GDUFA

Attention Generic Drug Manufacturers (and pharma labeling enthusiasts who want to learn more):

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 June 1. Products manufactured at sites that do not self-identify will be deemed misbranded. These submissions need to be made in Structured Product Labeling (SPL) format. 

Leading up to this June 1, 2023 deadline, Reed Tech subject-matter expert, Gary Saner, presented a webinar reviewing the GDUFA requirement and deadline. Gary is the chair of the SPL Technical Team with over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry.

View the Recording  Now of the webinar, Upskill with Reed Tech: GDUFA!

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For more information: Pharma@ReedTech.com, +1-215-557-3010