October 14, 2024
United States District Court in Florida Holds False Claims Act Qui Tam Provision Unconstitutional
October 10, 2024
United States District Court in Florida Holds False Claims Act Qui Tam Provision Unconstitutional
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
July 22, 2024
EU Artificial Intelligence Regulation Published - What You Need to Know
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
July 1, 2024
Loper Bright v. Raimondo
June 6, 2024
The Sky Is Not Falling – There's Time To Prep for Quality Management System Regulation's Launch
April 25, 2024
FDA Updates Draft Guidance on Promotional Labeling and Advertising Considerations for Biological Reference Products and Biosimilars
April 16, 2024
Podcast – Healthcare, Episode 5: Health Technology in the Age of AI: A Conversation with FDA Commissioner Robert Califf