Prilosec 1 Label Comprehension Studies 02255 and12179

6/25/02


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Table of Contents

Prilosec 1 Label Comprehension Studies 02255 and12179

Overview

21 CFR 330.10 (a) (4) (v)

Study 02255: Participants

Study 02255--Product Purpose

Study 02255--Episodic Use

Study 02255--Self-Selection

Study 02255--Self-Selection: Those who should not use or should consult MD

Study 02255--Applying the Label to Self and Others

Conclusion--Study 02255

Conclusion--Study 02255

More Data Needed

Study 12179: Purpose

Study 12179: Participants

Study 12179: Label

Study 12179: Agency Analysis of Self-Selection Question

Study 12179: Scoring Differences with Sponsor

Study 12179: Agency Analysis of Self-Selection Results

Study 12179: Product Purpose

Study 12179: Applying the Label to Other People

Label Changes after Label Comprehension Studies

Conclusions: Studies 02255 and 12179

Conclusions: Studies 02255 and 12179

Conclusions

Author: CDER USER