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Classification panel

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  1. Reclassification of IIIA allergenic products part of preread materials for Allergenic Products Advisory Committee. 2005

  2. Classification panel • Convened under 21 CFR 601.25: “For purposes of reviewing biological products that have been licensed prior to July 1, 1972 that they are safe and effective and not misbranded…” • Data requested from manufacturers in 39 FR 1082 (4 January 1974) and 39 FR 21176 (12 June 1974) • Panel met from 24 May 1974 through 11 August 1979 • Panel report: submitted 13 March 1981; published in 50 FR 3082-3288 (23 January 1985)

  3. The Panel’s Task Classification panel 1974-1979 (601.25) • >1,500 extracted substances reviewed • Goals: • Evaluate safety and efficacy in accordance with 601.25 • Review labeling • Submit report on conclusions and recommendations

  4. Product Classification CategoriesDefined in 21 CFR 601.25 • Category I: safe; effective; and not misbranded • Category II: unsafe; ineffective; or misbranded • Category III: data insufficient for classification • IIIA: thought to have favorable risk-benefit ratio; remain on the market pending completion of testing • IIIB: thought to have unfavorable risk-benefit ratio; removal from the market pending completion of testing

  5. Reclassification panel • Convened under 21 CFR 601.26: IIIA products to be reclassified as I or II • Panel met from 19 November 1982 to 4 June 1983 • Panel report submitted December 1983

  6. Panel Recommendations (diagnosis)Reclassification panel 1982-1983 (601.26) • All Category IIIA products recommended for reclassification into Category I for diagnosis except: • Certain pollens, molds, avian/mammalian, inhalants were recommended for reclassification as Category II • Panel stated that species definition required for reclassification into Category I

  7. Panel Recommendations (therapy)Reclassification panel 1982-1983 (601.26) • Pollen extracts, mammalian/avian extracts, many mold and insect extracts recommended for reclassification into Category I • Species definition was required for reclassification into Category I • Miscellaneous inhalant and all food extracts recommended for reclassification into Category II

  8. Task at hand: 2003-2006 • Review the 601.26 Reclassification Panel’s recommendations regarding Category IIIA products • Review data published since 1972 • Determine FDA position on Reclassification Panel’s recommendations based upon additional data