Tag:

FDA

Latest Headlines

Latest Headlines

FDA hustles on opioid guidance to avoid budget meddling

The FDA is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.

FDA will discuss challenges and opportunities of robotic surgery at public meeting this summer

The FDA is putting robot assisted surgery in the spotlight this summer. 

Lawsuit would force FDA to ban or label wheat gluten as ingredient

Celiac sufferer Michael Weber is suing the FDA for dragging its feet on a citizen petition he filed in 2008. The lawsuit attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs.

India's Wockhardt, Granules, suggest recent FDA inspections went well

India's Wockhardt and Granules India each reported surviving a U.S. FDA inspection without any problems being cited.

New faces at U.S. FDA head to India with same message on quality, safety

Just over a year after the outgoing U.S. FDA commissioner made a precedent-setting visit to meet her counterparts, India is getting its second visit by high-ranking agency officials.

Baxter recalls 4.4M components for at-home peritoneal dialysis

Baxter International is working to scale up its dialysis product manufacturing because it's been unable to meet demand. In September 2013, Baxter acquired Gambro for $4 billion, which is slated to be part of the core of the new medical products focus for Baxter, while a new company, Baxalta, will hold all the biopharma assets of the current company.

Merck can't get the sugammadex curse lifted, faces 3rd FDA rejection

Merck's anesthesia drug sugammadex has been cited repeatedly over the years as one of the top experimental meds in the pharma giant's pipeline, a trophy obtained in its megamerger with Schering. But the treatment has racked up a painful series of setbacks over the years, starting with its first rejection at the hands of the FDA 7 years ago and continuing now with a third looming rejection over unresolved questions surrounding a hypersensitivity study performed for its pitch to the agency.

St. Jude's Portico TAVR gets CE mark reinstated after 'false alarm'

St. Jude Medical's transcatheter aortic valve replacement, or TAVR, cardiology device is now commercially available in Europe once again, after its CE mark was suspended following safety concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials.

FDA calls for panel meeting to discuss devices linked to superbug outbreak

Facing increased scrutiny for recent superbug outbreaks tied to duodenoscopes, the FDA is planning to convene an advisory panel to discuss the spread of potentially deadly bacteria through the devices.

Watchdog groups decry FDA's move to let reps hand out journal articles

The FDA rolled out some guidelines last June that would allow drugmakers to hand out medical-journal articles to doctors. And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.