FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients that it shipped for use in U.S. drugs.
Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.
Medtronic disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just made by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.
In the next few weeks, the FDA will rule again on a prescription treatment for female sexual dysfunction. This is the third time the FDA has considered Sprout Pharmaceuticals' drug flibanserin, which has been rejected twice. This time, however, it has its best chance yet of getting approved, having already gained an FDA advisory panel nod in June.
Melbourne, Australia-based Adherium has pulled off a major pharma partnership just ahead of a proposed listing on the Australian Stock Exchange. It expects to list on Aug. 26, raising up to $35 million and at least $20 million. A new deal that the smart inhaler player just disclosed with AstraZeneca can only enhance its public market prospects.
Gynesonics has received $43 million from investors to support the clinical development of its Sonata System, which uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance in a transcervical procedure that preserves the uterus.
The FDA has made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers has attracted a chorus of critics worried that it could go too far at the expense of patients.
Upstart Langford IC Systems claims that it's launching the only system that meets FDA standards for reprocessed medical device cleanliness. Its first buyer is the Ronald Reagan UCLA Medical Center in Los Angeles, which reported two patient deaths and several infections earlier this year due to insufficiently disinfected duodenoscopes, which are a type of endoscope for examining the duodenum.
The U.S. Food and Drug Administration has approved the iDesign Advanced WaveScan Studio System from Abbott Laboratories. The company has already launched the system, which is based on a 3-D map of the eye that's expected to improve the accuracy of Lasik procedures.
The FDA has approached Google for help identifying adverse drug events in search data. The regulator hooked up with Google to access the insights of Evgeniy Gabrilovich, an engineer at the tech behemoth who has published papers on the subject of mining search queries for adverse event reports.