User Fees For FY 2017 Make Sponsors Happy, Manufacturers Sad
Executive Summary
Several facility fees will increase next year as application fees drop.
You may also be interested in...
Biosimilar User Fee Forecast: Unchanged Or Lower In FY 2019, US FDA Says
Absence of any fee increases reflects growing numbers of both approved biosimilars and products under development, as well as agency’s commitment to start spending down some of the carryover balance from prior years’ fee collections.
Biosimilar User Fee Forecast: Unchanged Or Lower In FY 2019, US FDA Says
Absence of any fee increases reflects growing numbers of both approved biosimilars and products under development, as well as agency’s commitment to start spending down some of the carryover balance from prior years’ fee collections.
ANDA Holder Fee Will Start With Industry-Driven Database 'Clean-Up'
FDA is again relying on sponsor self-reporting as it launches GDUFA II.