Drug Information Update- GDUFA Learning Courses Now Available

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The FDA has launched two new web-based learning tutorials on the Generic Drug User Fee Amendments of 2012 (GDUFA) to provide an in-depth understanding of the GDUFA regulations and requirements.

1. "Overview of the Generic Drug User Fee Amendments of 2012" offers a general understanding of GDUFA requirements and processes. It also includes a helpful GDUFA Questions and Answers which includes all the questions and answers addressed throughout the course.
2. "Generic Drug User Fee Amendments Self-Identification Structured Product Labeling (SPL) Submission” is a two-part technical tutorial on how to self-identify with CDER, from start to finish.

• Part 1 offers a comprehensive review of the required data elements and their restrictions for the self-Identification SPL file.

• Part 2 focuses on guiding firms through the successful submission process including uploading SPL submissions and retrieving acknowledgements.

These tutorials are part of the CDERLearn CDER Small Business and Industry Education Series Web-based courses designed to educate the pharmaceutical industry.

Users will receive a certificate of completion at the end of each course but no continuing education credits.
We hope that you find these courses helpful.

Send us your feedback at CDERSBIA@fda.hhs.gov.