U.S. Food and Drug Administration News

New York County Sues Purdue, J&J Over Opioid Marketing

A county in New York state has sued Purdue Pharma LP, Johnson & Johnson and other drugmakers, accusing them of engaging in fraudulent marketing that played down the risks of prescription opioid painkillers, leading to a drug epidemic. The lawsuit, …

Alabama Seafood Company to Halt Fish Processing Due to Unsanitary Conditions

Federal court officials say an Alabama seafood company has agreed to stop processing fish after complaints were raised by the U.S. Food and Drug Administration. U.S. District Court officials said in a statement July 7 that the permanent injunction is …

FDA Extends Required Warnings to Short-Acting Opioid Painkillers

Short-acting opioid painkillers will carry strong new warnings under U.S. Food and Drug Administration requirements announced on Tuesday that will bring information about addiction and abuse in line with that on long-acting pills. The FDA’s action comes a week after …

New ‘Superbug’ Linked to Scope Found at California Hospital

A Los Angeles-area hospital said that some of its patients contracted an antibiotic-resistant “superbug” that has been linked to a type of medical scope and infected dozens of people around the country. Huntington Memorial Hospital said in a statement Wednesday …

California Company Among Those to Recall Frozen Spinach

Three organic food companies that use spinach in their food have recalled hundreds of thousands of items over listeria concerns. Organic food company Amy’s Kitchen, in Petaluma, Calif., has voluntarily recalled about 74,000 cases of frozen and prepackaged products containing …

California “Superbug” Outbreak Prompts FDA Alert on Device

The complex design of endoscopes that have been linked to a “superbug” outbreak at the UCLA Health System in California may hinder proper cleaning, the U.S. Food and Drug Administration warned on Thursday. The hospital system said seven patients were …

ACE Westchester Extends Its Product Recall Insurance to Small Businesses

ACE Westchester has launched ACE Recall Plus for Small Business, a product that offers product recall coverage and crisis management services to the small business market segment. The move follows an increase in the frequency and cost of product recalls …

New Food Safety Rules Delayed to Weigh Farmers’ Concerns: FDA

Food safety rules the U.S. planned to implement this year are being delayed by months because the requirements were too complex for some farmers, regulators said. Two core rules of the Food Safety Modernization Act of 2011 that were proposed …

Food Borne Illness Cases Present Complex Coverage Questions

One of the most heavily litigated insurance issues in coverage liability cases related to outbreaks of widespread food borne illnesses is the determination of occurrence where multiple people in multiple states are affected by a contaminant that seems to stem …

FDA Plans IDs to Track Medical Device Safety

Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters. The U.S. Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code …