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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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:

  1. We consider the PA2024 protein to be an active ingredient. Please modify reference to this material to reflect this in future submissions.
  2. 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.
  3. 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.
  4. 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.
  5. 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)