Infectious Disease
News on research and diagnostic development for pathogenic diseases.
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
Project Africa GRADIENT aims to gather and analyze pharmacogenetic data specific to African populations with funding from Novartis and GlaxoSmithKline.
FDA to Review Vertex Pharma's NDA for 'Vanza Triple' Cystic Fibrosis Regimen
Vertex's regulatory application for the triplet combination has priority review from the agency and has been validated by the European Medicines Agency.
FDA's Center for Devices and Radiological Health Plans Reclassification Process for High-Risk IVDs
Reclassifying certain of these tests from high risk to moderate risk could allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.
The firm is offering molecular diagnostic testing and clinical trial services to bridge knowledge gaps and increase access to personalized care locally.