20071030 Reflection Paper on Methodological Issues in Confirmatory Clinical Trials planned with an adaptive design

REFLECTION PAPER ON METHODOLOGICAL ISSUES IN CONFIRMATORYCLINICAL TRIALS WITH FLEXIBLE DESIGN AND ANALYSIS PLAN

http://www.emea.europa.eu/pdfs/human/ewp/245902enadopted

20071026 FDA DRAFT Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility

Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility[PDF version (73 KB)]
DRAFT GUIDANCE

20071029 EMEA Public Statement - Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and ...

29/10/07 Public Statement - Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease

20071026 MHLW GCP related call for public comment

「医薬品の臨床試験の実施の基準に関する省令等の一部改正（案）」に関する意見の募集について
http://search.e-gov.go.jp/servlet/Public?CLASSNAME=Pcm1010&BID=495070154&OBJCD=&GROUP=

「治験計画の届出及び治験中の安全性情報の規制当局への報告に係る薬事法施行規則等の一部改正（案）」に関する意見の募集
http://search.e-gov.go.jp/servlet/Public?CLASSNAME=Pcm1010&BID=495070155&OBJCD=&GROUP=

20071025 Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation DRAFT

20070920 EMEA PTSD guidance draft

FDA draft Guidance for Industry Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval