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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation August 26, 2009 - Laviv

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

  Product:
  Autologous Cultured Fibroblasts

Applicant:
  Fibrocell Technologies, Inc.

  Telecon Date/Time: 26-Aug-2009  02:00 PM        Initiated by FDA? Yes

  Telephone Number:

  Communication Categorie(s):
  1. Advice
 
  Author: LORI TULL

  Telecon Summary:
  Discussion regarding indication  statement

  FDA Participants: Changting  Haudenschild, Agnes Lim, Bruce Schneider, Lori Tull

  Non-FDA Participants: Jeanne  Novak, Jessica Allmond, David Hines

  Trans-BLA Group: No
 
  Related STNs: None

  Related PMCs: None

  Telecon Body:
  FDA suggested a change in the  indication from treatment to “indicated for the temporary improvement of  moderate to severe nasolabial fold wrinkles”.   Isolagen responded that there was the potential for long term  improvement and “temporary” would be contrary to their data.  FDA stated that only 6 months of efficacy  data was available.  Isolagen replied  that they understood, but the intention of the treatment was long-term.  Isolagen requested that “for at least 6  months” or “up to 6 months” be used.  FDA  responded that they would discuss the issue internally and get back to  Isolagen.