FDA News

Fears of ‘Wild West’ as Unregulated COVID-19 Tests Hit the Market

Blood tests for the coronavirus could play a key role in deciding whether millions of Americans can safely return to work and school. But public health officials warn that the current “Wild West” of unregulated tests is creating confusion that …

FDA Moving Quickly to Approve New Drugs. Is It Too Quickly?

The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer …

Vaping Firms Sue Seeking to Further Delay FDA Review of e-Cigarettes

A vaping industry group sued the U.S. government last week to delay an upcoming review of thousands of e-cigarettes on the market. The legal challenge by the Vapor Technology Association is the latest hurdle in the Food and Drug Administration’s …

Supreme Court Justices Appear to Favor Merck in Drug Warning Case

U.S. Supreme Court justices on Monday appeared sympathetic to Merck & Co. in its bid to fend off hundreds of lawsuits accusing the company of failing to adequately warn patients of the risks of thigh bone fractures associated with its …

FDA Targets E-Cigarette Makers in Push to Curb Epidemic of Youth Vaping

The U.S. government signaled that it is prepared to adopt a tougher stance on electronic cigarettes in order to stem an epidemic of use by teens and children, after taking a more cautious approach last year. The Food and Drug …

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 …

California Farm Recalls Produce Used in Costco’s E. Coli-linked Salad

A California farm is recalling a vegetable mix believed to be the source of E.coli in Costco chicken salad that has been linked to an outbreak that has sickened 19 people in seven states, the Food and Drug Administration said. …

New ‘Superbug’ Linked to Scope Found at California Hospital

A Los Angeles-area hospital said that some of its patients contracted an antibiotic-resistant “superbug” that has been linked to a type of medical scope and infected dozens of people around the country. Huntington Memorial Hospital said in a statement Wednesday …

Drugmakers Work on Safer Painkillers as Opioid Abuse Epidemic Rages

Backed by a U.S. campaign to slow abuse of prescription painkillers, drugmakers are devising new forms of the medicines that don’t lead to misuse and new products that treat dependency in a bid to change the face of a $9.4 …

FDA Proposes New Food Safety Rules

U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually. The new rules, required by the Food Safety Modernization …