Nonprescription Drugs Advisory Committee

October 20, 2005

Background Package Table of Contents

 

EXECUTIVE SUMMARY

 

TAB 1            Comments from the SDA/CTFA Industry Coalition Regarding the Benefit and Efficacy of
Consumer Antiseptics (75N-183H; CP16)

TAB 2            Excerpt of Comments from the SDA/CTFA Industry Coalition Regarding the Benefit and
Efficacy of Consumer Antiseptic Handwashes (75N-183H; C12, volume 1)

TAB 3            Excerpt of Comments from the SDA/CTFA Industry Coalition Regarding the Benefit and
Efficacy of Consumer Antiseptic Bodywashes (75N-183H; C12, volume 1)

TAB 4            Excerpt of Comments from the SDA/CTFA Industry Coalition Regarding the Impact of the
1994 TFM on Public Health and Industry (75N-183H; C12, volume 1)

TAB 5            FDA Reviewer’s Evaluation of the SDA/CTFA Submission (CP16) Regarding Benefit and
Efficacy of Consumer Antiseptics

TAB 6            FDA Reviewer’s Evaluation of the SDA/CTFA Submissions (C12, CP7, CP16) Regarding
Benefit of Antiseptic Bodywashes

TAB 7            FDA Reviewer’s Literature Survey to Determine the Clinical Benefit of Consumer Antiseptics

TAB 8            Recommendations of the Council on Scientific Affairs for the American Medical Association
on Consumer Antiseptic Products

TAB 9            Comments from the SDA/CTFA Industry Coalition Regarding the Development of
Antimicrobial Resistance (75N-183H; C84)

TAB 10           Background Information on Biocide Resistance Mechanisms

TAB 11          FDA Reviewer’s Literature Survey Regarding Antibiotic and Biocide Cross-Resistance

TAB 12          FDA Reviewer’s Literature Summary Regarding Potential Environmental Hazards of Biocides

TAB 13           Background Information on the Hygiene Hypothesis

TAB 14           The Monograph versus New Drug Application Process

TAB 15          Federal Register Notice: Tentative Final Monograph for OTC Healthcare Antiseptic
Drug Products – June 17, 1994