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 ...

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, ...

FDA enforcement will focus on restricting GLP-1 APIs in mass-marketed, nonapproved compounded products to address unverifiable quality, safety, and efficacy under the FD&C Act. Appropriate compounding ...

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.

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 ...

The U.S. Food and Drug Administration has suspended its quality control program that tests dairy products, including milk. USA TODAY reports the agency’s Food Emergency Response Network Proficiency ...

Add Yahoo as a preferred source to see more of our stories on Google. The U.S. Food and Drug Administration has suspended its quality control program that tests milk and other dairy products. The Food ...

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 ...

When the U.S. Food and Drug Administration (FDA) finalized the Quality Management System Regulation (QMSR), it did more than modernize 21 CFR Part 820. The preamble explains that the rule primarily ...