Source

Title

Issue Date

ICH

Guideline for Good Clinical Practice

June1996

ICH

Structure and Content of Clinical Study Reports

July 1996

ICH

Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data

June 1998

ICH

Guidance on Statistical Principles for Clinical Trials

Sept 1998

FDA

General Considerations for the Clinical Evaluation of Drugs

Feb 1997

FDA

Conducting a Clinical Safety Review of a New Product Application and Prep a Report on the Review

June 2005

FDA

FDA Forms Distribution Page for CDER (including Assoc Forms)

June 2005

FDA

Binders (IND, NDA, ANDA, DMF)

April 1998

21CFR314

Applications for FDA Approval to Market a New Drug

April 2001

21CFR312

Investigational New Drug Application

April 2004

21CFR56

Institutional Review Boards

April 2004

21CFR50

Protection of Human Subjects

April 2004

21CFR11

Electronic Records; Electronic Signatures

April 2004

21CFR54

Financial Disclosure by Clinical Investigators

April 2004

SFDA

Regulations for Drug Registration

2003