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.
LONDON – T cells generated as a result of infection with common cold coronaviruses provide cross-protection against being infected with SARS-CoV-2, according to a new study.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Biocryst, Biosight, Deinove, Golden, Noxxon, Nuvalent, Oxurion, Recce, Revive.
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