Particulates in allergen extracts

4/5/02


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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

Author: CBER