20110217 FDA guidance DRAFT: Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies

Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (PDF - 531KB)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243702.pdf

20110216 FDA guidance DRAFT: Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 316KB)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243537.pdf

20110331 FDA guidance: Postmarketing Studies and Clinical Trials

Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 276KB)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf

20110329 PMDA English translation of CTD related notification

March 29, 2011
English translations of Administrative Notices: "Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time", "Points to Consider for Reducing Total Review Time for New Drug Applications"

Notification page:
http://www.pmda.go.jp/english/service/notifications.html