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- FDA releases draft guidance on evaluating drug behavior in patients with liver impairmentThe FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
- FDA urges validation of digital health endpoints and clear missing-data plansFDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…