
 
  


Information Request, February 8, 2012 - Gintuit



 
 

Additional information to be included to the response to FDA Information Request 
from January 26, 2012 Telecon

 

 

Bovine Pituitary Extract (BPE)

 

We note that –b(4)--- sources for bovine pituitary extract (BPE) are included in 
the Quality Material Specifications (QMS):

 

[                                         b(4)                                   
                  ]

 
  In BLA section 3.2.S.2.3.1.2 (Manufacture of Bovine Pituitary Extract), it 
  states that pituitary glands from cattle sourced from –b(4)------- “will be 
  used in the         --b(4)-----------------------------------------”. Please 
  clarify what source is currently utilized for BPE manufacture, and if not 
  already using material sourced from the   --b(4)-------- cattle, define when 
  this change will occur.

 
  ----b(4)--- 
  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

---b(4)-----------------

 
  Regarding the –b(4)-------------- that is used for Apligraf manufacture, we 
  have not been able to locate information regarding the methods used for 
  monitoring the –b(4)-- used for collection of this reagent and the procedures 
  that are followed to prevent its contamination with prohibited materials 
  during collection. Please provide this information.

 

Primary Packaging

 
  In BLA Section 3.2.P.2.6.1, it states that compatibility studies were 
  performed for the tray and lid assembly and culture insert ring. Please 
  provide complete study reports of the following studies that were described 
  briefly in the BLA:

 
    –b(4)- Systemic Toxicity Study in Mice
    –b(4)- Intracutaneous Toxicity Study in Rabbits
    –b(4)- Muscle Implantation Study in Rabbits
    Cytotoxicity (NCLVP/R-0332-001)
    Extractables (NCLVP/R-0332-001)
    Material Identity (NCLVP/R-0332-001)
 

   
 