CDER SBIA Update: GDUFA Learning Courses Now Available

GDUFA Learning Courses Now Available

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.  

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The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

 Email: CDERSBIA@fda.hhs.gov

• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia