Fourth Circuit Weighs in on Public Disclosure Bar and Retroactivity
Client Alert | 1 min read | 12.13.13
The Fourth Circuit in U.S. ex rel. Radcliffe v. Purdue Pharma.(Dec. 12, 2013) became the first court of appeals to address whether the FCA's public disclosure bar is still jurisdictional after its 2010 amendment by the Affordable Care Act (a topic about which Crowell & Moring attorneys wrote articles in March and September) and held that it is not, reasoning that the word jurisdiction was excised from the statute and that the government was newly empowered to veto application of the bar. This decision came in the context of a broader analysis in which the court clarified that the date of the allegedly fraudulent conduct, not the date that the complaint was filed, governs potential retroactive effect.
Insights
Client Alert | 6 min read | 05.11.26
FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road
Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories: (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria.
Client Alert | 4 min read | 05.11.26
New Temporary State Aid Framework Throws A Lifeline To Sectors Hit By The Middle East Crisis
Client Alert | 4 min read | 05.11.26
Client Alert | 6 min read | 05.08.26
