FDA Guidance for Industry: Changes to an Approved NDA or ANDA, Questions and Answers
Titel:
FDA Guidance for Industry: Changes to an Approved NDA or ANDA, Questions and Answers
Internet:
Herkunft/Verlag:
Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20856, Tel. 301 827 4573, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122871.pdf
Dokumentenart:
Guidance for Industry
Inhalt:
Diese Guidance enthält Fragen und Antworten zu zulassungsrelevanten Änderungen.