EtherWhale
Thu Sep 05 2024
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6 answers
787
Who pays Pdufa fees?
Could you please elaborate on who is responsible for paying PDUFA fees? Are these fees paid by the drug manufacturers who are seeking FDA approval for their products, or are they shouldered by the FDA itself or other government agencies? Additionally, how are these fees calculated, and what impact do they have on the overall cost of drug development and access to medications for patients? Understanding the specifics of PDUFA fees and their payers is crucial in assessing their role in the drug approval process.
