Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Once-rejected drugs in Gilead's Stribild get FDA nod to go it alone

Gilead has been seeking FDA approval for HIV drugs Tybost and Vitekta for a while now, but the agency dealt the drugmaker a setback with Complete Response Letter last year. Now, 17 months later, the two have passed muster.

Japan approves Infraredx's intravascular ultrasound Dx imaging device

Infraredx isn't a big company yet. But the Massachusetts maker of an intravascular imaging system designed to help diagnose and manage coronary artery disease continues to meet major goals for international expansion. The latest: Japan's regulators granted approval for its signature device.

Court rules that FDA cannot rescind 510(k)s without notice and comment procedures

The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress' procedural requirements when reclassifying devices, including notice and comment procedures. 

FDA warns of contaminated Chinese meds after toddler suffers lead poisoning

The problem of contaminated cold remedies has once again surfaced in the U.S. More than seven years after diethylene glycol put authorities on high alert, a toddler in New York has suffered from lead poisoning after taking a Chinese cold remedy.

Bristol-Myers' oncology star lines up for lung cancer approval, leading the PD-1 pack

Among the scrum of drugmakers racing forward with a new class of cancer treatments, Bristol-Myers Squibb was the first to win a global regulatory nod and is now first in line for approval in lung cancer, a particularly lucrative indication for the group of promising oncology drugs.