U.S. Food and Drug Administration News

US FDA, CDC Investigating Multi-State Listeria Outbreak

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said on Monday the agencies were investigating a multi-state outbreak of listeria infections linked to frozen supplemental shakes manufactured by Prairie Farms Dairy Inc. As of …

J&J Sues Samsung Bioepis Over Contract Breach for Stelara Biosimilar

Johnson & Johnson said on Monday it had filed a lawsuit against Samsung Bioepis for breaching its contract agreement with the drugmaker over the launch of a biosimilar to Stelara, J&J’s autoimmune drug. J&J said it is seeking a preliminary …

US FDA Identifies Cybersecurity Risks in Certain Patient Monitors

The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with certain patient monitors from Contec and Epsimed and urged healthcare facilities to mitigate those risks. Patient monitors, used in both healthcare facilities …

US FDA Identifies Cybersecurity Risks in Certain Patient Monitors

The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with certain patient monitors from Contec and Epsimed and urged healthcare facilities to mitigate those risks. Patient monitors, used in both healthcare facilities …

Tornado Damage to Pfizer Plant Unlikely to Cause Major Drug Supply Shortages, FDA says

RALEIGH, N.C. (AP) — Most of the destruction from a tornado that tore through eastern North Carolina Wednesday and struck a large Pfizer pharmaceutical plant affected its storage facility, rather than its medicine production areas, the company said Friday. The …

How Canine Heart Disease was Tied to Grain-Free Dog Food

In 2018, the U.S. Food and Drug Administration, acting on input from a group of veterinary researchers, began investigating whether the increasing popularity of grain-free dog foods had led to a sudden rise in a potentially fatal heart disease in …

J&J Settles Most Risperdal Lawsuits, With $800 Million in Expenses

Johnson & Johnson said it has settled most of the lawsuits it faced by thousands of men who claimed its anti-psychotic drug Risperdal caused them to develop excessive breast tissue and disclosed that it recorded $800 million in expenses in …

J&J CEO Testified Baby Powder was Safe 13 Days Before FDA Bombshell

Facing off against a plaintiff’s lawyer for the first time about Johnson & Johnson’s Baby Powder, the company’s Chief Executive Alex Gorsky earlier this month insisted that the company’s iconic brand was safe. “We unequivocally believe that our talc and …

Walmart Suspends Sales of Zantac as Tainted-Pill Worries Grow

Walmart Inc. plans to suspend the sale of all over-the-counter versions of Zantac, becoming the latest retailer to take such a step as concern over the presence of cancer-causing contaminants in the stomach drug increases. The world’s largest retailer said …

Drugmaker Shredded Quality Documents Ahead of FDA Inspection

An India-based company that sells numerous drugs in the U.S., including ibuprofen, was caught attempting to dispose of quality-control records, calling into question the safety of its medicines. U.S. Food and Drug Administration inspectors said they found what appeared to …