I am trying to understand the distinction between Gdufa II and Gdufa III. I want to know the key differences between these two entities, possibly in terms of their scope, objectives, or any other significant aspects.
7 answers
CryptoPioneer
Mon Oct 28 2024
The GDUFA II framework established certain guidelines for communication between regulatory bodies and applicants.
CryptoWizard
Sun Oct 27 2024
Under this framework, correspondence that sought regulatory and/or scientific advice after the issuance of a Complete Response Letter was categorized as general correspondence.
Pietro
Sun Oct 27 2024
This shift in categorization is significant as it reflects an evolution in the regulatory landscape.
InfinityEcho
Sun Oct 27 2024
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Maria
Sun Oct 27 2024
Similarly, correspondence that sought advice after receiving a tentative approval or after ANDA approval was also considered general correspondence under GDUFA II.