FDA Guidance for Industry: M4: The CTD - Efficacy Questions and Answers
Titel:
FDA Guidance for Industry: M4: The CTD - Efficacy Questions and Answers
Internet:
Herkunft/Verlag:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073293.pdf
Dokumentenart:
Guidance
Inhalt:
In dieser Richtlinie werden ausschließlich Fragen zum Thema Wirksamkeit im Rahmen einer Arzneimittelzulassung beantwortet.