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Episode 60

Biotech Hangout

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The Role of Clinical Holds in FDA Decision Making

FDA's Peter Marks said at a conference that there's that they want to find a way to manage clinical holds. That's more user friendly, noting that CBER is going to work more closely in advance with sponsors. I think like one of the biggest issues in our industry is the so passady this, you know, the surprises that you get sometimes when it comes to what companies think and then what ultimately gets disclosed regarding FDA.

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