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Allergenic Product New Data To Be Considered By Cmte. In Reclassification Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Data generated since 1983 reclassification panel report will aid FDA’s Allergenic Products Advisory Committee in determining agency’s position on categories for allergenic products on April 7. Reclassification panel’s recommendations in 1983 to classify most allergenic products as Category I were never implemented by FDA.

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Allergenic Extract Data Search Should Be Broadened, FDA Advisory Committee Says

In addition to medical publications and adverse event reports, FDA should utilize a search engine such as Google "to cast a wider net" over available sources of safety and efficacy data on the roughly 1,200 Category IIIA allergenic products it is seeking to reclassify, the committee says.

Allergenic Extract Data Search Should Be Broadened, FDA Advisory Committee Says

In addition to medical publications and adverse event reports, FDA should utilize a search engine such as Google "to cast a wider net" over available sources of safety and efficacy data on the roughly 1,200 Category IIIA allergenic products it is seeking to reclassify, the committee says.

Allergenic Product Reclassification Will Be Discussed At April 7 Advisory Committee

The committee will assess whether Class IIIA products should remain licensed or be pulled from the market. An update on FDA's "critical path" drug development initiative is also on the agenda.

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