FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 December 1, 2003 Dear Manufacturer, Please refer to the October 16, 2003 letter regarding your Immune Globulin Intravenous (Human) (IGIV) in which FDA required updates to your product labeling. This letter is notification that FDA is extending the deadline for the submission of the CBE required in that letter by an additional 45 days. The due date to submit this supplement to your Biologics License is January 14, 2004. Please indicate in the cover letter of the supplement the date by which you expect to implement the changes. If you have any questions concerning this letter, please contact Michael Wiack of the Division of Blood Applications, at 301-827-3524. Sincerely yours, --- signature --- Basil Golding, M.D. Director Division of Hematology Office of Blood Research and Review Center for Biologics Evaluation and Research

Updated December 15, 2003

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page FDA / Center for Biologics Evaluation and Research