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
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