FDA Guidance for Industry: Changes to an Approved NDA or ANDA, Revision 1
Titel:
FDA Guidance for Industry: Changes to an Approved NDA or ANDA, Revision 1
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/ucm077097.pdf
Dokumentenart:
FDA Guidance for Industry
Inhalt:
Diese FDA Guideline enthält wichtige Hinweise für Zulassungsänderungen (Changes).