Federal Drug Administration News

9 Coronavirus Vaccine Developers Pledge to Uphold Scientific Safety Standards

Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards that their experimental immunisations will be held against, amid a hurried global race to contain the pandemic. The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, in …

U.S. Says 7 Firms Falsely Claiming Products Treat COVID-19

The Federal Trade Commission and U.S. Food and Drug Administration (FDA) have warned seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). The …

FDA Cites Drug Warning Scam Over Online Medications

People who tried to order medicine online or over the phone have received fake U.S. Food and Drug Administration warning letters instead of the products they bought, in what appears to be an international extortion scam, the agency said on …

Trump’s FDA Chief Cites Opioid Epidemic As Top Priority

Opioid painkillers that have led to thousands of deaths and new drug addicts should be the highest priority of the U.S. Food and Drug Administration, said Scott Gottlieb, President Donald Trump’s pick to lead the agency. “The opioid epidemic in …

Oregon Murder-Suicide Lawsuit Blames Chantix Prescriber

A Eugene, Ore. woman whose husband killed the couple’s son and himself has sued the dentist who prescribed her husband a nicotine-cessation drug and the hospital that determined he was not a danger to himself or others two days before …

‘I Wish We Had Acted Earlier,’ Says FDA Chief on Meningitis Outbreak

The head of the U.S. Food and Drug Administration conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center of a deadly meningitis outbreak. Testifying at a contentious congressional …

FDA Needs New Authority Over Compounding Pharmacies: Report

The U.S. Food and Drug Administration’s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released …

U.S. Tells Industry to Further Test Safety of Nanotechnolgy Products

U.S. health regulators said consumer products that use nanotechnology may have unknown effects on the human body, and advised food and cosmetic companies to further study the safety of these tiny particles. The U.S. Food and Drug Administration issued two …

FDA Steps Up Scrutiny of Metal Hip Implants

The U.S. Food and Drug Administration responded to mounting concerns about the safety of metal-on-metal hip implants, saying it would subject the devices to a two-day expert review that could lead to rigorous new standards. The FDA announced on Thursday …