GDUFA Self-Identification (SPL) Submission - Part 1

Welcome to the "Generic Drug User Fee Act (GDUFA) Self-Identification Structured Product Labeling (SPL) Submission -
Part 1" Web-based training course. This course offers a comprehensive review of the required data elements and their restrictions for the Self-Identification SPL file.

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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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