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New Translational Science Team Created In US FDA’s CDER To Aid Rare Disease Drug Development

 
• By Derrick Gingery

The group is intended to help rare disease drug developers answer all the necessary questions about surrogate endpoints and markers before the application review cycle.

rare disease blocks
The translational science team would be similar to one working on real-world evidence. • Source: Shutterstock

The US Food and Drug Administration wants rare disease drug sponsors to know very early what questions need to be answered about potential surrogate markers in order to avoid confusion at the application review stage.

Center for Drug Evaluation and Research Director Patrizia Cavazzoni said 13 June that the center is creating a translational science team that would help FDA reviewers and sponsors understand the...

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