Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
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Welcome to the "Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)" Web-based training course. This course focuses on helping learners gain a general understanding of GDUFA requirements and processes.

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This CDERLearn course is intended solely to provide practical assistance to businesses in complying with the requirements of GDUFA. Because of the delay between creation and publication of these course materials, among other considerations, they may not reflect current FDA policy related to GDUFA and should not be relied on as statements of such policy.
Understanding GDUFA.  Generic Drug User Fee Amendments.
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