CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
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US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.
Agency reissued user fee notice, saying fewer dollars were needed for adding staff. After concerns about process misunderstandings, agency withdrew earlier version of fee notice.
The agency reissued the user fee notice, saying fewer dollars were needed for new staff.