The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaxis, Amicus, Anokion, Applied Therapeutics, Ascendis, Innova, Leap, Mereo, Telix.
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted a proposed rule for coverage of FDA-designated breakthrough devices, a programmatic objective that has been front and center for the agency for several years. However, Tamara Syrek Jensen, director of the Coverage and Analysis Group (CAG) at CMS, said the proposal to redefine the term “reasonable and necessary” may be the more critical piece of the proposed rule because it would give the agency unprecedented flexibility in covering a broad swath of medical technologies.
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).
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