Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - GLASSIA
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Memorandum/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Final Review, Original BLA, Assigned CMC Topics (Stability, QC Assays) - GLASSIA (PDF - 102KB)Immunogenicity Assay Development Memo - GLASSIA, March 22, 2010 Table 42-1 List of Non Active Raw Materials Used in the Kamada-API Purification Process - GLASSIA (PDF - 144KB)Final CMC Review: Original BLA – Sterility, Pyrogen, Bacterial Endotoxin, General Safety Testing - GLASSIA (PDF - 62KB)Clinical Pharmacology Review - GLASSIA (PDF - 156KB)Clinical Pharmacology Review (2) - GLASSIA (PDF - 156KB)Clinical Issues Document - GLASSIA (PDF - 69KB)CMC Midcycle Review Memo Data Appendix - GLASSIA (PDF - 648KB)Manufacturers [Kamada-API] - GLASSIA (PDF - 676KB)Filing Appendix - GLASSIA (PDF - 173KB)Mid-Cycle Review of the BLA Memorandum - GLASSIA, October 20, 2009 (PDF - 35KB)BLA STN: 125325 Kamada-API [Alpha 1 Proteinase Inhibitor (Human) Intravenous] - GLASSIA, June 18, 2010 (PDF - 34KB)Nonclinical Pharm-Tox Review - GLASSIA (PDF - 145KB)MIE-Cycle Statistical Review and Evaluation - GLASSIA (PDF - 213KB)Concurrent Testing Template Letter - GLASSIA (PDF - 25KB)Medical Filing Review Memorandum of Original BLA - GLASSIA (PDF - 85KB)Filing Memo: Chronic Augmentation and Maintenance Therapy in Individuals with Congenital Deficiency of Alpha-1 Proteinase Inhibitor (A1-PI) and Clinical Evidence of Emphysema, July 13, 2009 (PDF - 109KB)PNA Letter - GLASSIA MAA Letter - GLASSIA - PNR Unacceptable Letter - GLASSIA
BLA Filing Letter - GLASSIA Clinical Pharmacology Filing Memo - GLASSIA, July 31, 2009 (PDF - 34KB)Final Review Memo - GLASSIA, June 30, 2010 (PDF - 122KB)Viral Safety and Validation Final Memo - GLASSIA (PDF - 34KB)Medical Final Review Memorandum of Original BLA - GLASSIA, July 1, 2010 (PDF - 645KB)Final Review Memo: Recommend Approval - GLASSIA, July 1, 2010 (PDF - 441KB)Finalization Update Meeting for Kamada Alpha-1-Proteinase Inhibitor (Human) - GLASSIA, June 16, 2010 (PDF - 20KB)Kamada Final Memo - GLASSIA, June 8, 2010 Review Memo - GLASSIA, May 27, 2010 (PDF - 33KB)Bioresearch Monitoring Inspection Results - GLASSIA, May 27, 2010 (PDF - 16KB)Review of Reply to IR: Immunogenicity Assay Development, Quantitation of Filaments in Final Product - GLASSIA, May 14, 2010 (PDF - 54KB)Mid-Cycle Review Memo - GLASSIA, April 1, 2010 (PDF - 95KB)Product: Alpha-1 Proteinase Inhibitor (Human) Intravenous for Chronic Augmentation and Maintenance Therapy in Individuals A1PI Deficiency and Emphysema - GLAASIA, March 22, 2010 (PDF - 59KB)Major Amendment 16 - GLASSIA, March 15, 2010 Final Nonclinical Pharm-Tox Review - GLASSIA, March 5, 2010 (PDF - 116KB)Final Review Memorandum - GLASSIA, March 3, 2010 (PDF - 29KB)Immunogenicity Assay Development - GLASSIA, January 12, 2010 (PDF - 26KB)Filing Meeting Summary on Kamada Alpha-1-Proteinase Inhibitor (Human) - GLASSIA, July 13, 2009 Midcycle CMC Review: Original BLA - GLASSIA, November 25, 2009 (PDF - 68KB)Mid-Cycle Review Viral Validation - GLASSIA, November 23, 2009 (PDF - 134KB)Mid-cycle Review (Viral Validation) - GLASSIA, November 23, 2009 (PDF - 144KB)Review of Original BLA - GLASSIA, November 17, 2009 (PDF - 101KB)Review of Original BLA - GLASSIA, November 17, 2009 (PDF - 101KB)Mid-Cycle Meeting on Kamada Alpha-1-Proteinase Inhibitor (Human) - GLASSIA, October 29, 2009 Midcycle Review, Original BLA - GLASSIA, October 27, 2009 (PDF - 51KB)Bioresearch Monitoring Midcycle Review Memo - GLASSIA, October 23, 2009 (PDF - 17KB)Mid-cycle Memo: Chronic Augmentation and Maintenance Therapy in Individuals With Congenital Deficiency of Alpha-1 Proteinase Inhibitor (A1-PI) and Clinical Evidence of Emphysema - GLASSIA, October 16, 2009 (PDF - 69KB)First Committee Meeting on Kamada Alpha-1-Proteinase Inhibitor (Human) - GLASSIA, June 22, 2009 Statistical Review and Evaluation BLA - GLASSIA, June 1, 2009 (PDF - 159KB)Medical Mid-Cycle Review Memorandum of Original BLA - GLASSIA, May 29, 2009 (PDF - 499KB)
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Correspondence
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Bioresearch Monitoring Inspection Results - GLASSIA, June 28, 2010 (PDF - 20KB)Record of Telephone Conversation - GLASSIA, June 24, 2010 Information Request Email - GLASSIA, June 23, 2010 (PDF - 51KB)Information Request Email - GLASSIA, June 18, 2010 (PDF - 27KB)OOS Investigation for Kamada Alpha-1-Proteinase Inhibitor (Human) - GLASSIA, June 14, 2010 (PDF - 17KB)Fax Transmission Record - GLASSIA, June 11, 2010 (PDF - 33KB)Visible Particulates in the Final Container - GLASSIA, June 8, 2010 (PDF - 45KB)Record of Telephone Conversation - GLASSIA, June 6, 2010 Information Request Email - GLASSIA, May 25, 2010 Record of Telephone Conversation - GLASSIA, May 20, 2010 Information Request and PMR/PMC Request - GLASSIA, May 20, 2010 Fax Transmission Record - GLASSIA, May 19, 2010 (PDF - 38KB)URGENT Clarification Being Requested for the Fax of May 3rd, 2010 - GLASSIA, May 11, 2010 (PDF - 46KB)Fax Transmission Record - GLASSIA, May 3, 2010 (PDF - 48KB)Fax Transmission Record - GLASSIA, April 20, 2010 RE: Some FU Questions in View of Our Discussions - GLASSIA, March 22, 2010 (PDF - 146KB)Additional Information Request Email to be added to the Fax - GLASSIA, March 19, 2010 Fax Transmisson Record - GLASSIA, March 18, 2010 Record of Telephone Conversation - GLASSIA, March 3, 2010 Fax Transmission - GLASSIA, March 3, 2010 Content of Amendment Discussed During Inspection Email - GLASSIA, February 23, 2010 Record of Telephone Conversation - GLASSIA, February 22, 2010 (PDF - 14KB)Fax Transmission Record - GLASSIA, February 2, 2010 Facsimilie Transmission Record - GLASSIA, December 9, 2009 (PDF - 109KB)Kamada A1PI Email - GLASSIA, November 27, 2009 (PDF - 17KB)Record of Telephone Conversation - GLASSIA, November 6, 2009 Conformance Lots and Friday Meeting Information - GLASSIA, November 4, 2009 Information Request Email - GLASSIA, November 3, 2009 Fax Transmission Record - GLASSIA, October 23, 2009 Fax Transmission Record - GLASSIA, September 9, 2009 Fax Transmission Record - GLASSIA, July 16, 2009 Record of Telephone Conversation - GLASSIA, June 8, 2009
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