Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA clears syringe that prevents needlestick injuries

Exton, PA's West Pharmaceutical Services just announced that the FDA has given it 510(k) clearance for the NovaGuard Staked-needle Automatic safety system, as the push to avoid needlestick injuries gathers momentum.

Threshold shares surge as PhIII cancer program enters FDA's fast track

Shares of Threshold Pharmaceuticals jumped about 10% this morning on news that the FDA is granting fast-track status to TH-302, the company's sole therapy now in a pair of late-stage cancer studies.

UPDATE: Cadila Pharmaceuticals API plant slapped for faulty follow-up on stinking APIs

When India's Cadila Pharmaceuticals got complaints from customers about some of its APIs smelling bad, the drugmaker decided the odor stemmed from an impurity, so it tweaked the manufacturing process. The problem, according to the FDA, is that the plant never conducted an investigation to determine whether the impurity was in fact the cause, so the company never knew whether it had really resolved the cause of the stench.

Some psych experts want FDA to yank black-box warning on antidepressants

In the 10 years since the FDA found that antidepressants carried an increased risk of suicidal thoughts and behaviors in teens and slapped a black box warning on the drugs, psychiatry experts remain divided on the warnings' efficacy, with some calling for a removal of the label altogether.

UPDATED: China FDA's new medical device importation regulations shorten review period

China's registration review process for imported medical devices and in vitro diagnostics has been shortened under new China FDA importation regulations that took effect last month, and companies that fail to follow the guidelines will not get a second chance, meaning any mistakes could prove fatal to a product's chances in China.

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.