Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Ducord
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Memoramdum/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Summary Basis for Regulatory Action - Ducord (PDF - 160KB)Clinical Review, October 2, 2012 - Ducord DCGT Deputy Director Memo, October 2, 2012 - Ducord CMC Review, October 1, 2012 - Ducord (PDF - 477KB)- Memo Instructions (PDF - 189KB)
- Labeling Review Memorandum, July 5, 2012 (PDF - 131KB)
Major Amendment Letter, June 11, 2012 - Ducord Proprietary Name Review, June 11, 2012 - Ducord Pharmacology Toxicology Review, June 22, 2012 - Ducord (PDF - 130KB)Pharmacology Toxicology Review, February 23, 2012 - Ducord (PDF - 130KB)Acknowledgment of Filing Letter, November 8, 2011 - Ducord Final Review Memo - Ducord (PDF - 267KB)
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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.
Filing Meeting Minutes, October 14, 2011 - Ducord Officer/Employee List Email, October 4, 2012 - Ducord Amendment 018 Email, September 21, 2012 - Ducord Answer to Questions Email, September 17, 2012 - Ducord Outstanding Issues Email, August 8, 2012 - Ducord Packing Label Email, August 8, 2012 - Ducord Outstanding Review Issues Email, August 6, 2012 - Ducord Outstanding Review Issues Teleconf, July 17, 2012 - Ducord (PDF - 34KB)Sterility Testing Question Tcon, July 11, 2012 - Ducord Teleconference, June 22, 2012 - Ducord Question about Consent Forms Email, June 22, 2012 - Ducord (PDF - 91KB)Teleconference - BLA update discussion, May 2, 2012 - Ducord Process Validation Proposal Email, March 30, 2012 - Ducord Response to Review Issues, December 2, 2011 - Ducord Teleconference Regarding Data - Ducord Assay Validation Protocol Telecon, Ducord Re-validating Telecon, Ducord DE and Collection Questions, February 22, 2012 - Ducord Post Mid-Cycle Telecon, February 22, 2012 - Ducord Assay Procedures Email, February 13, 2012 - Ducord Discussion Points Email, February 09, 2012 - Ducord Viability Assay Validation Protocol Telecon, January 23, 2012 - Ducord Discussion of Responses Telecon, January 6, 2012 - Ducord Record of Telephone Conversation, September 29, 2011 - Ducord FDA Required List Email, September 29, 2011 First Meeting Minutes, September 28, 2011 - Ducord
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