1 / 8

Classification panel

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

loe
Download Presentation

Classification panel

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related