Table of Contents
Summary of Issues on Urticaria as an OTC Indication
Safety Criteria for OTC Drugs
Observations
Urticaria (hives) as an OTC Use
Urticaria (hives) as an OTC Use
Sponsor Proposal for an OTC Urticaria Indication
Other “Studies”: Consumer and Physician Surveys
Sponsor Proposal: Limit to CIU Population
Prior Experience with Restriction to Physician Diagnosed Population
Problems with this Approach
Issues for the Committee
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Author: CDER USER
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