program.
This comprehensive event explored the following key topics:
What is REMS?
- Gain insights into the FDA's drug safety program for specific approved medications.
- Identify the types of medications that warrant REMS due to serious safety concerns.
- Understand the distinction between REMS and adverse events, with a focus on the Product Label (prescribing information) versus REMS.
REMS and Patents
- Explore the intricacies of patent eligibility for REMS patents, including a case survey and §101 considerations.
- Delve into the listing of REMS patents in the Orange Book and the impact and strategy associated with Orange Book listings.
- Analyze the implications of the Jazz v. Avadel Federal Circuit ruling in February 2023, and its potential impact on REMS-patent listings.
A Look at the Regulatory and Legislative Landscape
- Examine the involvement of the Federal Trade Commission (FTC) and other amicus briefs in the Jazz case.
- Discuss legislative proposals related to REMS and their implications.
- Gain insights into the competing interests and agendas shaping the regulatory landscape.
This webinar is a must-watch for legal professionals, healthcare experts, and all those seeking a deeper understanding of REMS, its intersection with patents, and the evolving regulatory and legislative environment.
Download presentation materials here.
Please note that CLE credit is only valid for live attendance. At this time, we are not able to provide credit for recorded views. Please contact us for details.
