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, ...

AI and digital tools are shifting quality oversight in the pharmaceutical industry from retrospective testing to real-time, ...

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 ...

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 ...

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.

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 ...

On April 21, The U.S. Food and Drug Administration (FDA) suspended its quality control program for testing milk and other diary products. The FDA has also suspended existing and developing programs ...

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 ...

WASHINGTON -- Staffing issues at the Food and Drug Administration have led to the suspension of a program that ensures the quality of milk and other dairy products. According to Reuters, the agency ...