Tuesday, 3 November 2020 14.00 - 15.30 h
All holders of a Drug Master File (DMF) for the US market are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application. In addition, Type II API DMFs must undergo an FDA initial completeness assessment. This assessment is described in the FDA Draft Guideline "Initial Completeness Assessments for Type II API DMFs under GDUFA" which was published in October 2012.
If the DMF passes the initial Completeness Assessment, the DMF number will be made publicly available on FDA’s website. The list of Drug Master Files is now available for download.