U.S. Food and Drug Administration Center for Drug Evaluation and Research
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International Conference on Harmonisation; Guidance on Q1A Stability Testing of New Drug Substances and Products; Availability Optional format: PDF (Issued 11/7/2001, Posted 11/15/2001)
The Guidance
Published October 16th - International Conference on Harmonisation; Guidance on M4 Common Technical Document; Availability (Posted 10/17/2001)
The Guidance M4: Organization of the CTD M4E: The CTD-Efficacy M4Q The CTD-Quality M4S: The CTD-Safety M4S: The CTD-Safety Appendices
Draft Guidance for Industry on Submitting Marketing Applications According to the ICH/CTD Format; General Considerations; Availability. Optional format: PDF. Comments by November 5, 2001. (Issued and posted 9/5/2001)
The Draft Guidance
International Conference on Harmonisation; Guidance on S7A Safety Pharmacology Studies for Human Pharmaceuticals; Availability. Optional format: PDF (Issued and posted 7/13/01)
International Conference on Harmonisation; E10 Choice of Control Group and Related Issues in Clinical Trials. Optional format: PDF (Issued 5/14/01, Posted 5/16/01)
The Guidance (Issued 5/2001, Posted 5/11/2001)
International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Optional format: PDF. Issued 12/29/00. Submit written comments by March 29, 2001.
Q3B(R) Impurities in New Drug Products. Optional format: PDF. Issued 7/19/00.
Q3A(R) Impurities in New Drug Substances. Optional format: PDF. Issued 7/20/00.
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs. Optional format: PDF. Issued 8/9/00
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FDA/Center for Drug Evaluation and Research Last Updated: January 10, 2002 Originator: OTCOM/DLIS HTML by SJW