Topic:

Regulatory

Latest Headlines

Latest Headlines

What will changes to the Sunshine Act mean for devicemakers?

Medical device manufacturers could soon be looking at additional expenses following proposed changes to the Physician Payment Sunshine Act. 

AcelRx discusses sublingual painkiller's rejection with concerned investors

On the heels of FDA's rejection of the AcelRx New Drug Application for sublingually delivered postoperative pain killer Zalviso, CEO Richard King expounded on the "optical system errors" of the opioid drug's handheld, preprogrammed delivery device during a July 28 conference call with investors.  

China sets trial date for GSK-tied investigators, says it will be 'open'

China will try two private investigators tied to GlaxoSmithKline's operations there in just over a week on charges of illegally purchasing personal information about Chinese nationals, a Chinese court said. And according to state news agency Xinhua, all are welcome to attend.

J&J, Pharmacyclics celebrate yet another nod for leukemia med Imbruvica

Johnson & Johnson's new blood cancer drug Imbruvica (ibrutinib) is on a roll. The FDA just armed the drug with a new indication in chronic lymphocytic leukemia, adding to a series of regulatory nods.

Ranbaxy shakes up its executive ranks for manufacturing oversight

After years of manufacturing lapses left it with four of its 5 FDA-approved plants banned, a consent decree and now a deal to be sold, Ranbaxy Laboratories has cleaned house in its quality oversight ranks.

Impax now faces FDA issues at Taiwan plant that could affect Rytary

The bad news just keeps piling up for Impax Laboratories and Rytary, its investigational drug for treating idiopathic Parkinson's disease. After a series of manufacturing ills at its California plant cost it its partnership with GlaxoSmithKline, the drug developer reports that its fallback facility in Taiwan has also been found lacking by the FDA. 

French devicemaker faces FDA scrutiny for prostate cancer device

French devicemaker EDAP TMS SA is facing FDA scrutiny for its robotic device for prostate cancer, as regulators questioned the product's safety and efficacy in a new report. 

Opinion: Experimental medical devices should be made available to patients

Patients should have the option to take more risks when seeking medical treatment, said Dr. Kevin Tracey in a  Wall Street Journal column.

FDA final guidance modifies 510(k) rules, discourages use of multiple predicate devices

In a new final guidance issued today July 28, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which the agency later said can damage surrounding bones and contaminate the body by releasing ions into the bloodstream.  

Roche, Novartis protest moves in EU to pay for off-label Avastin

Last week, France made its move to knock the Novartis eye drug Lucentis out of drug coverage and move its cheaper cousin Avastin into its place. Now, Novartis and its Lucentis partner Roche are fighting back.