The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EMA initiates OPEN collaboration; NICE evaluating guidance processes; Florida researcher indicted.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Quanta, Signifier Medical Technologies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Commonwealth Diagnostics International, Real Time Medical Systems, Seqwell, T2 Biosystems, Zimmer Biomet.
Keeping you up to date on recent developments in neurology, including: Smartwatch sensors enable remote monitoring, treatment guidance for Parkinson’s patients; Imaging of a living brain can help differentiate dementia; Morphine itch comes from neurons, not mast cells.
Mckesson Corp. has brought together several oncology organizations, life sciences companies, and patient advocacy groups to increase understanding of non-small-cell lung cancer (NSCLC) and leverage targeted therapies to improve outcomes. The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) study will observe and analyze 12,000 community-based, metastatic NSCLC patients to learn more about barriers to molecular testing for targeted therapies, how those therapies are being used, and to expand opportunities for participation in clinical trials.
U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.
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