FDA Guidance for Industry CMC Postapproval Manufacturing Changes to be documented in Annual Reports
Titel:
FDA Guidance for Industry
CMC Postapproval Manufacturing Changes to be documented in Annual Reports
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf
Inhalt:
Empfehlungen an Zulassungsinhaber zu den Typen von Änderungen welche im Annual Report vorkommen