The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court. 

The U.S. Food and Drug Administration is warning consumers who seek to buy medications through websites that they may be opening themselves up to of a swarm of imposters claiming to be representatives of the regulatory agency.

The U.S. Food and Drug Administration issued a warning letter to Meridian Bioscience Inc.’s unit for several federal law violations after inspecting its facility that makes lead-testing devices.

A U.S. regulator told Pfizer Inc.’s Meridian Medical Technologies division, maker of the EpiPen injector device, that serious component and product failures have been associated with patient deaths and severe illness.

The U.S. Food and Drug Administration warned Novartis AG last week after the Swiss firm was found in violation of manufacturing practices last year at two of its India drug-making […]

The U.S. Food and Drug Administration has ordered three Japanese manufacturers of duodenoscopes to conduct studies to evaluate how the devices are being used, as part of its effort to […]

Heart device maker St. Jude Medical Inc received a warning letter from the U.S. Food and Drug Administration, which said that various devices of the company manufactured at its Atlanta […]

The U.S. Food and Drug Administration on Tuesday issued warning letters to five distributors of pure powdered caffeine, as the federal agency stepped up efforts to curtail ingestion of the […]

Manufacturers of medical devices linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration said in warning […]