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- FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reformThe U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
- FDA updates guidance to clarify ANDA and 505(b)(2) approval pathwaysThe FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…