EMEA: Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg)
25.03.2009
EMEA:
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline.
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance covers biological data, clinical trials and patient follow-up. Quality aspects are outside the scope of this guideline.
The source of the news: http://www.emea.europa.eu/pdfs/human/bpwg/038895endraft.pdf
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