The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” ...
FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...
It’s a new year and decade – the perfect time to review your company’s documentation practices to limit your company’s potential civil and criminal exposure. Over the next few years, we expect FDA to ...