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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 draft white paper on the expansion of the use of accelerated approval (AA) continues to ask...

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• By Bridget Silverman

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