20080827 FDA Draft guidance: ISE

Guidance for Industry
Integrated Summary of Effectiveness
http://www.fda.gov/cder/guidance/7694dft.htm

20080822 EMEA Question and Answer on records of study subject data relating to clinical trials

22/8/08 GCP The GCP IWG has released a Question and Answer on records of study subject data relating to clinical trials.
The GCP IWG receives many queries relating to the documentation of study subjects' participation in clinical trials. This Q and A is the first to be published by the GCP IWG on this topic.

http://www.emea.europa.eu/Inspections/GCPQaA.html

200807 CHMP concept paper: Rev investigation of drug interactions

21/08/08 Concept paper/Recommendation on the need for revision of (CHMP)
Note for guidance on the investigation of drug interactions
http://www.emea.europa.eu/pdfs/human/ewp/29793108en.pdf

200807 CHMP draft guidance: GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE(CHMP)
GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
DRAFT

http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf

200808 FDA draft guidance: ABECB-COPD

Rev.1　ドラフトが出ました（1998の(ドラフト)ガイダンス　
Acute Bacterial Exacerbation of Chronic Bronchitis DevelopingAntimicrobial Drugs for Treatment　に対するもの）
Guidance for Industry
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs forTreatment DRAFT GUIDANCE
http://www.fda.gov/cder/guidance/4511dft.pdf

20080813 MHLW 規制改革会議「中間とりまとめ」に対する厚生労働省の考え方

http://www.mhlw.go.jp/houdou/2008/08/h0812-1.html

20080804 FDA: ICH E2F step2 Guidance for Industry: E2F Development Safety Update Report

http://www.fda.gov/cder/guidance/8413dft.pdf

2008/08/04 Concept Paper on the Development of a Guideline on Pharmaceutical Development of Medicines for Paediatric Use

http://www.emea.europa.eu/pdfs/human/qwp/13893108en.pdf