Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - GINTUIT
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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.
CMC Review, March 8, 2012 - Gintuit (PDF - 877KB)Clinical Review, March 8, 2012 - Gintuit (PDF - 401KB)Final Review Memorandum, February 29, 2012 - Gintuit (PDF - 77KB)Bioresearch Monitoring Inspection Results, December 8, 2011 - Gintuit (PDF - 31KB)Organogenesis Review Memo, March 12, 2012 - Gintuit (PDF - 136KB)Pharmacology/Toxicology Review - Gintuit (PDF - 1.1MB)Statistical Review and Evaluation, May 13, 2011 - Gintuit (PDF - 243KB)
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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.
Update Regarding Master File for rh-insulin Email, February 29, 2012 - Gintuit (PDF - 57KB)Organogenesis Information Request Email, February 27, 2012 - Gintuit (PDF - 50KB)Deferred Pediatric Study Telecon, February, 23, 2012 Summary of Telecon, February 13, 2012 - Gintuit Information Request, February 8, 2012 - Gintuit Pediatric Study Email, January 27, 2012 - Gintuit (PDF - 56KB)Discuss Responses to 483 Observations Telecon, January 26, 2012 - Gintuit CMC related information request, December 7, 2011 - Gintuit CMC Related Information Request, November 8, 2011 - Gintuit CMC Information Request, September 12, 2011 - Gintuit CMC Related Information Request, August 26, 2011 - Gintuit Information Related to the Cell Banking System, August 19, 2011 - Gintuit Information Request, Product Quality, August 12, 2011 - Gintuit Summary of PVP Email, July 21, 2011 - Gintuit Information Request Email, July 7, 2011 - GINTUIT (PDF - 18KB)Telecon, July 1, 2011 - Gintuit Information Request, June 23, 2011 - Gintuit (PDF - 18KB)Preclinical Comments - Gintuit
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