On International Clinical Trials Day, the UK’s MHRA unveiled a major shift: a consultation on using external control arms (ECAs) based on real-world data…
AI as a medical device (AIaMD) in Europe is at a crossroads. As manufacturers grapple with compliance under two separate legal regimes – the…
On May 12, 2025, the White House issued a wide-reaching Executive Order (“EO”) titled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients”…