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Drug Development Tool Qualification: US FDA Offers Three-Step Review Process

 
• By Brenda Sandburg

FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle. 

Big medical set including equipment , medical tools and drugs. Vector hand drawn medical collection - Vector

The US FDA has set up a three-step review process to qualify tools for use in drug development. But before beginning this procedure, the agency first determines the "reviewability" of a sponsor's submission.

FDA officials described how the agency is implementing the new qualification process for drug development tools, established by the 21st Century Cures Act, at a Dec. 11 public meeting. Enacted...

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