FDA News

U.S. Regulators Say Tests for Lead Poisoning May Be Faulty

U.S. health agencies on Wednesday warned that certain blood tests for lead poisoning may give results lower than the actual level of lead. As a result, some children under 6, along with pregnant and nursing women, may need retesting, the …

Side Effects Aren’t Always Discovered Prior to FDA Drug Approval

Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications, a new analysis found. The results covered all 222 prescription drugs approved by the …

Fires, Injuries Caused by E-cigarettes on the Rise

Katrina Williams wanted a safer alternative to smoking, and e-cigarettes seemed to be the answer until the day one exploded in her pocket as she drove home from a beauty salon. “It was like a firecracker,” the New Yorker said, …

Pro-Painkiller Echo Chamber Shaped Policy Amid Drug Epidemic

For more than a decade, members of a little-known group called the Pain Care Forum have blanketed Washington with messages touting prescription painkillers‘ vital role in the lives of millions of Americans, creating an echo chamber that has quietly derailed …

New Rules Expected to Impact E-Cigarette Industry

The federal government on Thursday announced sweeping new regulations for electronic cigarettes that could upend the multibillion-dollar industry and for the first time require e-cigarette makers to submit their products for a safety review. Before brands are allowed to stay …

Senator Wants Medtronic, FDA to Release Bone Graft Injury Data

U.S. Senator Al Franken asked federal regulators and Medtronic Inc for detailed information about injuries associated with the company’s bone graft Infuse following a newspaper report that Medtronic hid thousands of adverse events linked to the product. The Minneapolis Star …

Fast-Acting Opioid Painkillers to Carry Strong New U.S. Warnings

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 …

Most Powdered Surgical Gloves Likely to be Banned

Federal health officials are moving to ban most surgical gloves made with powder, a feature designed to make them easier to wear, but which actually poses health risks to patients. The Food and Drug Administration said Monday that the powder …

Recent Ban on E-Cigarettes in Checked Bags Highlights Risks

Focus on the risks associated with electronic cigarettes continues to rise as their popularity continues to grow. Electronic cigarettes, or e-cigarettes as they are often referred to, are typically a battery powered cigarette look-alike designed to deliver the same nicotine …

FDA Drafts Cybersecurity Guidlines for Medical Devices

The U.S. Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in their devices. “Cybersecurity threats to medical devices are a growing concern,” the agency said in a …