China’s provincial government for Hainan Province has two sets of medical devices going through the urgent medical device needs program, but leveraging this program for regulatory approval in China is still no small undertaking. One complication is that any real-world evidence gathered in Hainan might not suffice for nationwide regulatory approval, but patient recruitment is also difficult.
B-Temia Inc.’s Keeogo mobility device is on the move in the U.S. now that it has received 510(k) clearance from the U.S. FDA. Unlike currently available exoskeletons that move for patients, the Keeogo (keep on going) Dermoskeleton system amplifies signals from patients who can initiate movement but need additional assistance.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, B-Temia, Fitbit, Micron Medical.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm.
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