Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies Guidance for Industry August 2006

GUIDANCE DOCUMENT

• Docket Number: 2005D-0362
• Issued by: Center for Biologics Evaluation and Research

Source Plasma manufacturers might want to implement a collection program to collect Source Plasma from donors who have detectable levels of disease-associated Immunoglobulin G (IgG) antibodies and other existing IgG antibodies (see section IV). Such disease-associated IgG antibodies are antibodies that have occurred in response to exposure to disease agents or other antigens. This guidance is intended to assist you, a Source Plasma manufacturer, in submitting the appropriate information to FDA when implementing an IgG antibody collection program or when adding a new IgG antibody collection to your existing program. This guidance finalizes the draft guidance entitled “Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies” dated October 2005 (70 FR 61135; October 20, 2005), and replaces the draft Reviewers’ Guide, “Disease Associated Antibody Collection Program,” issued October 1, 1995.

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