Day: August 18, 2024

A couple of weeks back I speculated if we need an independent oversight of the FDA to rein in the seemingly unaccountable power its leadership holds over the industry it regulates. The same week, the US Supreme Court reversed a decades-old legal doctrine that gave government agencies, like the FDA, such power. There are divergent … Read more

While there have been numerous discussions by regulators worldwide, particularly the FDA and European Medicines Agency (EMA), about the regulation of devices based on Artificial Intelligence (AI), there have not been any specific rules, till this week. The EU published the first formal regulation for AI this week to lay down a uniform legal framework … Read more