Topic:

Regulatory

Latest Headlines

Latest Headlines

Congress considering bill to limit FDA regulation of EHRs, clinical decision support software

A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.

AstraZeneca, Ranbaxy unable to kill Nexium pay-for-delay lawsuit

AstraZeneca and Ranbaxy Laboratories have been unable to wiggle out of a pay-for-delay case that said they colluded to keep generics of AstraZeneca's blockbuster heart medicine off the market until its patent expired in May 2014. The drug is still not on the market but at this point it is not because of backroom deals but because of FDA oversight and Ranbaxy's drug testing mess ups.

J&J hopes third time is the charm for antitumor agent Yondelis

Five years after the FDA formally rejected J&J's Yondelis (trabectedin) for ovarian cancer, and three years after an aborted effort to get it back on track, the pharma giant has finally made its way back to the agency for another try at an approval--this time as a treatment for soft tissue sarcoma.

UPDATED: Covidien gets 510(k) for peripheral balloon catheter aimed at hemodialysis patients

Covidien today announced FDA 510(k) clearance for its Fortrex percutaneous transluminal angioplasty balloon catheter, designed to maintain arteriovenous access in hemodialysis patients suffering from chronic kidney disease or end-stage renal failure.

FDA cracks down on power morcellator devices in updated safety guidance

Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.

U.K. gatekeepers toughest on cancer meds--and getting tougher all the time

The U.K.'s cost gatekeeper is notoriously strict when it comes to approving drugs, shooting down meds based on strict cost-effectiveness standards or saddling them with restrictions. But cancer drugs could face the toughest road ahead, as a new report shows that the National Institute of Health and Care Excellence is less likely to green-light the meds compared to other classes of drugs.

Feds want more trial results made public

The Department of Health and Human Services and the National Institutes of Health are proposing new rules that would greatly expand the number of clinical trials required to publicize their results, a move that could change how CROs handle data.

CAR-T player Juno picks up 'breakthrough' status for lead cancer therapy

Biotech upstart Juno Therapeutics has added an FDA "breakthrough" drug title to its considerable list of accomplishments, gaining regulators' commitment to hurry along a lead cancer program to a potential approval.

FDA approves Avantis Third Eye device for colonoscopies

The FDA approved Avantis Medical's colonoscopy imaging device that is capable of showing a wide-angle image of more than 300 degrees during colorectal cancer screening procedures.

EMA, like FDA, says testosterone-raising drugs are not for lifestyle use

The European Medicines Agency has thrown more cold water on sales of testosterone-raising meds as a party drug for aging men. The agency said today that the evidence is inconsistent about the cardio risks of the drugs, but they should only be reserved to treat men whose level is low because of a medical condition.