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US FDA Drug Development Tool Qualification Takes Center Stage At December Meeting

 
• By Sue Sutter

Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.

Leather tool belt with construction tooling on wooden board maintenance concept.
Tools of the drug development kind are the focus of a Dec. 13 FDA public meeting.

The US FDA’s upcoming public meeting on a scientific framework for drug development tool qualification marks an early step in its implementation of 21st Century Cures Act and PDUFA VI provisions aimed at speeding development with the help of biomarkers, animal models and clinical outcome assessments.

The agency will hold a Dec. 11 meeting to discuss and seek input on the drug development tool (DDT) qualification...

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