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Critical Issues in Hatch-Waxman Litigation
The pharmaceutical labeling carve-out regulations remain a source of complexity in several cases. The Hatch-Waxman Act created a way for the Food and Drug Administration (FDA) to approve generic drugs even if they omit information about protected use to encourage competition among generic products. However, following the Teva v. GSK ruling, businesses must exercise caution and recognize the intricate relationship between Orange Book listed use patents, reference listed drug’s prescribing information, and promotional labeling and other related activities.
The U.S. Offshore Wind Energy: Regulatory Developments and Compliance Issues
In this LIVE Webcast, a panel of thought leaders and professionals brought together by The Knowledge Group will provide and present an in-depth analysis of the fundamentals as well as recent developments in Accounts Payable Automation: Business Cost-Control Strategies Explored. Speakers will also present all important issues surrounding this significant topic. Join us for this Knowledge Group Webinar!
Significant Class Action Trends and Developments
Over the years, the number of class action lawsuits has significantly grown in both federal and state courts. As regulatory developments continue to emerge and impact litigation practices, practitioners are confronted with significant challenges. Hence, they must keep themselves abreast of any development in this field of law. Likewise, implementing a sound class action strategy is critical to dodge any litigation pitfall.
IT Strategies for Early-Stage Biotech & Pharma
Early-stage life sciences organizations face many challenges, but planning and implementing IT doesn’t have to be one of them.
The Future of International Arbitration: What to Expect in 2024 and Beyond
In the ever-evolving landscape of international dispute resolution, the future unfolds with a tapestry of possibilities, challenges, and innovations. As we stand on the cusp of 2024 and peer into the horizon beyond, the realm of international arbitration takes center stage
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