Food and Drug Administration News

Costco Recalls Frozen Berries Linked To Hepatitis Outbreak

The Food and Drug Administration is investigating an outbreak of hepatitis A linked to a frozen organic berry mix sold by an Oregon company. The FDA and the federal Centers for Disease Control and Prevention said Friday that 30 illnesses …

FDA Finds Safety Issues at Specialty Pharmacies

The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs. The agency said its inspectors targeted 31 compounding …

FDA Seeks Feedback on New Food Safety Regulations

The U.S. Food and Drug Administration kicked off a series of public meetings on Thursday to explain its proposed new rules for improving the safety of the nation’s food supply – and gain feedback on the potential regulations. The rules …

FDA Proposes New Food Safety Rules

U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually. The new rules, required by the Food Safety Modernization …

Meningitis Outbreak Spurs Calls to Boost Pharmacy Oversight

U.S. and state health regulators called on Congress on Tuesday to strengthen federal oversight of compounding pharmacies as lawmakers prepared for two days of hearings on a deadly fungal meningitis outbreak linked to a compounded steroid. But the main federal …

FDA Investigating 5 Deaths for Possible Tie to Monster Energy Drink

The U.S. Food and Drug Administration said on Monday that it is investigating reports of five deaths that may be associated with Monster Beverage Corp.’s namesake energy drink, and the company’s shares fell more than 14 percent. Monster is also …

U.S. Drug Recalls Common But Not Well-Publicized: Study

The U.S. Food and Drug Administration recalls potentially harmful drugs about once every month but could do a better job of letting doctors and patients know about them, according to a study released on Monday. Over an eight-year span, researchers …

Regulators Urged to Monitor Safety Throughout Drug’s Lifecycle

The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body. The …

U.S., Europe Urged to Offer Product Safety Training to Importers

Food and drug regulators in the U.S., Europe and other developed countries should offer training, technology and expertise to developing nations in Asia, Latin America and other regions to better assure the safety of imported products, states a new report. …

PIP Breast Implant Scandal Exposes Weaknesses in EU Safety Net

In June 2000, when American medical regulators posted a warning letter on the Internet about problems at a breast-implant maker in southern France, French authorities didn’t pay much attention. A U.S. Food and Drug Administration (FDA) inspection had found some …