The COVID-19 pandemic’s impact on inspections of drug and device manufacturing sites is a matter of record, but the agency says it is on track to resume inspections for high-risk considerations. However, the FDA also said it will likely make more extensive use of virtual inspection tools going forward, a development that may ease some of the operational interruptions engendered by conventional on-site inspections.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amt, My01, Renovacare, Viome.
Once again, the World Trade Organization (WTO) postponed a decision on a temporary intellectual property (IP) waiver for COVID-19 vaccines and other related medical products.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autogen, Axim Biotechnologies, Cell Projects, Centogene, CN Bio, Eagle Genomics, Empowered Diagnostics, Exagen, Femselect, Fluxergy, Gene Group Holdings, Genostics, Heartflow, Isohelix, Konica Minolta, Lina Medical USA, Medaxiom, Nvoq, Oncimmune, Perahealth, Rxbio, Sientra, Spectrum Solutions, Stagezero, United Health Products, US Medical Innovations, Vtnc.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Avisa, Flurotest, Ivenix, Ivwatch, Moleculight, Premier, Sentinel Diagnostics, Smiths Medical, Vizient.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canon Medical Systems USA, Closedloop.ai, Cradle Genomics, Echelon Diagnostics, Ocular Therapeutix, Precipio, Raysearch Laboratories.
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