Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cochlear, GI Supply, Indica Labs, Inivata, Lumiradx, Medtronic, Sight Diagnostics.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
The FDA has posted a draft guidance responding to changes in the law regarding device shortages during public health emergencies. The guidance says that manufacturers should advise the FDA of any impending shortages, but the key qualifier, that of a “meaningful disruption” in production, may be sowing confusion in the industry.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 23andme, Abiomed, Medtronic.
This could be a make-or-break week for Biogen Inc., with the U.S. Centers for Medicare & Medicaid Services (CMS) expected to announce a draft coverage decision for the company’s Alzheimer’s drug, Aduhelm.
After 25 years of research. Allschwil, Switzerland’s Idorsia Ltd. has had its first drug approved by the FDA – Quviviq (daridorexant) for adults with insomnia. The okay for Quviviq is the result of painstaking research led by the firm’s chief scientific officer, Martine Clozel, whose husband Jean-Paul Clozel is CEO.
FDA commissioners past, present and likely future gathered together for a rare joint discussion Jan. 9, as part of the third annual Innovations in Regulatory Science Summit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Dynacure, Moderna, Paxmedica.
RSS
