CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Executive Summary
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
You may also be interested in...
As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing
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.
Lower FY22 PDUFA Fees Realized In US FDA Recalculation For Hiring, Attrition Concerns
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.
US FDA Lowers FY '22 PDUFA Fees Due to Hiring, Attrition Concerns
The agency reissued the user fee notice, saying fewer dollars were needed for new staff.