U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
October 15, 2002
FDA Workshop on the Notification Process for Food Contact Substances
Toxicology Guidance
October 15, 2002
Begin Presentation
Author:
Carolyn Young, Ph.D.
Table of Contents
Food Contact Notifications Stakeholders Meeting
Stakeholders Meeting
Toxicology Guidance
Toxicology Guidance Document
Information for FDA-Regulated Industry
Information for FDA-Regulated Industry
Information for FDA-Regulated Industry
Food and Color Additives Publications
Guidance for Industry
Toxicology - Guidance
Toxicology Guidance
Toxicology Guidance
Toxicology Guidance
Toxicology Guidance
Toxicology Guidance
IV. Safety Testing Recommendations for FCS and Constituents
IV. Safety Testing Recommendations for FCS and Constituents
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
IV. Safety Testing Recommendations for FCS and Constituents (cont.)
V. Organization of the Safety Information
VI. Safety Narrative
VI. Safety Narrative (cont.)
VI. Safety Narrative (cont.)
Summary for Decision of Safety
VII. Comprehensive Toxicological Profile (CTP)
VII. Comprehensive Toxicological Profile (cont.)
CTP
FCN 101
Common Deficiencies
FCN Deficiencies
FCN -Toxicology Deficiencies & Problems
FCN Submission
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
FCN Submission
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Common Deficiencies/Problems
Conclusions
Acceptable FCN
Acceptable FCN
Acceptable FCN
Acceptable FCN
Toxicology Guidance
Toxicology Guidance
Epilogue
FCN Submission
FCN Submission
FCN Submission
FCN Workshop Agenda & Presentations
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