Generic Drug User Fee Amendments (GDUFA) Self Identification Services
The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that human generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA. This information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs, setting annual facility fee amounts, and targeting inspections.
Who Is Required to Self-Identify?The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA:
Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).
Catain can provide GDUFA Self-Identification services at just $250. There are no additional FDA charges for registration.
Click here ==> GDUFA Self-Identification Form
If you have questions, please get in touch.