U.S. Food & Drug Administration: Draft Guidance for Industry and Other Interested Parties
Date: January 23, 2025
The U.S. Food and Drug Administration has issued its first guidance on the use of Artificial Intelligence (AI) for the development of drug and biological products.
This draft guidance, titled ‘Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products,’ has been put together to provide recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality.
