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Guidance on Immunoglobulin Antibody Collection

10/20/2005

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies. The draft will assist source plasma manufacturers in submitting to FDA the appropriate information when implementing an IgG antibody collection program or when adding a new IgG antibody collection to an existing program. When finalized, the document would supersede the draft reviewers' guide entitled Disease Associated Antibody Collection Program, dated 10/1/95. To download this guidance, click here. To view this notice, click here.

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