Cryptocurrency Q&A
What is the difference between gdufa i and gdufa ii?
What is the difference between gdufa i and gdufa ii?
CryptoPioneer
Thu Sep 05 2024
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5
answers
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Could you please elaborate on the key distinctions between GDUFA I and GDUFA II? How do they differ in terms of their objectives, scope, and the impact they've had on the generic drug industry? Are there any notable changes in regulations or fees that businesses need to be aware of when transitioning from one program to the other?
5 answers
Davide
Sat Sep 07 2024
GDUFA II introduces a significant change in the refund policy for sponsors who voluntarily withdraw their Abbreviated New Drug Applications (ANDA) before the Food and Drug Administration (FDA) makes a decision on their acceptance. This change aims to incentivize sponsors to withdraw their applications promptly, reducing unnecessary workload for the FDA and saving time for the sponsors.
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Arianna
Sat Sep 07 2024
Specifically, under GDUFA II, if a sponsor voluntarily withdraws an ANDA before the FDA makes a decision, they are eligible to receive a partial refund of the fees paid. This refund mechanism encourages sponsors to be more deliberate in submitting their applications and to withdraw them promptly if they determine that they are not viable.
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QuasarGlider
Fri Sep 06 2024
In contrast, under the previous version of GDUFA (GDUFA I), facilities that qualified as both Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) manufacturers were required to pay both sets of fees. This dual fee structure added to the financial burden of manufacturers and may have discouraged some from participating in the program.
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Silvia
Fri Sep 06 2024
The introduction of the partial refund policy under GDUFA II is a welcome change for sponsors, as it reduces the financial risk associated with submitting ANDAs. It also helps to streamline the FDA's workload by discouraging the submission of unnecessary or incomplete applications.
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ZenHarmony
Fri Sep 06 2024
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