Lexology July 25, 2023
Artificial intelligence tools present groundbreaking opportunities in the development of drugs and biologics and in manufacturing these medicinal products, with the potential for streamlining drug development and improving health outcomes through process optimization, advanced process controls and enhanced surveillance.
Rapidly evolving regulatory paradigms for AI
From innovative startups developing novel medicines and devices that integrate AI technologies to digital tech firms that are laser-focused on validating AI for the life sciences industry to global drug and device manufacturers whose strategic priorities include digital transformation, these technologies have the potential to unlock solutions to improved health outcomes and earlier access to essential medicines.
As stated by the U.S. Food and Drug Administration’s drug center director, Patrizia Cavazzoni, AI tools “are no...