Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - Gammaplex
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Memoranda/Reviews
DMPQ Memo - September 3, 2009 (PDF - 178KB)Final Review CMC Memo - September 2, 2009 (PDF - 95KB)Final CMC review memo- August 30, 2009 (PDF - 104KB)CMC REVIEW - VIRAL SAFETY - August 28, 2009 (PDF - 62KB)Clinical Review Memorandum - August 28, 2009 (PDF - 586KB)Statistical Review and Evaluation, August 27, 2009 - Gammaplex Review for Pharmacovigilance Planning - August 27, 2009 - Gammaplex Bioresearch Monitoring Inspection Results - August 20, 2009 Pediatric Plan - July 30, 2009 Nonclinical Pharmacology/Toxicology Memo - June 25, 2009 PEDIATRIC PAGE - Gammaplex (PDF - 115KB)Review Memorandum - May 4, 2009 Midcycle Review Meeting - April 16, 2009 Acknowledgement Letter - December 5, 2008 Clinical Pharmacology Review - Gammaplex (PDF - 223KB)Summary Basis for Regulatory Action - Gammaplex, August 24, 2009 (PDF - 246KB)
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Correspondence
PeRC Decision - October 2, 2009 Telecon - August 28, 2009 Telecon Advice - August 25, 2009 Telecon PNR - August 12, 2009 Info Request PNR Issue - July 21, 2009 Labeling Meeting Summary - May 5 2009 and May 8, 2009 Filing Letter - January 16, 2009 Filing Meeting Summary - January 6, 2009 First Meeting - December 11, 2008
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