GDUFA Self-Identification Assistance
The Generic Drug User Fee Amendments (GDUFA) mandate an annual self-identification process for drug facilities, sites, and organizations involved in generic drug submissions.
This process requires these entities to provide detailed information about their identity to the FDA between May 1 and June 1 each year.
Masuu US Agent offers comprehensive support for GDUFA self-identification, including assistance with obtaining FEI and DUNS numbers and providing technical support for SPL or XML conversion.
Our services guide pharmaceutical companies through every step of the self-identification process, ensuring compliance with FDA requirements.