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Guidance Issuing OfficeCenter 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 This guidance finalizes the draft guidance entitled “Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 2005D-0362.