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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, September 8, 2009 - Laviv

Submission Type: BLA    Submission ID: 125348/0    Office: OCTGT

Product:
Autologous Cultured Fibroblasts
 
Applicant:
Fibrocell Technologies, Inc.
 
Telecon Date/Time: 08-Sep-2009 02:00 PM        Initiated by FDA? Yes
 
Telephone Number:
 
Communication Categorie(s):
 
1. Information Request
 
Author: LORI TULL
Telecon Summary:
Clinical information requested
FDA Participants: Yao-Yao Zhu, Lori Tull
Non-FDA Participants: Jessica Allmond
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
 
Telecon Body:
 
FDA stated that there were some patients that still had ongoing cases and requested CRFs for patients -----(b)(6)--------------------, and for any other patients with ongoing cases. FDA asked Isolagen to provide their version of the ongoing cases from the integrated safety and provide subject numbers and CRFs for studies 001, 002 and 007. 
FDA noted that there were inconsistencies with ITR002. The AE table of side effects was inconsistent with the database and asked Isolagen to explain this inconsistency.