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FDA draft Guidance for Industry Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval

20070919 「治験のあり方に関する検討会」報告書について

2007eCTDの国内 eCTD お問い合わせ・不具合事例

EMEA Overview of comments received on the draft guideline "Requirements for first-in-man clinical trials for potential high-risk medicinal products"

23/08/07
Overview of comments received on the draft guideline "Requirements for first-in-man clinical trials for potential high-risk medicinal products"

EMEA first-in-human clinical trials

26/07/07
Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products

EMEA first-in-human clinical trials

26/07/07
Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal productsh