FDA Biomarker Qualification Program - Has anyone prepared an application?

Dobby1979

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#1
Happy Monday everyone!

Does anyone have much experience with the BQP program. From what I can see, no companies have gone the program since the draft guidance was published in 2018, there are a number of applications in though.

Has anyone prepared an application under the BQP? How much time would it take to prepare one? Does anyone have a checklist for everything that is required?

Thanks.
 
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