The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...

The FDA orders the recall of a nasal spray in the US after finding live microbes; immunocompromised patients are at greatest ...

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 ...

The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...

M4Q (R2) is a globally harmonized framework for structuring quality information in medicinal product registration ...

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.

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 ...

Generic drugs account for more than 90 percent of prescriptions filled in the United States. Recent studies have found concering variability in quality and safety America’s generic drug supply, most ...

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 ...