Questions tagged [generic drug user fee]

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Caterina Caterina Thu Sep 05 2024 | 6 answers 1393

What is the Gdufa fee?

Can you elaborate on the Gdufa fee? I'm curious to understand its purpose and how it applies to the pharmaceutical industry. Is it a mandatory fee that drug manufacturers need to pay, and if so, what are the specific circumstances that necessitate its payment? Additionally, how does the revenue generated from this fee contribute to the FDA's operations, and are there any exemptions or discounts available for small or low-income drug manufacturers?

What is the Gdufa fee?

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