Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Antibiotics, lab safety and disease outbreaks top CDC Director Tom Frieden's to-do list

I caught up with Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, last week, prior to his address at the National Press Club in downtown Washington, DC. Other media outlets joined in later. Here are some takeaways from his speech on antibiotic resistance, as well as our conversation.

AcelRx shares plunge after FDA rejects its pain drug/device system

Shares of AcelRx took a painful 30% plunge on Monday morning as investors got a chance to respond to the biotech's announcement late Friday night that the FDA had rejected its application for Zalviso, its sufentanil sublingual microtablet drug/device system for fighting pain.

Court stands with FDA on its approach to antibiotics use in farm animals

Scientific evidence proves a correlation between nonmedical use of antibiotics to fatten farm animals and spikes in antibiotic-resistant infections. So why was a federal appeals court panel divided over whether these drugs can be added to animal feed even if the drugs aren't medically necessary? The short, simple answer is that the FDA has just been giving advice on the practice.