Vaccines, Blood & Biologics
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Approval History, Letters, Review, and Related Documents - Bivigam
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Memoranda/Reviews
Chairs Final Review Memo, July 31, 2012 - Bivigam (PDF - 72KB)Complete Response Memo, July 14, 2012 - Bivigam (PDF - 77KB)Categorical Exclusion Memo RAC Letter Addendum to Pharmacovigilance Review Memo April 23, 2012 - Bivigam Final CMC Review, April 12, 2012 - Bivigam (PDF - 366KB)Process Validation Memo, April 2, 2012 - Bivigam (PDF - 366KB)Proprietary Name Review Approval Letter - Bivigam Nonclinical Pharmacology/Toxicology Memo - Bivigam (PDF - 42KB)- Proposed Proprietary Name Evaluation Memo, February 16, 2012 - Bivigam
Filing Memo, November 22, 2011 - Bivigam (PDF - 192KB)Final Chair Memo, August 26, 2011 - Bivigam (PDF - 82KB)Nonclinical Pharmacology/Toxicology Final Memo, August 14, 2011 - Bivigam (PDF - 124KB)Final Process Validation Memo, August 12, 2011 - Bivigam (PDF - 106KB)- Proposed Proprietary Name Evaluation Memo, August 11, 2011 - Bivigam
BIMO Final Summary Memo, July 19, 2011 - Bivigam Pharmacovigilance Review Memorandum, June 21, 2011 - Bivigam (PDF - 963KB)Clinical Pharmacology BLA Review Memo, April 1, 2011 - Bivigam (PDF - 415KB)MidCycle Review Memo, March 31, 2011 - Bivigam (PDF - 122KB)Bioresearch Monitoring Mid-Cycle Review Memo, March 15, 2011 - Bivigam Mid-cycle Memo, March 11, 2011 - Bivigam (PDF - 100KB)Acknowledgement Letter - Bivigam Third Complete Response Review Memo - Bivigam (PDF - 64KB)Waiver Memo - Bivigam Complete Response Letter, Mr. Vaughn - Bivigam Statistical Review and Evaluation, Bivigam (PDF - 76KB)Clinical Pharmacology Final Review Memo - Bivigam (PDF - 388KB)Review Memo - Bivigam (PDF - 84KB)Final Statistical Review Memo - Bivigam (PDF - 2.5MB)Final Clinical Review - Bivigam (PDF - 686KB)Final Clinical Review Memorandum - Bivigam (PDF - 87KB)Mid-cycle Clinical Review Memo - Bivigam (PDF - 571KB)CMC Mid-cycle Review Memo - Bivigam (PDF - 90KB)Memorandum of Filing, December 16, 2010 - Bivigam (PDF - 47KB)Complete Response Memo - Bivigam (PDF - 91KB)Final Viral Clearance Memo - Bivigam (PDF - 189KB)Final Clinical Review Memo - Bivigam (PDF - 745KB)Complete Response Letter - Bivigam (PDF - 78KB)Final Viral Clearance - Bivigam (PDF - 182KB)MidCycle Viral Clearance - Bivigam (PDF - 177KB)CMC Final Review Memo - Bivigam (PDF - 116KB)
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Correspondence
First Committee Meeting Minutes, December 22, 2012 - Bivigam CMC related PMCs for Bivigam Email, December 03, 2012 - Bivigam Information Request Email, November 29, 2012 - Bivigam (PDF - 33KB)Information Email, November 08, 2012 - Bivigam (PDF - 8KB)Offical Meeting Summary Memo, September 10, 2012 - Bivigam (PDF - 90KB)Meeting Response Memorandum, September 5, 2012 - Bivigam (PDF - 78KB)Biotest Questions Email, September 05, 2012 - Bivigam (PDF - 14KB)Information Request Email, July 18, 2012 - Bivigam (PDF - 45KB)Complete Response Letter, July 12, 2012 - Bivigam Information Request, June 21, 2012 - Bivigam (PDF - 33KB)Information Request Email, June 11, 2012 - Bivigam (PDF - 33KB)- Information Request Email, April 24, 2012 - Bivigam (PDF - 28KB)
Chairs Final Review Memo, April 20, 2012 - Bivigam (PDF - 59KB)Information Request Email, April 20, 2012 - Bivigam (PDF - 46KB)Information Request Email, April 13, 2012 - Bivigam (PDF - 34KB)Information Request, April 05, 2012 - Bivigam Information Request Email, April 04, 2012 - Bivigam Information Request Email, April 02, 2012 - Bivigam (PDF - 45KB)Information Request, March 02, 2012 - Bivigam (PDF - 75KB)Information Request Email, February 21, 2012 - Bivigam (PDF - 32KB)Information Request Email, February 13, 2012 - Bivigam Information Request, January 19, 2012 - Bivigam (PDF - 45KB)Meeting Cover Letter - Bivigam Resubmission Acknowledgement Letter - Bivigam Filing Letter - Bivigam Second Information Request, November 03, 2011 - Bivigam (PDF - 53KB)Information Request Email, July 22, 2011 - Bivigam (PDF - 53KB)Information Request Email, April 8 2011 - Bivigam (PDF - 71KB)Information Request II Email, April 8 2011 - Bivigam (PDF - 47KB)Information Request Email , April 7, 2011 - Bivigam Information Request I, April 7 2011 - Bivigam (PDF - 88KB)Information Request Email, April 7, 2011 - Bivigam Information Request III, April 7 2011 - Bivigam (PDF - 65KB)Information Request Email, March 02, 2011 - Bivigam (PDF - 37KB)Request for Feedback, February 17, 2011 - Bivigam (PDF - 83KB)Information Request, February 10, 2011 - Bivigam (PDF - 33KB)Information Request Email, February 02, 2011 - Bivigam (PDF - 32KB)Filing Memo Email, December 29, 2010 - Bivigam (PDF - 33KB)Filing Meeting Minutes, December 22, 2010 - Bivigam Information Request Email, December 21, 2010 - Bivigam (PDF - 33KB)- Filing Meeting Email, December 17, 2010 (PDF - 40KB)
Filing Meeting Email II, December 17, 2010 (PDF - 43KB)Filing Memo Email, December 16, 2010 - Bivigam (PDF - 15KB)Filing Memo Email II, December 16, 2010 - Bivigam (PDF - 42KB)Filing Memo Email III, December 16, 2010 - Bivigam (PDF - 42KB)Filing Memo Email IV, December 16, 2010 - Bivigam (PDF - 43KB)Filing Memo Email V, December 16, 2010 - Bivigam (PDF - 41KB)Filing Memo Email VI, December 16, 2010 - Bivigam (PDF - 41KB)Filing Memo Email VII, December 16, 2010 - Bivigam (PDF - 44KB)Filing Memo Email VIII, December 16, 2010 - Bivigam (PDF - 44KB)Information Request Email, December 10, 2010 - Bivigam (PDF - 13KB)Bioresearch Monitor Filing Memo, December 7, 2010 - Bivigam Establishment Evaluation Request, Bivigam First Committee Meeting Email, November 29, 2010 - Bivigam (PDF - 35KB)
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