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 ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, address data integrity within the context of revised or new parts of the ...
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 ...
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