Generic User Fee Waivers Created In Draft House Bill, Breaking FDA-Industry Agreement
FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.
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GDUFA Negotiations Shift To 'Tiered' Fee Models
Finance subgroup talks about new structure for generic drug user fee program that could mean bigger firms would pay more.
GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’
Negotiations for generic drug user fee reauthorization open with FDA saying it doesn't want a large number of small tweaks that will increase program complexity.
Generic User Fees Might Get Brand-Style Exemptions
GPhA and other stakeholders may propose changes to the GDUFA user fee structure amid small business complaints about burden of facility fees.