The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will be venturing into new territory April 15 in which it not only has to consider whether the benefit of Celltrans Inc.’s donislecel is clinically meaningful, but it also will have to define the indication.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Avenue, Axcella Health, Celularity, Janssen, Kibow, Lintonpharm, Neuraptive, Novartis, RDIF, Vtv.
The FDA and the CDC have jointly recommended a temporary pause in the further rollout of Johnson & Johnson Co.’s COVID-19 vaccine while they investigate six rare clotting cases in adults ages 18 to 48.
Cosmo Artificial Intelligence Ltd. received the FDA’s nod for its GI Genius intelligent endoscopy system. The device – the first of its kind, according to the agency – uses artificial intelligence (AI)-based on machine learning to improve the detection of lesions during colonoscopy. It will be rolled out in the U.S. by Medtronic plc, which has exclusive worldwide distribution rights.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic recalls electrophysiology units over battery depletion; ASCA labs listed by FDA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cosmo, Lucira Health, Masimo, Medtronic, Myhomedoc, Thermo Fisher Scientific.
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.”
If the U.S. Congress is receptive to recommendations approved by the Medicaid and CHIP Payment and Access Commission (MACPAC) April 9, the FDA's accelerated approval path for innovative new drugs could lose a bit of its appeal. And sponsors using that path may speed the pace of seeking full approval.