Bending PDUFA’s Cost Curve: PhRMA Looking For Sustainable Program Growth
Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.
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The agency reissued the user fee notice, saying fewer dollars were needed for new staff.
User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.