The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capsovision, Orbusneich, Surmodics, Urotronic.
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The latest global regulatory news, changes and updates affecting biopharma, including: Convalescent plasma trials expand; CBD public meeting, generics; ICER updates in CF in MM.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Cryosystem, Athenex, Athersys, Bluebird, Eagle, GW, Neurorx, Novartis, Pfizer, Sinovac, Symbio.
BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
According to the Swiss association for medical technology companies, Swiss Medtech, introducing the new European regulations for medical devices (MDR) and in vitro diagnostics (IVDR) is going to have serious consequences for the sector in Switzerland. This Swiss trade association has just published its biannual survey as part of the 2020 sector study on the Swiss medical technology industry (SMTI).
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ambulatory Surgical Center Association, Dyansys, Neurosurgical Care.
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