FDA News

Forgoing Recalls, Med Device Firms Sometimes Use Doctors to Screen for Defects

Results of a new behavioral study into what influences the decision to recall a defective product found that medical device firm managers may rely on their physician-customers to screen out detectable defects, in lieu of issuing a recall. The study …

Autopsy Confirms Exploding Vape Pen Killed Florida Man

An exploding vape pen hurled fragments into a Florida man’s head, killing him and starting a fire that burned most of his body, an autopsy report said. The Pinellas-Pasco Medical Examiner’s autopsy report released Tuesday confirms the vape pen was …

Rodent Infestation, Filth Found Before Egg Recall

Before a U.S. farm voluntarily recalled 207 million eggs, government inspectors found rodents scurrying in manure pits, equipment that was coated with grime and food debris, and outside a swarm of “large flying insects too numerous to count.” Unsanitary conditions …

U.S. Regulators Consider Ideas for Boosting Medical Device Safety

U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments. The plan from the Food and Drug …

Researchers Say New Blood Test Detects TBIs, Not Concussions

A new blood test approved by the Food and Drug Administration is being characterized by the agency and news reports as a way to detect concussion. But a University at Buffalo expert on concussion says those reports are misleading. “Calling …

Feds to Target High-Risk Alternative Remedies

U.S. health officials plan to crack down on a growing number of unproven alternative remedies, focusing on products containing dangerous ingredients that have occasionally been linked to serious injury and death. The Food and Drug Administration on Monday issued a …

FDA Issues Warning on Herbal Supplement Kratom, After Injuries, Death

Federal health authorities are warning about reports of injury, addiction and death with a herbal supplement that has been promoted as an alternative to opioid painkillers and other prescription drugs The supplement, kratom, made from a plant native to Southeast …

U.S. Salmonella Outbreak Linked to Papayas From Mexico

U.S. health officials say consumers should avoid a variety of papaya from Mexico linked to a salmonella outbreak that has been blamed for the death of a person in New York City and for sickening 46 others in 12 states. …

Panel Calls on FDA to Review Opioid Safety

The U.S. Food and Drug Administration should review the safety and effectiveness of all opioids, and consider the real-world impacts the powerful painkillers have, not only on patients, but also on families, crime and the demand for heroin. That’s the …

Where There’s Vapor: Electronic Cigarettes and Their Risks

Some may have noticed that many “no smoking” signs now include “no e-cigarettes.” A new trend, e-cigarettes are small devices that often look like conventional cigarettes. But that’s not smoke people are exhaling—it’s vapor. E-cigarettes, also known as “vapes,” have …