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SUMMARY:FDA Panel Review of GRAIL’s Galleri Multi-Cancer Early Detection Test
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will convene the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on September 23\, 2026\, from 9:00 AM to 6:00 PM ET\, in Silver Spring\, Maryland\, with virtual access also available. \nDuring the open session\, the committee will discuss\, make recommendations\, and vote on GRAIL’s Premarket Approval application for the Galleri® multi-cancer early detection (MCED) blood test. \nGalleri is a prescription-only\, next-generation sequencing-based test designed to detect cancer-specific methylation patterns in cell-free DNA for early detection of multiple cancers in adults aged 50 and older and to predict the likely origin of a detected cancer signal. This will be the first FDA advisory committee review of a PMA application for an MCED test.
URL:https://oncodailynews.com/event/multi-cancer-575897
LOCATION:FDA White Oak Campus\, Building 31 Conference Center – Great Room (Room 1503)\, 10903 New Hampshire Avenue\, Silver Spring\, MD\, 20993-0002\, United States
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DTSTART;VALUE=DATE:20261014
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SUMMARY:Advancing Bioequivalence Frameworks for Inhalation Drug Products
DESCRIPTION:The Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro\, In Vivo\, and In Silico Methods workshop\, co-hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG)\, will take place on October 14–15\, 2026\, in Rockville\, Maryland\, with both in-person and virtual attendance available. \nThe two-day workshop will bring together experts from FDA\, academia\, industry\, and other stakeholders to discuss current regulatory expectations\, scientific challenges\, and emerging approaches for demonstrating bioequivalence of complex generic inhalation products\, particularly metered dose inhalers and dry powder inhalers. \nTopics include realistic particle size distribution studies\, dissolution methods\, particle morphology testing\, in vivo pharmacokinetic studies\, potential alternatives to charcoal-block studies\, strength waivers\, in silico approaches\, and strategies for products with significant formulation differences from their reference standards.
URL:https://oncodailynews.com/event/advancing-bioequivalence-frameworks-570579
LOCATION:The Universities at Shady Grove (USG)\, Building II\, Ballroom\, 9630 Gudelsky Drive\, Rockville\, MD\, 20850\, United States
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