Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - HPC, Cord Blood
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Memorandum/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Barcode Exemption Letter, May 24, 2012 - HPC Cord Blood Clinical and Statistical Review, May 23, 2012, HPC Cord Blood (PDF - 439KB)Review Memo, May 23, 2012 - HPC Cord Blood Major Amendment Acknowledgement, February 2012 - HPC Cord Blood AI Letter, October 28, 2011 - HPC Cord Blood Filing Review Letter, July 15, 2011 - HPC Cord Blood - Acknowledgment of Filing, July 1, 2011 - HPC Cord Blood
CMC Review - HPC Cord Blood (PDF - 424KB)- Pharmacology Toxicology Filing Checklist - HPC Cord Blood (PDF - 72KB)
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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.
Email - Information Request, May 31, 2011 - HPC Cord Blood Planning Meeting Minutes, May 24, 2011 - HPC Cord Blood Fax - RE: BLA125391 - PI, May 21, 2012 - HPC Cord Blood Telecon, May 10, 2012 - HPC Cord Blood Telecon, May 7, 2012 - HPC Cord Blood Email - Labeling, May 2,2012 - HPC Cord Blood - Telcon, March 9, 2012 - HPC Cord Blood
Telecon, March 1, 2012 - HPC Cord Blood Telecon, February 2, 2012 - HPC Cord Blood Telecon, January 27, 2012 - HPC Cord Blood Telecon, January 20, 2012 - HPC Cord Blood Telecon, January 19, 2012 - HPC Cord Blood Telecon, January 17, 2012 - HPC Cord Blood Telecon, January 13, 2012 - HPC Cord Blood Telecon, January 10, 2012 - HPC Cord Blood Telecon, January 5, 2012 - HPC Cord Blood Wrap up Meeting Minutes - HPC Cord Blood (PDF - 18KB)Telecon, December 22, 2011- HPC Cord Blood Telecon, December 6, 2011- HPC Cord Blood Telecon, December 2, 2011 - HPC Cord Blood Telecon, December 1, 2011 - HPC Cord Blood Telecon, November 11, 2011- HPC Cord Blood Telecon, November 11, 2011, noon - HPC Cord Blood Midcycle Meeting Agenda - HPC Cord Blood (PDF - 36KB)Telecon, October 3, 2011 - HPC Cord Blood Telecon - IRL, October 3, 2011 - HPC Cord Blood Telecon, September 21, 2011 - HPC Cord Blood Telecon, August 10, 2011 - HPC Cord Blood Telecon, August 3, 2011 - HPC Cord Blood Telecon, June 27 2011 - HPC Cord Blood Filing Meeting Minutes, June 21, 2011 - HPC Cord Blood Telecon, June 14, 2011 - HPC Cord Blood Telecon, May 31, 2011 - HPC Cord Blood
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