Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - Berinert
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Memorandum/Reviews
Statistical Review and Evaluation - Berinert (PDF - 114KB)Recommend Approval - Memo, October 10, 2009 - Berinert CMC Final Review Memo and Recommendation - Berinert, October 9, 2009 Categorical Exclusion Memo - Berinert, October 5, 2009 Review of Proposed Proprietary Name - Berinert, September 30, 2009 Final Review Memo for Viral - Berinert, September 22, 2009 Review Memo for Pharmacovigilance Planning - Berinert, September 21, 2009 Pharmacology / Toxicology Review Memorandum - Berinert, September 10, 2009 (PDF - 117KB)Statistical Review and Evaluation (PDF - 189KB)Second Cycle Re-Evaluation Memo- Berinert, August 20, 2009 BPAC Waiver Memo - Berinert, August 3, 2009 Validation of Manufacturing Process - Berinert, August 4, 2009 Summary of Bioresearch Monitoring Inspections - Berinert, Clinical Pharmacology Review (PDF - 85KB)Clinical Pharmacology Review - Berinert (PDF - 92KB)Final CMC Stability Review Memo - Berinert, December 5, 2008 Medical Officer Clinical Final Review of Original BLA - Berinert, (PDF - 1.4MB)Review memo for analytical method validation - Berinert, November 6, 2008 (PDF - 65KB)Review for Pharmacovigilance Planning - Berinert, October 22, 2008 Major Amendment Justification Memo - Berinert - June 26, 2008 Pharmacology / Toxicology Review Memorandum - Berinert, June 2, 2008 (PDF - 116KB)Clinical Review of Priority Review - Berinert, March 6, 2008 Medical Review of Sponsor's Complete Response to CR Letter - Berinert (PDF - 1.5MB)
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Correspondence
Mid-Cycle Post Resubmission Meeting Summary - Berinert, July 1, 2009 First Committee Post Resubmission Meeting Summary - Berinert, May 26, 2009 Complete Response Letter - Berinert, December 5, 2008 (PDF - 123KB)Amendment Letter - Berinert, July 8, 2008 Resubmission Acknowledgement Letter - Berinert, June 30, 2009 Mid-cycle Meeting Summary - Berinert, June 4, 2008 Filing Letter - Berinert, May 5, 2008 Filing Meeting Summary - Berinert, April 18, 2008 Medical Review of Sponsor's Complete Response to CR Letter - Berinert, April 10, 2009 (PDF - 217KB)First Committee Meeting Summary - Berinert, March 25, 2008 Acknowledgment Letter - Berinert, March 17, 2008 Recommend Complete Response Letter - Berinert (PDF - 101KB)
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