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- FDA signals upcoming rules for generative AI use in drug developmentThe FDA announced it intends to create regulatory guidance for the use of generative artificial intelligence in pharmaceutical research and development. The move follows growing interest in AI too…
- FDA finalizes guidance on therapeutic equivalence evaluations for ANDAsThe U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…