December 19, 2023
The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights
August 24, 2023
FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials
March 27, 2023
With Risk Comes Responsibility: EU Proposes High-Risk AI Regulation Affecting Device Manufacturers
March 7, 2023
FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug
January 23, 2023
2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance