Topic:

Regulatory

Latest Headlines

Latest Headlines

Covidien's 980 Ventilator Systems potentially deadly, recalled by FDA

The FDA has hit Covidien's Puritan Bennett 980 Ventilator Systems with its most severe Class I recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Amgen takes another stride in frenzied race toward the PCSK9 finish line

Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted its BLA application on the PCSK9 drug for review, giving regulators until August 27, 2015 to issue their decision on marketing the therapy.

Device for minimally invasive treatment of enlarged prostate gains CMS reimbursement

Minimally invasive surgery to reduce the incidence of erectile dysfunction and other nasty side effects of procedures to treat an enlarged prostate is now more accessible due to Medicare reimbursement, NeoTract, maker of the UroLift System, announced today.

Biotronik resolves kickback allegations in $4.9M settlement with feds

Germany's Biotronik agreed to pay $4.9 million to the government to settle allegations that it paid kickbacks to doctors in Arizona and Nevada to persuade them to use its devices.

Power morcellation ban unlikely, but other FDA restrictions coming soon

The doctor who brought the cancer risks posed by power morcellation to the attention of the public and the FDA protested what he described as "imminent plans to use legal mechanisms to functionally institute a 'registry of outcomes' or a 'probationary period' in order to avoid banning power morcellators from the marketplace," in an email to Commissioner Hamburg, various U.S. senators, White House officials and others obtained by FierceMedicalDevices.

Avanir's odds for a timely drug approval aren't looking so good

Avanir Pharmaceuticals, awaiting FDA approval for a new migraine treatment, got a letter from the agency pointing out flaws in submitted data, a regulatory hiccup that could derail the company's plans.

Rockwell clears an FDA hurdle with its dialysis drug

A group of FDA advisers voted in favor of approving Rockwell Medical's iron-replacement treatment for dialysis patients, setting aside concerns about the drug's pivotal data and burnishing the company's hopes of finally launching its top prospect.

FDA tightens reins on equine compounding companies

The FDA continues to tighten the reins on animal drug compounding, most recently by sending three companies warning letters targeted at equine products they allegedly marketed without first getting regulatory approval.

FDA advisers spurn Novartis' blood cancer drug, putting approval in doubt

Novartis' new multiple myeloma is treatment too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the cancer drug next year.

Spark snags a 'breakthrough' tag for its Phase III gene therapy

Gene therapy startup Spark Therapeutics has picked up the FDA's coveted breakthrough-therapy designation for its lead candidate, a one-time treatment that promises a permanent solution some rare eye diseases.