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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,...

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