ANDA User Fee Proposal From Industry Relies Heavily On Establishment Fees
This article was originally published in The Pink Sheet Daily
The plan would require 80% of generic drug user fee revenue to come from finished dosage manufacturers and 20% from API manufacturers.
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GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.
CDER report calls for broader partnerships with outside bodies in regulatory science.
Industry and FDA appear largely in agreement on goals for the generic drug user fee program after it gets off the ground, but are stuck on how to determine agency performance in its early years.