- FDA releases draft guidance on evaluating drug behavior in patients with liver impairmentThe FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic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 considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearableThe Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…