Topic:

Regulatory

Latest Headlines

Latest Headlines

Zogenix races to FDA with abuse-deterrent version of maligned pain pill Zohydro

Ever since the FDA approved Zogenix's all-hydrocodone painkiller Zohydro last year, both the agency and the company have faced a storm of criticism. The powerful pill, without tamper-resistant features, was destined to be abused, they claimed.

Philips gets apps FDA-cleared, launches psoriasis device after HealthTech refocus

Philips is getting serious about consumer health, staking the entire business on merging its healthcare and consumer units into one company focused on health tech. It will spin off the lighting business into a separate company next year.

FDA finalizes cybersecurity guidance in push to secure devices from hackers

The FDA announced that it has finalized its guidance on managing cybersecurity risks as it aims to protect patient privacy and prevent devices from malfunctioning due to computer viruses.

Judge won't toss dinner-party kickback claims against Novartis

Note to sales reps: You might think twice about inviting the same doctors to the same speaker events over and over. Particularly when those events involve pricey dinners at Nobu and Smith & Wollensky.

Warning to Gilead, AbbVie and BMS: France has a new tax for pricey hep C meds

European countries are known for wresting price cuts from drugmakers. Usually, it's a straightforward cost-effectiveness argument. But France has come up with a new strategy: Arm-twisting taxes.

FDA spotlights innovation in 3-D imaging

Breast cancer detection may soon leave 2-D mammography in the dust, embracing instead a more comprehensive diagnostic tool: 3-D technology.

India sending inspectors on facility visits with global peers

Over the past year India has begun to face up to the reality that its regulatory machinery is insufficient to enforce quality standards, leading authorities to commit to hiring more inspectors. Now those new inspectors are tagging along on inspections run by their international peers.

Novartis dinner-party kickback case must go on, judge says

In an order filed Tuesday, U.S. District Judge Paul Gardephe refused to dismiss claims that Novartis lavished entertainment on certain physicians in return for increased prescriptions.

Health Canada places import ban on Apotex and IPCA Laboratories

Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.

Allergan's drug-delivering eye implant gets expanded indication from FDA

Allergan announced that the FDA has approved the company's Ozurdex sustained-release biodegradable implant to treat diabetic macular edema (DME). The expanded indication means the therapy, based on a proprietary delivery system, is approved for use in the general DME population, not just those with an artificial lens implant or in need of cataract surgery.