The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex, Image Processing Technologies, Smith & Nephew.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hai Kang, Philips, Sinapi Biomedical, Truvian.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Inovio, Melt, Merck, Novartis, Regulus, Relief, Ridgeback, Roche, Scynexis, Teva.
The U.S. government has charged two citizens of China with cybercrime in connection with purported hacking of research into vaccines for the SARS-CoV-2 virus, but more than one speaker on a July 22 webinar said scientists involved in basic life science research at universities fail to appreciate the need for cybersecurity, a problem they may take with them to the private sector.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neocis, Nowdiagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apogenix, Black Diamond, Chi-Med, Foresee, Hemoshear, Larimar, Momenta, Nabriva, Protara, Realta.
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