RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125197/0 Office: OCTGT
Telecon Date/Time: 05-Mar-2010 02:00 PM Initiated by FDA? Yes
1. Information Request
Author: LORI TULL
Request for information regarding software and CMC
FDA Participants: Lori Tull, Linda Weir, Valerie Coleman, Steven Oh, Tom Finn, Malcolm Moos, Keith Wonnacott
Non-FDA Participants: Liz Smith, Connie Spooner, Karen Krstulich, Heidi Hagen, Mike Poor, Bob Melkerson, Mary Coon, Georgeta Puscalau, Cyril Possa, Christine Benedict
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Dendreon noted that they made all documents regarding the ---(b)(4)--- software available on inspection. Dendreon stated that they wanted to provide the information, but were concerned that it would be 800 to 1000 pages of documents. CBER responded that this number of pages was not surprising.
CBER asked if the ---(b)(4)--- software made any calculations. Dendreon responded no, the (b)(4) does the calculation for ----b(4)---------------------------------. The ---(b)(4)--- software is a planning tool for scheduling, but does not control the manufacturing process.
CBER asked if Dendreon had done a hazard analysis on the software. Dendreon responded that they did not do a hazard analysis, but did do a risk assessment worst case if the timing was off. Dendreon reiterated that ---(b)(4)--- does not control anything, but only creates a schedule.
CBER asked Dendreon to submit what was provided on inspection. Dendreon agreed to do so.
CBER asked Dendreon to provide information on how they would train staff to ensure product quality and to provide a description of step times and QC sample hold times.