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Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
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This Week in FCPA-Episode 80, The Last Jedi Edition
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Compliance into the Weeds-Episode 39, Disclosure of Ransomware Attacks
In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more
Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more
We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more
Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House....more
In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more
Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more