FDA Guidance for Industry: M2 eCTD Specification Questions and Answers and Change Requests
Titel:
FDA Guidance for Industry: M2 eCTD Specification Questions and Answers and Change Requests
Internet:
Herkunft/Verlag:
Center for Biologics Evaluation and Research (CBER) Food and Drug Administration 1401 Rockville Pike, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073244.pdf Rockville, MD 20852-1448
Dokumentenart:
Leitfaden für die Industrie
Inhalt:
Leitfaden für Antragsteller, im Frage und Antwort Stil, zum Gebrauch des "Electronic Common Document.