Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Kedbumin
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Memorandum/Reviews
Summary Basis for Regulatory Action, June 1, 2011 - Kedbumin Pharmacovigilance Review Memorandum, May 18, 2011 - Kedbumin (PDF - 32KB)CMC Method Validation, May 6, 2011 - Kedbumin (PDF - 158KB)Statistical Review and Evaluation, April 28, 2011 - Kedbumin (PDF - 85KB)Memorandum Categorical Exclusion - Kedbumin (PDF - 26KB)Re-evaluation of proposed proprietary name KEDBUMIN Memorandum, March 28, 2011 - Kedbumin (PDF - 16KB)Recommendation to Waive Pre-Approval Inspection Memo, February 17, 2011 - Kedbumin (PDF - 23KB)Pharmacology / Toxicology Review Memorandum, January 10, 2011 - Kedbumin (PDF - 34KB)Labeling Review Memo, January 3, 2011- Kedbumin (PDF - 52KB)First Cycle Review Memo - Kedbumin (PDF - 168KB)Clinical Review Memo - Kedbumin (PDF - 314KB)Response Review Memo - Kedbumin (PDF - 69KB)CMC Method Validation - Kedbumin (PDF - 47KB)Proprietary Name Review, October 13, 2010 - Kedbumin (PDF - 78KB)
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Correspondence
Email Request for Compliance Check, June 3, 2011 - Kedbumin (PDF - 74KB)OBRR Lot Release Clearance Memo Email, June 3, 2011 - Kedbumin Information Request, Lot Release Protocol Updates Email, June 3, 2011 - Kedbumin (PDF - 17KB)Request for Compliance Check Email, June 3, 2011 - Kedbumin Information Request Email, May 27, 2011 - Kedbumin Questions on Vial Hanger Email, May 20, 2011 - Kedbumin Information Request Letter, May 19 2011 - Kedbumin Information Request Letter, May 16, 2011 - Kedbumin (PDF - 25KB)Information Request Letter, May 10, 2011 - Kedbumin (PDF - 19KB)Information Request, April 28, 2011 - Kedbumin (PDF - 26KB)Labeling Review Email, April 28, 2011 - Kedbumin (PDF - 15KB)Information Request Letter, April 11, 2011 - Kedbumin (PDF - 21KB)Information Request Letter2, April 11, 2011 - Kedbumin Kedbumin BLA Question Email, March 14, 2011 - Kedbumin Record of Telephone Conversation, March 2, 2011 - Kedbumin Record of Telephone Conversation, February 16, 2011 - Kedbumin Information Request, January 21, 2011 - Kedbumin Information Request, January 20, 2011 - Kedbumin Kedrion Albumin BLA lot release and sample submission Email, January 19, 2011 - Kedbumin (PDF - 15KB)Labeling Information Request, January 20, 2011 - Kedbumin (PDF - 41KB)Kedrion BLA Email, October 20, 2010 - Kedbumin Kedrion Original BLA, September 10, 2010 - Kedbumin Information Request, September 3, 2010 - Kedbumin
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