Latest Headlines

Latest Headlines

FTC warns consumers against buying unapproved weight-loss devices

Alongside the FDA, the Federal Trade Commission oversees the marketing and promotion of medical devices. FTC Consumer Education Specialist Aditi Jhaveri took to the agency's blog to warn consumers against purchasing unregulated devices that promote "do-it-yourself" projects, such as weight loss.

The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews

Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.

FDA slaps most serious label on MicroPort hip implant device recall

China's MicroPort earned the FDA's most serious designation over a recall of devices used in hip joint replacement surgery after reports surfaced that showed the products could be endangering patients' lives.

FDA orders postmarket studies from trio of duodenoscope makers as 'superbug' scare continues

The three manufacturers that market duodenoscopes in the U.S. have all been required by the FDA to submit postmarket surveillance plans to the agency within 30 days. This comes after all three received warning letters from the agency in August and an FDA committee panel took up the same issue in May.

FDA marketing police most likely to slap pharma for risk-info omissions

Want a surefire path to an Office of Prescription Drug Promotion (OPDP) warning letter? Leave side effects out of a drug promo, a new analysis says. As a team of Johnson & Johnson execs found, 60% of the FDA warning letters and untitled letters issued by OPDP between 2013 and 2015 cited pharma for omitting risk information in promotional materials. 

Want to get a warning letter from OPDP? Omit drug risks from your promos

Sometimes it seems that the FDA has a scattershot approach to policing pharma marketing, with warning letters few and far between--and some of them lobbed from left field. But there's one tried-and-true way to invite unwanted attention from the agency's marketing police: Leave side effects out of drug promos, according to an analysis presented at a recent conference.

UPDATED: Merck's Keytruda snags FDA approval for NSCLC, but label is narrow

Chalk up another approval for Merck & Co.'s Keytruda. And it's a significant one, as it fights for market share against Bristol-Myers Squibb's Opdivo in the PD-1/PD-L1 field. The FDA Friday gave an accelerated approval for Keytruda for use on advanced non-small cell lung cancer (NSCLC). Opdivo is awaiting an accelerated approval.

On second thought, Amicus won't be filing its lead drug this year

Amicus Therapeutics, a biotech comeback story, is walking back plans to submit its rare disease treatment for FDA approval this year, rethinking its whole regulatory strategy after follow-up conversations with the agency.

JAMA: 'Breakthrough' talk in FDA press releases could unfairly sway consumers

Is the FDA overpromising and underdelivering? A recent study shows that when the agency uses terms such as "breakthrough" or "promising" in statements about a med, it could sway individuals' perceptions about how well the drug actually works.

Manufacturing issues result in another blow to Sun Pharma from FDA

Continued problems at Sun Pharmaceutical's Halol facility in India sparked the U.S. Food and Drug Administration to pull its approval for the company's research arm to launch a drug for seizures.