1. In Vivo

Digital Transformation At The FDA: Generative AI Set To Transform Drug Review Process

 
• By David Wild

The FDA plans to implement generative AI for drug reviews by 30 June 2025, enhancing efficiency and potentially accelerating approval processes. Discussions with OpenAI about AI integration are ongoing.

Bio Bytes
• Source: Shutterstock

In a development that could fundamentally alter the drug approval landscape, the US Food and Drug Administration has completed its first successful implementation of generative AI for scientific reviews and announced plans for agencywide deployment by 30 June 2025.

The generative AI system for regulatory reviews has demonstrated remarkable efficiency, with the FDA saying in a press release that...

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