Zdrowie i gospodarka · 20.10.2005

Draft Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin Antibodies; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies," dated October 2005. The draft guidance document is intended to assist source plasma manufacturers in submitting to FDA the appropriate information when implementing an IgG antibody collection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. The draft guidance, when finalized, would supersede the draft reviewers' guide entitled "Disease Associated Antibody Collection Program," dated October 1, 1995.