Welcome to the "Generic Drug User Fee Act (GDUFA) Self-Identification Structured Product Labeling (SPL) Submission -
Part 2" Web-based training course. This course focuses on guiding firms through the successful submission process including uploading SPL submissions and retrieving acknowledgements.
Click the NEXT button to view instructions for navigating the course.
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.