Topic:

Regulatory

Latest Headlines

Latest Headlines

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. 

Valeant hit with FDA warning letter for CMO oversight shortcomings

Valeant Pharmaceuticals has grown quickly over the past few years as it has pursued, bought and divested pharmaceutical assets. But somewhere along the way oversight of a supplier slipped. The FDA spotted the problems during a recent visit to Valeant's U.S. headquarters, leading to the posting of a warning letter.

Trinity Biotech expects FDA submission in early 2015 for heart failure Dx

Ireland's Trinity Biotech gained a CE mark for its new heart failure point-of-care diagnostic and is now turning its sights toward the U.S. regulatory process within the next few months.

Salix's Relistor has its chance to get a jump on AZ's new constipation med

Salix Pharmaceuticals nabbed the new Relistor approval it was counting on. The FDA blessed the injectable drug as a treatment for all patients with constipation caused by opioid pain relievers, boosting its target market more than tenfold.

Study: Publicly available information about 510(k) devices' safety and effectiveness lacking

A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.

Homemade medical devices present both challenges and opportunities

Nightscout touts itself as an open source, do-it-yourself project to enable remote monitoring of blood glucose levels of patients with Type 1 diabetes.