International Activities
Federal Register Notices of Draft and Final Guidance Availability (7/1/00 to the present)

• 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• Draft Guidance for Industry on Submitting Marketing Applications According to the ICH/CTD Format; General Considerations; Availability.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  • The Draft Guidance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) 

  • The Guidance

• 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