Transcription of European Medicines Agency
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European Medicines Agency
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 27 July 2006 Doc. Ref. CHMP/EWP/83561/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON CLINICAL TRIALS IN SMALL POPULATIONS DRAFT AGREED BY EFFICACY WORKING PARTY / AD HOC GROUP ON CLINICAL TRIALS IN SMALL POPULATIONS May 2002 January 2005 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION March 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) September 2005 AGREED BY EFFICACY WORKING PARTY July 2006 ADOPTION BY CHMP 27 July 2006 DATE FOR COMING INTO EFFECT 1 February 2007 EMEA 2006 Page 2/10 GUIDELINE ON CLINICAL TRIALS IN SMALL POPULATIONS TABLE OF CONTENTS 1.
factor VIII or IX products. (CPMP BPWG 1561/99). Within-patient comparisons in a relentlessly and predictably progressive disorder might provide sufficient data to support a benefit–risk assessment. However, in other situations comparative trials may be needed/expected.
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