Guidance Offers IDE Tips For Devices Targeting Brain Disease Progression
This article was originally published in The Gray Sheet
FDA issued a draft guidance to help device-makers conduct clinical trials for products designed to slow the progress of neurological conditions. One challenge highlighted by the agency is that changes to biomarkers measured in a study may not line up easily with disease progression.
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The US agency finalized its guidance on IDEs for devices intended to treat the cause or progression, rather than just the symptoms, of neurological conditions like Alzheimer's.
As Europe’s health emergency body HERA approaches its first anniversary, an unprecedented range of stakeholders including industry bodies will be meeting in December to discuss HERA’s achievements, while a separate event will showcase the next generation of vaccines for COVID-19 and other infections.
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