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.
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Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
The US FDA’s capacity planning formula indicates a smaller biosimilar program than a year ago, but says supplement, meeting and other work continue to increase.