20071127 EMEA Reflection Paper on pharmacogenomic samples, testing and data handling

27/11/07 Reflection Paper on pharmacogenomic samples, testing and data handling http://www.emea.europa.eu/pdfs/human/pharmacogenetics/20191406en.pdf

FDA-EMEA cooperation intensified

http://www.emea.europa.eu/pdfs/general/direct/pr/55739107en.pdf

COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION
http://www.emea.europa.eu/pdfs/human/comp/EMEAFDA_Application_Form_for_Orphan_Medicinal_Product_Designation.doc

20071121 FDA DRAFT Guidance for Industry: Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention

Guidance for Industry: Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention [PDF]
http://www.fda.gov/cder/guidance/7423dft.pdf

20071107 EMEA Reflection Paper on the use of Genomics in Cardiovascular Clinical Trials

21/11/07 Reflection Paper on the use of Genomics in Cardiovascular Clinical Trials
http://www.emea.europa.eu/pdfs/human/pharmacogenetics/27878906enfin.pdf

「医薬品評価におけるファーマコゲノミクスの利用に関する現状と課題に関する報告書」 について

「医薬品評価におけるファーマコゲノミクスの利用に関する現状と課題に関する報告書」 について
http://www.pmda.go.jp/topics/h191113kohyo.html
http://www.pmda.go.jp/topics/file/h191113kohyo.pdf

FDA DRAFT GUIDANCE: Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment

COPD guidance draft
http://www.fda.gov/cder/guidance/7875dft.htm

JPMA 「臨床試験データの電子的取得に関するガイダンス」

http://www.jpma.or.jp/about_info/policy/clinical.html