Guideline: Changes to an Approved NDA or ANDA, Questions and Answers
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| Titel: | Changes to an Approved NDA or ANDA, Questions and Answers |
| Internet: | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122871.pdf |
| 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 |
| Inhalt: | Diese Guidance enthält Fragen und Antworten zu zulassungsrelevanten Änderungen. |
| Dokumentenart: | Guidance for Industry |
