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 and Granules India each reported surviving a U.S. FDA inspection without any problems being cited.
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 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'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 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.
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.
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.
Drugs can end up on the FDA shortage list for many reasons, with manufacturing problems and recalls often being the culprit. But a new report says that for more than a decade, poor management by the Drug Enforcement Agency and a touchy relationship between the DEA and FDA have been at the heart of many shortages of controlled substances.
The federal agency in charge of running Medicare opposes the integration of unique device identification into insurance claims data, putting it at odds with the FDA and most of the medical community.