Biomarker Approvals At Pre-IND Stage Requested For Orphan Drugs
Executive Summary
Updated draft white paper on expanding use of accelerated approval suggests FDA approve the use of biomarkers as surrogate endpoints in the pre-IND stage, which could enhance sponsors’ abilities to raise funds for trials and manufacturing.
You may also be interested in...
Sharpless Wonders Why Cancer Success Doesn't Translate To Other Diseases
Acting US FDA commissioner also said he wants to be nominated to the permanent position.
'Progressive Approval' Coming? US FDA Considers Accelerated Approval Without Surrogates
Commissioner Gottlieb tells Congress that concept could be used for some clinical endpoints when a large benefit is seen in a small trial, which could benefit rare disease drug development.
Biomarkers Qualification: Can FDA Get Rolling Before A Push From Congress?
FDA has been reluctant to lay out evidentiary standards for biomarker qualification, but its call for information on promising candidates may be an initial step toward creating such a framework.