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Guidance for Industry
This guidance describes the types of user fees authorized by PDUFA VI, the process for submitting payments to FDA, the consequences for failing to pay
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2 CFR 200.407 - Prior written approval (prior approval).
The absence of prior written approval on any element of cost will not, in itself, affect the reasonableness or allocability of that cost unless prior approval
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8.1.2 Prior Approval Requirements
A description of the activities and/or expenditures that require NIH prior approval, including a summary table.
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