Table of Contents
Particulates in allergen extracts
Historical Perspective
PPT Slide
PPT Slide
How Did Precipitate Issue Arise?
Precipitated SRW Extract
Precipitated SRW Extract
Current Knowledge
PPT Slide
Current Regulatory Position
Dosage and Administration section [21 CFR 201.57 (j)] :
Recommended additions to “Description,” “Warnings,” and “Dosage and Administration” :
Summary
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Author: CBER
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