Material is organized by meeting date, with more recent meeting first.
October 9, 2009
On October 9, 2009, in open session, the Committee will discuss, ISOLAGEN THERAPY, BLA 125348, Fibrocell Technologies, Inc. (formerly Isolagen Technologies, Inc.,) for moderate to severe nasolabial fold wrinkles. Nasolabial fold wrinkles are the two skin folds that run from each side of the nose to the corners of the mouth.
- Announcement [ARCHIVED]
- Briefing Document (PDF - 933KB) [ARCHIVED]
- Draft Agenda (PDF - 20KB) [ARCHIVED]
- FDA Public Roster [ARCHIVED]
- Final Agenda [ARCHIVED]
- Minutes (PDF - 39KB) [ARCHIVED]
- Presentations [ARCHIVED]
- Roster (PDF - 36KB) [ARCHIVED]
- Sponsor Briefing Document (PDF - 2.6MB) [ARCHIVED]
- Summary Minutes [ARCHIVED]
- Transcript (PDF - 630KB) [ARCHIVED]
- Waivers for Conflict of Interest [ARCHIVED]
May 14-15, 2009
On May 14 in the morning, in open session, the Committee will discuss the potential for Chlamydia trachomatis and Neisseria gonorrhea transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system or gestational tissues (e.g., amnionic membrane and placenta, cells recovered from menstrual blood, foreskin, placental/umbilical cord blood derived cell products), or other sources.