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Questions tagged [gdufa i]

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CryptoPioneer CryptoPioneer Thu Sep 05 2024 | 5 answers 1115

What is the difference between gdufa i and gdufa ii?

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?

What is the difference between gdufa i and gdufa ii?

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