The feds rejected a whistleblower's complaints that the FDA erred when it approved imaging devices for breast and colon cancer screening.
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.
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.
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.
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.
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.
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.
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.
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.
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.