Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Arch, Cassi, Cytodyn, Enochian, Heat, Helsinn, Insmed, Kiniksa, Lupin, Sound, Taiho.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment program (ASCA) seems to promise a much less burdensome approach to device performance testing, but several stakeholders have made the case that as written, the draft guidance for the ASCA pilot does little more than create another layer of review of device testing, thus defeating the point of making more extensive use of testing labs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Medtronic, Opti Medical Systems.
The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baylx, Genmab, Lupin, Macrogenics, Merck, Moleculin, Mylan, Oncolys, Pharmaessentia, Polyneuron.
Hydrocephalus involves the buildup of excess fluid in the brain. It affects more than 1 million people in the U.S. – most of them children – and can result in brain damage and related neurological impairments. Shunt implants are the standard treatment to drain that fluid, but more than half of them fail within the first couple of years of placement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Roche, Synedgen, Transit Scientific.
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