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Vaccines, Blood & Biologics

Record of Telephone Conversation - Provenge, March 4, 2010

(System Info - 126524 OH STEVEN 04/20/2010 18:30:54 OH)


Submission Type: BLA    Submission ID: 125197/0    Office: OCTGT


Dendreon Corporation

Email Date/Time: 04-Mar-2010 05:41 PM        Initiated by FDA? Yes

Email address:

Communication Categorie(s):
1. Information Request


Telecon Summary:
Additional information request for ---(b)(4)---

FDA Participants: Steven Oh (Cc:  Valerie Coleman, Linda Weir, Keith Wonnacott, Kimberly Benton, Thomas Finn, Teresita Mercado)

Non-FDA Participants: Liz Smith

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Email Body:

Hi Liz,

Attached is a list of items that our software review team would like to request in order to complete the review of the ---(b)(4)---- software. If you have any questions regarding these requested items, we will be glad to spend a few minutes to discuss with you during tomorrow's teleconference at 1 PM eastern time. Thanks.


Steven S. Oh, Ph.D.
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, HFM-715
Rockville, MD 20852-1448
U. S. A.

Phone: 301-827-5353
Fax: 301-827-9796


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Contents of the attachment:

Additional Information Request for the ---(b)(4)--- Software

In order to complete the review of your BLA, we request the following additional information or clarification.

  1. Please provide a Software Description.
  2. Please provide a comprehensive overview of the device features that are controlled by software, and describe the intended operational environment. Generally, we recommend that you provide the information in paragraph format and highlight major or operationally significant software features. The software description should include information on the following:

    • programming language
    • hardware platform
    • operating system (include version/model)
    • use of Off-the-Shelf software (if applicable)
  3. Please provide a Software Device Hazard Analysis.
  4. The software Hazard Analysis should take into account all hazards associated with the software’s intended use, including both hardware and software hazards. We recommend that you present the information in tabular form with a line item for each identified hazard. This document can be in the form of an extract of the software-related items from a comprehensive risk management document, such as the Risk Management Summary described in ISO 14971. In this format, each line item should include:

    • identification of the hazardous event
    • severity of the hazard
    • cause(s) of the hazard
    • method of control (e.g., alarm, hardware design)
    • corrective measures taken, including an explanation of the aspects of the software     design/requirements, that eliminate, reduce, or warn of a hazardous event; and
    • verification that the method of control was implemented correctly (e.g. testing/validation)

    When performing a hazard analysis, address all foreseeable hazards, including those resulting from intentional or inadvertent misuse of the device.

    The hazards should be evaluated prior to mitigation.

  5. Please provide the Software Requirements Specification (SRS).
  6. The Software Requirements Specification (SRS) documents the requirements for the software. This typically includes functional, performance, interface, and other requirements for the software. In effect, this document describes what the Software Device is supposed to do. Software performance and functional requirements include algorithms or control characteristics for therapy, diagnosis, monitoring, alarms, analysis, and interpretation with full text references or supporting clinical data.

  7. Please provide a list of Hardware Requirements.
  8. Hardware requirements generally include:

    • microprocessors (  RAM, hard drive size)
    • memory devices
    • sensors
    • energy sources
    • safety features
  9. Please provide the Software Design Specification (SDS).
  10. The Software Design Specification (SDS) describes the implementation of the requirements for the Software Device. In terms of the relationship between the SRS and the SDS, the SRS describes what the Software Device will do and the SDS describes how the requirements in the SRS are implemented. The information presented in the SDS should be sufficient to ensure that the work performed by the software engineers who created the Software Device was clear and unambiguous, with minimal ad hoc design decisions. The SDS may contain references to other documents, such as detailed software specifications. However, the document you submit should, in and of itself, provide adequate information to allow for review of the implementation plan for the software requirements in terms of intended use, functionality, safety, and effectiveness.

  11. Please provide the Traceability Analysis.
  12. The traceability Analysis links together your product design requirements, design specifications, and testing requirements. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations. Please submit for review explicit traceability among these activities and associated documentation (e.g., test cases) because they are essential to effective product development and to our understanding of product design, development and testing, and hazard mitigations. The Traceability Analysis commonly consists of a matrix with line items for requirements, specifications and tests, and pointers to hazard mitigations. It is possible to document traceability simply through a shared organizational structure with a common numbering scheme; however, we recommend that you include some mechanism, such as a matrix for guiding the reviewer through the information you submit.

  13. Please provide the Software Development Environment Description.
  14. The submission should include a summary of the software development life cycle plan. This summary should describe your software development life cycle and the processes that are in place to manage the various life cycle activities. This document should also include an annotated list of the control/baseline documents generated during the software development process and a list or description of software coding standards.

  15. Please provide Verification and Validation (V&V) Documentation.
  16. This document should include a description of V&V activities at the unit, integration, and system level. For unit and integration level testing provide a description. System level test protocols include: pass/fail criteria (expected results), actual results, name or initials of the person who performed the test and the date the test was performed. Also please provide a test report (executive summary) which should include the number of tests performed, and the number that passed/failed.  For a test that failed please explain the reason it failed, and the results of the retest.

  17. Unresolved Anomalies (Bugs or Defects)
  18. The submission should include a list of all unresolved software anomalies. For each anomaly, please indicate the:

    • problem
    • impact on device performance
    • any plans or timeframes for correcting the problem (where appropriate)
  19. How do you ensure data security while using the -------(b)(4)---------, your secured internet site? This should also be addressed in the hazard analysis.
  20.  Please provide the actual reports (not Standard Operating Procedures, SOP) for the following as referenced on pages 11/118-17/118 of 1.6.3, Response to Request for      ---(b)(4)---- Information.
    • Computer System Validation: General Requirements and Process Overview for       Computerized Systems
    • Computer Systems Validation: Qualification of Computerized Systems
    • Exception Reporting
    • ---(b)(4)----  Performance Qualification Protocol for ---(b)(4)----  (Equip. No.  ---(b)(4)---
    • ---(b)(4)----  Performance Qualification Report for the ---(b)(4)----  System ( Equip. No. ---(b)(4)---)
    • --------(b)(4)--------------  User Manual (and Administrator’s Manual)
    • -----------------(b)(4)----------------------------------  User Manual
    • ---(b)(4)----  system Development Lifecycle Overview for ---(b)(4)---- ( Equip. No. ---(b)(4)---)
    • Backup and restore Procedure for the ----(b)(4)------  System
    • Disaster recovery Plan for the ---(b)(4)----  System
    • ---(b)(4)----  Functional Requirements Specifications for ---(b)(4)---- (Equip No. ---(b)(4)---)
    • ---(b)(4)----  Design Specification (---(b)(4)--) for ---(b)(4)---- : System Administration
    • ---(b)(4)----  Technical Design Specification (---(b)(4)---------) for --(b)(4)----------- Apheresis Lot Expiration
    • ---(b)(4)----  Technical Design Specification (---(b)(4)----- ) for -(b)(4)---  ---------(b)(4)---------- Scheduling Program
    • ---(b)(4)----  Technical Design Specification for ----------(b)(4)--------  Interface Layer
    • ---(b)(4)----  Technical Design Specification (---(b)(4)---- ) for ---(b)(4)------------------------ Workflows
    • ---(b)(4)----  Technical Design Specification: ---(b)(4)----  Clinical and Commercial Apheresis Collection Label Sets
    • ---(b)(4)--------------------  Security Roles and Permissions
    • ---(b)(4)----  Technical Design Specification: ---(b)(4)----  Apheresis Collection Site Certificate of Conformance

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