20080925 FDA DRAFT Guidance for Industry: End-of-Phase 2A Meetings

Guidance for Industry: End-of-Phase 2A Meetings [PDF] or [HTML]

INTRODUCTION
BACKGROUND
Strategies for Early Dose Selection
EOP2A Pilot Program
The EOP2A Meeting
Objectives of an EOP2A Meeting
EOP2A Meeting Requests
Useful Information for an EOP2A Meeting Package
EOP2A Meeting Arrangements
http://www.fda.gov/cder/guidance/8297dft.htm

20080912 MHLW「ICH E2F：開発時定期的安全性最新報告（案）」について

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=Pcm1050&BID=495080134&cmbKENSU=10&rdoSEARCH1=0&txtKeyword=&rdoSEARCH2=0&rdoSEARCH3=0&rdoSEARCH4=0&cmbYERST=&txtMonST=&txtDayST=&cmbYERED=&txtMonED=&txtDayED=&chkFUSHO=0000000033&hdnParentsCLS=Pcm1050&hdnBsSort=0&hdnKsSort=0&hdnDispST=11&OBJCD=&GROUP=

20080908 FDA Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases

Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases - 9/8/2008

http://www.fda.gov/cber/gdlns/gidvacc.htm

http://www.fda.gov/cber/gdlns/gidvacc.pdf

20080909 FDA Guidance for Industry: Concept Papers Animal Models — Essential Elements to Address Efficacy Under the Animal Rule

Guidance for Industry: Concept Papers Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF]
http://www.fda.gov/cder/guidance/8324concept.pdf

20080908 治験薬ＧＭＰの改正に関する意見募集の結果について

治験薬ＧＭＰの改正に関する意見募集の結果について

http://search.e-gov.go.jp/servlet/Public?ANKEN_TYPE=3&CLASSNAME=Pcm1020&KID=495070200&OBJCD=&GROUP=&cmbKENSU=10&rdoSEARCH1=0&txtKeyword=&rdoSEARCH2=0&rdoSEARCH3=0&rdoSEARCH4=0&cmbYERST=&txtMonST=&txtDayST=&cmbYERED=&txtMonED=&txtDayED=&chkFUSHO=0000000033&hdnParentsCLS=Pc1020&hdnBsSort=&hdnKsSort=0&hdnDispST=1

20080908 日本学術会議 今後のライフサイエンス・ヘルスサイエンスのグランドデザイン

平成２０年（２００８年）８月２８日
日本学術会議
基礎医学委員会・臨床医学委員会合同
基礎・臨床医学研究グランドデザイン検討分科会
今後のライフサイエンス・ヘルスサイエンスのグランドデザイン

http://www.scj.go.jp/ja/info/kohyo/pdf/kohyo-20-h62-4.pdf

20080904 EMEA guidances: antiarrhytmic, Alzheimer's Disease, Parkinson's Disease

04/09/08
Note for guidance on antiarrhytmics
04/09/08
Press Release - EMEA releases guidelines on development of medicines for Alzheimer's disease and Parkinson's disease
04/09/08
Clinical Investigation of Medicinal Products in the Treatment of Parkinson's Disease (Rev. 1) - See also: Overview of Comments
04/09/08
Guideline on Medicinal Products for the Treatment of Alzheimer's Disease and other Dementias (Rev. 1)

20080903 FDA ICH M3(R2)

Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [PDF]

20080903 EMEA several guidelines

03/09/08
Guideline on clinical evaluation of medicinal products used in weight control (CPMP/EWP/281/96 rev. 1) addendum on weight control in children

03/09/08
Overview of comments received on draft guideline on clinical evaluation of medicinal products used in weight control addendum on weight control in children

03/09/08
Guideline on the development of new medicinal products for the treatment of crohn’s disease

03/09/08
Guideline on clinical investigation of immunosuppressants for solid organ transplantation

03/09/08
Overview of comments received on draft guideline on clinical investigation of immunosupressants for solid organ transplantation