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

20100928 FDA 21CFR part312 IND Safety Reporting Requirements

Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (PDF - 163KB)1 (Final Rule)
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies (Draft) (PDF - 688KB)
Federal Register Notice: Availability of Draft Guidance (PDF - 50KB)3
FDA Press Release4 (9/28/2010)
Q & A: Final Rule - New Safety Reporting Requirements for Investigational New Drug Applications (INDs)

20100928 FDA Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies

20110117 MHLW 新医薬品の総審査期間短縮に向けた申請に係るCTDのフォーマットについて

医薬食品局 新着の通知

平成２３年１月１９日掲載


* 新医薬品の総審査期間短縮に向けた申請に係るCTDのフォーマットについて（平成23年１月17日　事務連絡）(PDF,236KB)【医薬食品局審査管理課　薬事法関係】

http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/T110119I0010.pdf

20110106 FDA draft guidance "Electronic Source Documentation in Clinical Investigations"

Electronic Source Documentation in Clinical Investigations
DRAFT GUIDANCE

TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. ELECTRONIC SOURCE DOCUMENTS AND SOURCE DATA
A. Tier 1 - Data Entry
1. Data Elements
2. Data Element Attributes and Data Element Identifiers
3. Modifications and Corrections
4. Repeated Appearance of the Same Data Element in an eCRF
5. Electronic Prompts to Ensure Accuracy and Completeness of Data
6. Originators of Data Elements
7. Identification of Data Originators
B. Tier 2 – Data Review
1. The Investigator
2. The Investigator’s Copy of the eCRF
C. Tier 3 -- Data Processing and Transmission
IV. REGULATORY REVIEW COLLABORATION
GLOSSARY OF TERMS

20110112 European Medicines Agency opens public discussion on need for active control in clinical trials

reflection paper
http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500100710&murl=menus/news_and_events/news_and_events.jsp&mid=0b01ac058009a3dc