Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Laviv
STN: BL 125348/0
Proper Name: Laviv
Trade Name: Azficel-T
Manufacture: Fibrocell Technologies, Inc.
Indication: Indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.
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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.
Review Memo of Fibrocell Training Manual, Laviv (PDF - 111KB)Clinical Review of BLA Resubmissions, June 20, 2011 - Laviv (PDF - 146KB)DDDP Consult # 1343 Memo, May 10, 2011 - Laviv (PDF - 39KB)DDDP Consult # 1343 Memo, April 8, 2011 - Laviv (PDF - 419KB)- Pharmacovigilance Review Memorandum, April 5, 2011 - Laviv (PDF - 53KB)
Complete Response Letter, December 18, 2009 - Laviv (PDF - 38KB)Clinical Review, December 9, 2009 - Laviv (PDF - 699KB)Review Memo, December 9, 2009 - Laviv Final Review for Pharmacovigilance Planning, December 8, 2009 - Laviv (PDF - 217KB)Review Memo, November 25, 2009 - Laviv (PDF - 196KB)Statistical Review and Evaluation, November 19, 2009 - Laviv (PDF - 283KB)Bioresearch Monitoring Inspection Results, November 10, 2009 - Laviv (PDF - 15KB)Pediatric Research and Equity Act Waivers - Laviv Mid-Cycle Memo - Isolagen Treatment, August 18, 2009 - Laviv (PDF - 210KB)Isolagen Therapy Memo, August 11, 2009 - Laviv (PDF - 59KB)Bioresearch Monitoring Mid-Cycle Review, August 11, 2009 - Laviv Filing Review Letter, May 19, 2009 - Laviv (PDF - 25KB)Filing Review, May 5, 2009 - Laviv Filing Action Memo, April 20, 2009 Filing Action Memo - Laviv Final CMC Review - Laviv (PDF - 559KB)CMC Final Review - Laviv (PDF - 496KB)Pharm -Tox Review - Laviv (PDF - 969KB)
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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.
IT-H-001 Status and Request for Short Phone Call Email, June 28, 2010 - Laviv Amendment 046 - Final Prescribing Information, June 20, 2011 - Laviv Final Prescribing Information Email, June 20, 2011 - Laviv Draft registry outline for PMR Email, June 15 2011 - Laviv Record of Telephone Conversation, May 26, 2011 - Laviv Question for Fibrocell Email, May 12, 2011 - Laviv Question for Fibrocell Email, May 11, 201 - Laviv Telecon, April 7, 2011 - Laviv (PDF - 24KB)Teleconference, April 7, 2011 - Laviv Safety Data Issues for Discussion Email, April 4, 2011 - Laviv (PDF - 16KB)Fibrocell Label Email, March 24, 2011 - Laviv Request for information Email, March 17, 2011 - Laviv Request for Clarification Email, March 15, 2011 - Laviv Request for Clarification Email, March 14, 2011 - Laviv (PDF - 31KB)Request for Histological Records Email, March 02, 2011 - Laviv Request for information, February 24, 2011 - Laviv Fibrocell BLA 125348 Review Team Meeting, Feburary 23, 2011 - Laviv OCTGT Consultation Questions Email, February 23, 2011 - Laviv Request for Information Email, February 18, 2011 - Laviv Fibrocell Telecon Summary, February 16, 2011 - Laviv (PDF - 15KB)Review Team Meeting, January 13, 2011 - Laviv (PDF - 26KB)Fibrocell Resubmission Email, January 5, 2011 Unblinding Update Email, December 7, 2010 - Laviv Teleconference with Dr. Lynn Drake, April 1, 2010 - Laviv Fibrocell Histopathology Study Discussion Email, January 28, 2010 - Laviv Telecon #2, November 9, 2009 - Laviv Telcon held with Fibrocell Science Inc October 30, 2009 - Laviv Review Team Meeting Minutes, October 23, 2009 - Laviv (PDF - 36KB)Telecon #1, October 20, 2009 - Laviv Clarification regarding AE tables Email, October 05, 2009 - Laviv Confirmed DMEM Email, October 07, 2009, Laviv Review Team Meeting Minutes, September 17, 2009 - Laviv (PDF - 23KB)Record of Telephone Conversation, September 8, 2009 - Laviv Proposed Alternatives for Isolagen Email, September 1, 2009 - Laviv Midcycle Meeting Minutes, August 13, 2009 - Laviv (PDF - 31KB)Record of Telephone Conversation August 26, 2009 - Laviv Review Team Meeting Minutes, August 20, 2009 - Laviv FDA Advisory Committee Meeting Email (ctgtac roster), June 25, 2009 - Laviv Follow-up re Reformatting of Integrated Datasets Email, July 9, 2009 - Laviv Record of Telephone Conversation, July 8, 2009 - Laviv Review Team Meeting with Dr. Witten, July 7, 2009 - Laviv (PDF - 29KB)Meeting to Discuss Pharmacovigalnce Planning, June 24, 2009 - Laviv Review Team Meeting, June 18, 2009 - Laviv Telecon with Isolagen, June 1, 2009 - Laviv Review Team Meeting Minutes, May 21 2009 - Laviv Dr. Witten Briefing Meeting, April 30, 2009 - Laviv (PDF - 42KB)Filing Meeting Minutes, April 17, 2009 - Laviv Review Team Meeting Agenda Minutes, March 19 2009 - Laviv
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