Eric Colman, FDA’s Lead Obesity Drug Reviewer, Dies At Age 53

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and Keytruda’s expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.