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Using FDA’s New Drug Development Tool: Start With Narrow Context Of Use

 
• By Bridget Silverman

As FDA gains experience with its new Drug Development Tool qualification process, the agency has found that a narrowly defined patient population and condition-specific measures are preferable.

As the first wave of submissions works through FDA’s new Drug Development Tool qualification process, FDA is finding defining a narrow “context of use” to be a vital – and difficult – basis for getting the agency to qualify a clinical outcome measure.

“One of the key things that we’ve discovered that needs to be determined early on” is “what are you measuring, or the concept of interest, and in what population,” FDA...

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