Responsibilities for the Completeness Assessment under GDUFA, cont.
The responsibilities of CDER’s Office of Generic Drugs with respect to Type II API DMFs under GDUFA include:
- Performing a timely Completeness Assessment
- Issuing comments for DMFs found “Incomplete”
- Publishing a list of DMFs found “available for reference” on an FDA Web site
- Publishing criteria for the Completeness Assessment
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