A closer look at CDER’s new 2024 guidance agenda


The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. AgencyIQ analyzed the document to determine which documents were new, which had been carried over from the last edition of the agenda, and which documents had been removed. Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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