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
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

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