Biomarkers: FDA/Industry Group Shaping 'Points-To-Consider' On Assay Validation
Executive Summary
Critical Path Institute will deliver white paper on key step in biomarker qualification process: concepts to consider in validating assays to measure the biomarker’s performance. White paper has US FDA input, and will in turn help inform agency guidance and internal processes.
You may also be interested in...
A Final Push For US Hepatitis C Eradication Plan In 2024
The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.
Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.
Gene Therapy Cost Effectiveness: US ICER Supports Million-Dollar Prices
Institute for Clinical and Economic Review continues to assign high values to novel gene therapies, suggesting that Orchard’s pending ‘arsa-cel’ for MLD could be cost effective at a price as high as $4 million per treatment.