The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” for using artificial intelligence (AI) in drug ...
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 ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...