Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Corifact
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Memorandums/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Re-evaluation Memo, February 14, 2011 - Corifact Memo - Teleconference CSLB, February 9, 2011 - Corifact (PDF - 19KB)Memo - Teleconference with CSLB Marburg, Germany, January 18, 2011 - Corifact Memo - Inspection Waiver, January 5, 2011 - Corifact Memo - Final Summary Review, December 29, 2010 - Corifact Mid-cycle/Final Review Memorandum , November 22, 2010 - Corifact (PDF - 144KB)Mid-cycle Meeting Summary, November 16, 2010 - Corifact Memo - Proprietary Name Review, November 9, 2010 - Corifact Memo - Filing of Factor XIII Concentrate (Human) BLA, October 12, 2010 - Corifact - Memo - First Committee Meeting Summary,September 8, 2010 - Corifact
Memo - Categorical Exclusion - Corifact BLA Filing Letter - Corifact Proprietary Name Acceptance Lettter - Corifact Midcycle Pharmacology / Toxicology Review - Corifact - Pharmacology/Toxicology Review - Final - Corifact
Memo - Nonclinical Labeling - Corifact Memo - Blood Products Advisory Committee, November 26, 2010 - Corifact - Clinical Pharmacology Review 2, August 18, 2010 - Corifact (PDF - 122KB)
- Statistical Review and Evaluation - Final, August 18, 2010 - Corifact (PDF - 199KB)
Memo - DMPQ Review Addendum - Corifact (PDF - 20KB)- Memo - Addendum to CMC review - Corifact
Memo - Mid-cycle Review of CMC (PDF - 265KB)Memo - DMPQ Review Memo - Corifact (PDF - 196KB)Memo - Final Review of CMC - Corifact (PDF - 315KB)Final Clinical Review - Corifact (PDF - 380KB)Statistical Review and Evaluation BLA - Mid-Cycle Review - Corifact (PDF - 162KB)
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Administrative Documents
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
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Correspondence
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Record of Telephone Conversation, February 11, 2011 - Corifact Record of Telephone Conversation, February 10. 2011 - Corifact (PDF - 10KB)Telecon - Information Request, January 11, 2011 - Corifact Email- FXIII Questions from January 11, 2011 telecon, January 12, 2011 Email, January 11, 2011 - Corifact FACSIMILE TRANSMISSION RECORD, December 2, 2010 - Corifact FACSIMILE TRANSMISSION RECORD, October 21. 2010 - Corifact FACSIMILE TRANSMISSION RECORD, September 9, 2010 - Corifact Fast Track Development Program, August 27, 2010 - Corifact Teleconference, August 20, 2010 - Corifact
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