Zdrowie i gospodarka · 14.08.2006
Guidance for Industry on Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease- Associated and Other Immunoglobulin G (IgG) Antibodies," dated August 2006. The 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. This guidance finalizes the draft guidance entitled "Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin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, and supersedes the draft reviewers' guide entitled "Disease Associated Antibody Collection Program," dated October 1, 1995.