Food and Drug Administration
Anti-Infective Drugs Advisory Committee
February 19, 2002
(Formerly for September 13, 2001)
Approach for selection of delta in Non-inferiority (equivalence) clinical Trials
Briefing Information
Introduction, Dianne Murphy, Renata Albrecht, MD, CDER, FDA pdf htm doc
ICH Harmonised Tripartite Guideline, Statistical Principles for Clinical Trials, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use pdf
August 13, 2001 Memorandum from Daphne Lin, CDER, to Anti-Infective Drugs Advisory Committee Members and Guest Experts pdf htm doc
ICH Harmonised Tripartite Guideline, Choice of Control Group and Related Issues in Clinical Trials pdf
August 13, 2001 Memorandum from Leo Chan, FDA, to Anti-Infective Drugs Advisory Committee Members and Guest Experts regarding Points to Consider pdf htm doc
1992 Points to Consider, Rescinded February 2001 pdf
February 2001 Points to Consider pdf
Points to Consider, Clinical Development and Labeling of Anti-Infective Drugs Products pdf