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Artificial Intelligence: Industry Wants FDA To Boost Access To Databases, Clarify Use In Assessing Drug Efficacy

 
• By Brenda Sandburg

BIO, PhRMA, Genentech, Regeneron, AAM discuss transparency in use of AI, intellectual property protection, what constitutes AI, and its application in postmarketing safety surveillance.

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Biopharma industry answers US FDA's call for information on use of artificial intelligence in drug development • Source: Shutterstock

The biopharma industry told the US Food and Drug Administration what guidance is needed to advance the use of artificial intelligence and machine learning in drug development, from having regulatory clarity on AI/ML’s use in assessing efficacy to transparency considerations and the scope of FDA’s oversight.

More than two dozen stakeholders responded to a discussion paper the agency issued in May requesting input on the opportunities...

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