
 

Teleconference Memorandum: Product Questions - Provenge, April 23, 2007



 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 


TELECONFERENCE MEMORANDUM                                                        
                   Public Health Service
                                                                                 
                                      Food and Drug Administration
                                                                                 
                                      Center for Biologics Evaluation and 
Research

 

Date\Time: April 23, 2007

CBER Representatives: Keith Wonnacott, Malcolm Moos, Lori Tull

Sponsor’s Representative: Elizabeth Smith

STN : 125197/0

Subject: Product Questions

Discussion:

The following requests were conveyed to Dendreon:
  We consider the PA2024 protein to be an active ingredient. Please modify 
  reference to this material to reflect this in future submissions.
  The changes to the b(4) lifetime and process intermediate hold time validation 
  studies proposed in your email of March 26, 2007 were acceptable. Please 
  document them in a future submission.
  With one exception, the revised process control limits proposed in the same 
  communication were acceptable. We request that the upper limit for protein 
  concentration measured by b(4) be set in such a way as to flag a b(4) error or 
  equipment failure. Accordingly, the upper limit should be set to a value 
  consistent with an within the b(4) limit you proposed, whichever is less. We 
  note also that upper and lower limits b(4) for the described in 
  A4-3.2.S.2.3.4.2.1 ( b(4) Part 1 p. 997) should also be specified. Please 
  document the revised limits in a future submission.
  In A4-3.2.S.2.3.4.2.1 (p. 997, paragraph 4), an b(4) is carried out for 
  “b(4)”. Please establish upper and lower limits and include them in a future 
  submission.
  In a future submission, please provide an SOP for the qualitative b(4) for 
  PA2024 described in A4-3.2.P.3.4.2.1.1, including a comparison standard for 
  b(4).

OCTGT:IOD:Tull:4/23/07
(N:/IOD/Tull/125197/tcons/042307_clin.doc)
 

   