Vaccines, Blood & Biologics
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Approval History, Letter, Reviews, and Related Documents - VARIZIG
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Memorandum/Reviews
- Review Memorandum - VARIZIG, January 15, 2013 (PDF - 58KB)
Clinical Review Memo - VARIZIG, December 29, 2012 (PDF - 20MB)Summary Basis for Regulatory Action - VARIZIG, December 20, 2012 (PDF - 341KB)Review Memorandum - VARIZIG, December 15, 2012 (PDF - 29KB)Internal Review Memorandum - VARZIG, December 11, 2012 Process Validation Final Review - VARIZIG, November 26, 2012 (PDF - 241KB)Filing Letter - VARIZIG, November 8, 2012 Mid-Cycle Meeting Summary - VARIZIG, October 1, 2012 Bioresearch Monitoring Midcycle Review - VARIZIG, September 27, 2012 (PDF - 44KB)Process Validation Midcycle Review - VARIZIG, Sepember 27, 2012 (PDF - 222KB)Filing Meeting Summary - VARIZIG, August 13, 2012 First Committee Meeting Summary - VARIZIG, July 23, 2012 - Clinical Pharmacology Review - VARIZIG, June 29, 2012 (PDF - 540KB)
Statistical Review and Evaluation - VARIZIG, June 28, 2012 (PDF - 354KB)Statistical Review and Evaluation - VARIZIG, June 28, 2012 (PDF - 417KB)Internal Review- VARIZIG (PDF - 47KB)- BLA Review Memo - VARIZIG (PDF - 254KB)
- Preclinical Pharm-Tox Review -VARIZIG (PDF - 46KB)
Original BLA: Final Review, Drug Substance and Drug Product stability & potency assay validation - VARIZIG (PDF - 61KB)Viral Clearance Final Review Memo -VARIZIG (PDF - 186KB)Pharmacovigilance Plan Review Memo - VARIZIG (PDF - 774KB)Final CMC Review - VARIZIG (PDF - 182KB)Preclinical Pharm-Tox Midcycle Review - VARIZIG (PDF - 46KB)Viral Clearance Validation Mid-Cycle Review Memo - VARIZIG (PDF - 163KB)VirataTheimer Midcycle CMC Review Memo - VARIZIG (PDF - 154KB)Proprietary Name Review Acceptance Letter -VARIZIG BLA Filing Letter - VARIZIG
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Correspondence
Record of Telephone Conversation - VARIZIG, December 5, 2012 Record of Telephone Conversation - VARIZIG, December 3, 2012 Labeling Comments - VARIZIG, November 29, 2012 Information Request - VARIZIG, November 15, 2012 Information Request -VARIZIG - November 2, 2012 Information Request -VARIZIG, October 9, 2012 Information Request - VARIZIG, October 4, 2012 (PDF - 141KB)Information Request - VARIZIG, October 4, 2012 (PDF - 94KB)Information Request - VARIZIG, October 2, 2012 Hemolysis Reports - VARIZIG, September 26, 2012 Information Request - VARIZIG, August 12, 2012 Teleconference Meeting Minutes - VARZIG
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