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 (RWD) for regulatory decisions. This move aims to leverage patient-level data collected outside clinical studies to compare the efficacy and safety of interventions in clinical trials. Stakeholders have until the end of June to weigh in. What’s the Focus? The guidelines target sponsors planning to use RWD ECAs in trials needing…
AI as a medical device (AIaMD) in Europe is at a crossroads. As manufacturers grapple with compliance under two separate legal regimes – the EU AI Act (AIA) and EU Medical Device Regulations (MDR) – concerns are mounting around the sluggish pace of Notified Body designations and glaring inconsistencies between the two frameworks. Can the EU stay competitive when the AIA is piling on more regulatory obstacles than ever before? In our blog post, we…
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” for the stated purpose of ensuring that American patients will have access to the most-favored-nation (“MFN”) price for prescription drugs and biologics.1 This EO came out about one month after the release of EO No. 14273 titled “Lowering Drug Prices by Once Again Putting Americans First” (April 15, 2025) which outlined…
Following our previous post here, we provide an update on the current developments in this area. On April 2, 2025, the US administration announced reciprocal tariffs on all imports into the United States (see here). As it has been widely reported, pharmaceutical products were exempted from these tariffs whereas medical devices were not. Subsequently, on April 9, 2025, the administration announced a 90-day postponement of the reciprocal tariffs for most countries except for China. For…
