Submission Type: BLA Submission ID: 125348/0 Office: OCTGT
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Vaccines, Blood & Biologics
Autologous Cultured Fibroblasts
Fibrocell Technologies, Inc.
Telecon Date/Time: 08-Sep-2009 02:00 PM Initiated by FDA? Yes
1. Information Request
Author: LORI TULL
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
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.