Food and Drug Administration News

FDA Urges Virtual Patient Visits as Coronavirus Disrupts Clinical Trials

The U.S. Food and Drug Administration on Wednesday recommended switching to virtual patient visits instead of in-person monitoring for clinical studies, as signs emerge that the rapid spread of the coronavirus outbreak is disrupting trials. U.S.-based Iveric bio Inc delayed …

Juul Labs Sought to Court State AGs as Teen Vaping Surged

WASHINGTON — Juul Labs, the nation’s largest electronic-cigarette company, donated tens of thousands of dollars to the campaigns of state attorneys general in an effort to build relationships with these powerful officials and potentially head off legal challenges over how …

Mixed Messages, Test Delays Hamper U.S. Coronavirus Response

Even as U.S. officials warn of an inevitable outbreak of coronavirus in the United States, and are alerting Americans to take precautions, some health agencies charged with protecting the public appear unprepared to deal with the threat. Barely more than …

Cancer Risk Forces Recall of Weight-Loss Drug Belviq

Weight-loss drug Belviq will be withdrawn from the U.S. market at the request of the Food and Drug Administration, after research tied it to increased rates of cancer. Belviq came on the market in the U.S. in 2012 and is …

Juul Bulks Up Science Staff With FDA Vaping Deadline Nearing

Juul Labs Inc. has hired former Food and Drug Administration employees and is recruiting more researchers as it prepares for a crucial regulatory hurdle that will determine the future of the top U.S. e-cigarette maker. The company and its peers …

FDA to Hold Public Meeting on Testing for Asbestos In Talc

SILVER SPRING, Md., — For the first time in nearly 50 years, the U.S. Food and Drug Administration will examine asbestos testing for talc powders and cosmetics at a hearing on Tuesday. Regulators are taking a closer look after finding …

FDA’s Juul Inquiry Found Consumers Had 2,600 Health Complaints

Juul Labs Inc. received roughly 2,600 complaints about adverse health effects related to its e-cigarette during its first three years in operation, with customers citing issues such as burning sensations in the lungs, blistered lips and vomiting, according to an …

Government Experts Urge New Talc Testing Standards Amid Asbestos Worries

An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions and reflect those of public health authorities and experts for thousands of plaintiffs who allege contaminated talc …

FDA Under Fire for Years of Delays on E-Cigarette Regulation

As the FDA pressures e-cigarette firms to stamp out youth vaping, the agency faces criticism itself for failing to rein in the fast-growing industry after years of bureaucratic delays dating back to the Obama administration. Despite recent tough talk, the …

Drug-Plant Inspections Ebbed as Tainted Pills Flowed to U.S.

Inspections of foreign drug manufacturers by the U.S. Food and Drug Administration have fallen in recent years despite increasing worry about the safety and quality of generic medications, congressional investigators said. FDA inspections of overseas pharmaceutical manufacturers declined 10% from …