FDA Guidance for Industry: M4E(R2): The CTD – Efficacy
Titel:
FDA Guidance for Industry: M4E(R2): The CTD – Efficacy
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM465221.pdf
Inhalt:
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures.