In a scathing rebuke (PDF) to AstraZeneca, the FDA cited “critical data quality issues that affect key analyses, including the primary endpoint” within a dataset for Saphnelo (anifrolumab) for the ...
1. FDA. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. FDA News Release. March 3, 2026.
Gottlieb was commissioner of the Food and Drug Administration from 2017 to 2019. When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife ...
This article originally appeared on ProPublica. It’s a fundamental tenet of health care in America: Generic drugs are just as safe and effective as brand-name ones. The only difference is the price.
Add Yahoo as a preferred source to see more of our stories on Google. The Food and Drug Administration has issued an order that bans Quality Poultry and Seafood from importing seafood, or any other ...
Recent articles have prompted questions about the quality of the nation's drug supply. Michael Kopcha, PhD, a registered pharmacist and the director of the Office of Pharmaceutical Quality at the FDA, ...
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The ...
NBC 5 Responds has confirmed the Food and Drug Administration has paused a program used for testing quality of fluid milk and other dairy programs. An internal email seen by Reuters said this was due ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...