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 The recently issued draft guidance on the Considerations for the Use of AI To Support Regulatory Decision-Making for Drug and Biological Products (FDA-2024-D-4689) is the FDA’s first attempt to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 will be evaluated in the
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