EMEA clinical evaluation guidances

27/07/07
Guideline on Clinical investigation of immunosupressants for solid organ transplantation
27/07/07
Guideline on the Development of New Products for the Treatment of Nicotine Dependence
27/07/07
The need for revision of the Guideline on Clinical Investigation of Hypnotic Medicinal Products
27/07/07
Guideline on the Evaluation of Medicinal Products for Cardiovascular Disease Prevention
27/07/07
Guideline on Medicinal Products for the Treatment of Alzheimer's Disease and other Dementias
27/07/07
Guideline on Clinical Investigation of Medicinal Products in the Treatment of Parkinson's Disease

EMEA Paediatric population Pharmacovigilance

04/07/07
Overview of comments received on draft Guideline on conduct of Pharmacovigilance for medicines used by the paediatric population

EMEA Population PK

06/07/07
Guideline on Reporting the Results of Population Pharmacokinetic AnalysesOverview of comments received on the draft Guideline on Reporting the Results of Population Pharmacokinetic Analyses

FDA (DRAFT) Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [HTML] or [PDF]

20070625 Piroxicam in Europe

25/06/07
Press Release European Medicines Agency recommends restricted use for Piroxicam
25/06/07
Questions and Answes on the review of Piroxicam

20070612 EMEA PGx related

12/06/07
Overview of comments received on draft Reflection Paper on the use of Pharmacogenetics in the Pharmacokinetic Evaluation of Medicinal Products
12/06/07
Reflection Paper on the use of Pharmacogenetics in the Pharmacokinetic Evaluation of Medicinal Products

200705 FDA guidances

Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics [PDF]

Guidance for Industry: Computerized Systems Used in Clinical Trials [HTML] or [PDF]

2007/04/24 EMEA: Final report from the EMEA/CHMP-think-tank group on innovative drug development

20070510 FDA Computerized Systems Used in Clinical Trials

20070330 PMDA 治験相談手数料の改正に関する意見募集の実施結果について

独立行政法人医薬品医療機器総合機構審査等業務関係業務方法書実施細則に規定する医薬品の治験相談手数料の改正に関する意見募集の実施結果について
http://www.pmda.go.jp/public/pubcome_iyaku20070330.html

独立行政法人医薬品医療機器総合機構審査等業務関係業務方法書実施細則に規定する医療機器及び体外診断用医薬品の治験相談等に係る新区分の設定に伴う手数料の設定に関する意見募集の実施結果について 日本薬局方収載原案に関する意見の募集について
http://www.pmda.go.jp/public/pubcome_kiki20070330.html