The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Evidence does not back hearing loss screening for asymptomatics; Boston Scientific settles on mesh marketing; FDA says approval phase for Barostim Neo was 240 days.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biotia, Diazyme, Helio Health, Letsgetchecked, Mesi, Natera, Tempus, Tivic Health, Twist Bioscience.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Ascentage, Berg, Enterome, Horizon, RDIF, Reneo.
CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Canadian government, Center for Drug Evaluation and Research, EMA, Stop TB Partnership, Therapeutic Goods Administration.