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.
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On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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