Allergenic Extract Data Search Parameters Should Be Widened, Cmte. Says
Executive Summary
FDA should expand its data search boundaries for the reclassification of allergenic extracts, its Allergenic Products Advisory Committee said
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Allergenic Products Advisory Committee meeting
A proposed strategy for the reclassification of Category IIIA allergenic products - those for which data are insufficient for classification but which are thought to have a favorable risk-benefit ratio and should remain on the market pending completion of testing - will be discussed at the Sept. 13 meeting of FDA's Allergenic Products Advisory Committee. In its 2005 meeting, the committee had advised FDA to expand its data search boundaries for the reclassification of Category IIIA allergenic extracts (1"The Pink Sheet" April 11, 2005, p. 36). The meeting, to be held at the National Institutes of Health, Bethesda, Md. from noon to 3:45 p.m., will include an update of CBER's Laboratory of Immunobiochemistry's research program on parasitic and allergenic products...
Allergenic Products Advisory Committee meeting
A proposed strategy for the reclassification of Category IIIA allergenic products - those for which data are insufficient for classification but which are thought to have a favorable risk-benefit ratio and should remain on the market pending completion of testing - will be discussed at the Sept. 13 meeting of FDA's Allergenic Products Advisory Committee. In its 2005 meeting, the committee had advised FDA to expand its data search boundaries for the reclassification of Category IIIA allergenic extracts (1"The Pink Sheet" April 11, 2005, p. 36). The meeting, to be held at the National Institutes of Health, Bethesda, Md. from noon to 3:45 p.m., will include an update of CBER's Laboratory of Immunobiochemistry's research program on parasitic and allergenic products...
CATEGORY IIIB ALLERGENIC EXTRACTS LICENSES BEING REVOKED BY FDA
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.