FDA Guidance for Industry: Completeness Assessments for Type II API DMFs under GDUFA
Titel:
FDA Guidance for Industry: Completeness Assessments for Type II API DMFs under GDUFA
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321884.pdf
Inhalt:
This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).