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Biomarker Approvals At Pre-IND Stage Requested For Orphan Drugs

 
• By Derrick Gingery

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.

A rare disease group is pressing FDA for more systematic biomarker qualification, including a pre-IND stage approval process, arguing that it holds the key to expanding orphan drug development.

An updated

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More from North America

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