Generic Drug Manufacturers
It's time again to self-identify FDA deadline is May 31
The Generic Drug User Fee Amendment (GDUFA) requires sites identified in the production of generic drug products to self-identify each year with the FDA during the annual reporting period, May 1 to May 31.
Products manufactured at sites that do not self-ID will be deemed misbranded.
Self-Identification submissions must be made in Structured Product Labeling (SPL) format and there are several steps you must take before you can make your submission to FDA.
Reed Tech offers complete assistance for GDUFA Self-ID submissions to the FDA. We'll explain what data you need to collect, convert your data to electronic SPL format and submit your information to the FDA for approval and confirmation.
If you have any questions or would like to start preparing for your GDUFA Self-ID submission, please contact us at Pharma@ReedTech.com and we'll be happy to help.