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 plants, Novartis said.   The warning, issued to Novartis’s generic drugs unit Sandoz on Oct. 22, came after FDA officials inspected its Turbhe and Kalwa […]

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 prevent the transmission of infections through the device. Duodenoscopes are flexible, lighted tubes inserted down the throat to drain fluids from blocked pancreatic and biliary […]

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 plant are adulterated. The health regulator in a letter dated Sept. 30 also warned that the company’s manufacturing, packing, storage and installation practices “are not […]

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 stimulant in its pure form. The drug regulator had in 2014 issued a consumer advisory warning of the risk to taking pure powdered form of […]

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 letters to the companies released on Monday. The letters, sent on Aug. 12, cite Olympus Corp Pentax Medical and Fujifilm Holdings Corp with multiple violations […]