Tag Archive
The following is a list of all entries tagged with human varicella immunoglobulin:
Drug Regulators Publish Concept Paper on Clinical Investigation of Specific Immunoglobulins
Filed in EMEA,clinical,regulatory, September 29, 2009, 3:01 pmno guideline on the clinical investigation of these human specific immunoglobulins is currently available. As the regulatory experience from the marketing authorisation applications, especially for human plasma-derived hepatitis Bimmunoglobulin has been developing during the past decades, the development of a guideline appears appropriate
Drug Regulators Publish Concept Paper on Clinical Investigations of Specific Immunoglobulins
Filed in biotechnology,clinical,regulatory, August 25, 2009, 11:17 amDue to the recent increase of submission of marketing authorisation applications for human plasma-derived hepatitis B immunoglobulin (HBIG), several questions regarding the required clinical data arise. Furthermore, compliance to the current available Core SmPC being recommended, a specific guidance relating to the clinical investigation of HBIG products appears appropriate. The expansion of this NfG to all specific immunoglobulins needs to be considered.
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