IP implications of the FDA guidance for use of AI in drug development
http://ipkitten.blogspot.com/2025/06/ip-implications-of-fda-guidance-for-use.html The intersection of AI and pharmaceutical regulation is rapidly evolving, with potential implications for IP strategy. The recently issued draft guidance on the Considerations for the Use of AI To Support Regulatory Decision-Making for Drug and Biological Products (FDA-2024-D-4689) is the FDA’s first attempt to standardize how AI-generated data and models... Continue reading