Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, BMS, Daiichi, Eisai, GW, Histogen, Hope, Mallinckrodt, Mateon, Mesoblast, Novo Nordisk, Takeda, Tetra, Tracon.
TORONTO – Canadian Prime Minister Justin Trudeau has yet to rule out following U.S. President Donald Trump’s lead by invoking his nation's wartime Defense Procurement Act compelling manufacturers to begin making ventilators to combat COVID-19. For now, Ottawa has signed contracts or letters of intent with eight equipment makers.
The U.S. Federal Communications Commission (FCC) has received funds for another telehealth program in less than a year. An agency statement indicates that the program “would immediately support health care providers” working to thwart the COVID-19 outbreak. This would be achieved in part by supporting purchases of devices and other items needed to provide telehealth, which the Connected Health Initiative said will help drive an overdue overhaul of health care in the U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Beroni Group, Biogx, Clinical Laserthermia Systems, Leica Biosystems.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments.