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

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

"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Clinical Trials ...

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...

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

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 ...

Elekta announced today that its Evo CT Linac received FDA 510(k) clearance, making it available to U.S. radiation oncology ...

FOLLOWING the identification of a potential safety and quality concern, the Food and Drug Administration (FDA) on Monday ...

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, ...

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 ...

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 Food and Drug Administration (FDA) on Friday said it has received at least 18 reports involving “health concerns” due to ...