-
Vaccines, Blood & Biologics
Approval History, Letters, Reviews, and Related Documents - Ixiaro
Approval information/letter/labeling
-
Memorandum/Reviews
- Categorical exclusion under 21 CFR ยง 25.31(a) and (c)
- Intercell BLA Review Memo
- DPQ Review Memo
- DPQ Comments
- Clinical Review of New Biologics License Application (PDF - 786KB)
- Inspection Waiver Memo
- CMC Review - Ixiaro
- Pharmacovigilance review (PDF - 40KB)
- Cell Substrate Review
- End of Products Cell Bank
- Re-evaluation of proposed proprietary name
- Bioresearch Monitoring Inspection Results - Ixiaro
- Statistical Review and Evaluation - Ixiaro
- Conference Call Between FDA and Intercell
- Review Memorandum - Ixiaro (PDF - 250KB)
-
-
Correspondence
- 2/24/2009 Telecon Summary 2
- 2/24/2009 Telecon Summary 1
- 2/20/2009 Telecon Summary Memo
- 1/16/2009 Telecon
- 12/17/2008 Summary of Teleconference
- 12/5/2008 Email
- 11/24/2008 Email
- 10/10/2008 Record of Telecon
- 8/14/2008 Email
- 7/25/2008 Summary of Teleconference (PDF - 78KB)
- 7/17/2008 Results of Telecon
- 4/28/2008 Summary of Teleconference (PDF - 82KB)
- 3/14/2008 Teleconference Summary
-
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
-
-
-