Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns from the congressional watchdog, the FDA is now garnering plaudits for its embrace of agile and open development. This new way of thinking is central to--and to an extent responsible for--the recently unveiled precisionFDA initiative.
Two leading Indian drug firms once again face quality in manufacturing issues with the U.S. FDA, leading in this case to voluntary recalls even as both face extensive remedial actions to bring plants back into the good graces of the regulator.
Insulet said its long-troubled Billerica, MA, manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.
The FDA recently deemed corrective actions to three devices as Class 1, reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The industry has been wrestling for years now over naming the first wave of biosimilars building on the coast of the American drug industry. The FDA's suggested solution: Take the generic name and add four random letters to make it a unique identifier.
After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. And it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy.
The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing.
When the FDA approved the NeuRx Diaphragm Pacing System to treat chronic hypoventilation in amyotrophic lateral sclerosis (ALS) patients in September 2011 under the Humanitarian Device Exemption (HDE), the agency required an extensive post-marketing study. Now Synapse Biomedical, which markets the neurostimulator breathing device, has reported interim data from that study that's a bit better than the approval data.
Digital health player DynoSense expects to use its new $9.4 million Series A financing to gain FDA clearance for its handheld scanner that grabs more than 33 health metrics, including commonly monitored vital signs, in under one minute. Dubbed the Dyno, the device captures the data and sends it to the cloud for analysis that is subsequently sent to healthcare providers.
Dexcom had put a bit of a Band-Aid on its mobile strategy--its prior smart device-compatible continuous glucose monitor required a separate worn transmitter and a dedicated handheld receiver. But now the FDA has approved the first CGM system, dubbed G5, which connects an all-in-one adhesive sensor/transmitter combo directly to an app on a smart device.