FDA Patient Affairs Office Needed To Improve Conflict Of Interest, NORD Says
Elevating FDA's handling of patient-related issues could help ensure more patients get on advisory committees, rare disease advocates say, but agency notes that waivers are always an option.
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US agency's events could address a touchy subject: how much responsibility does FDA have for preventing adverse events, and how much falls to physicians?
Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.
Biogen/Ionis’ Tofersen: US FDA Considering Both Accelerated And Regular Approval In ALS
FDA seeks advisory committee input on whether there is ‘convincing evidence’ to support regular approval for treatment of SOD1-ALS patients even though lone Phase III trial failed its primary endpoint; companies filed for accelerated approval on the basis that a reduction in plasma neurofilament light chain is reasonably likely to predict clinical benefit.