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Executive Summary

CATEGORY IIIB ALLERGENIC EXTRACTS LICENSES BEING REVOKED BY FDA via a Nov. 16 Federal Register notice. The notice comes almost a decade after FDA classified approximately 280 generic allergens as Category IIIB, designating "those products with insufficient data and an unfavorable benefit-to-risk potential which the [Panel on Review of Allergenic Extracts] believed should not continue to be marketed during the development of data to resolve whatever safety and effectiveness questions exist." The Nov. 16 notice revokes the licenses for all Category IIIB products for which no sponsors have requested a hearing.

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