
 

Record of Telephone Conversation - Provenge, March 4, 2010


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

RECORD OF TELEPHONE CONVERSATION (Email)

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

Product:
 Sipuleucel-T

Applicant:
 Dendreon Corporation

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

Email address: lsmith@Dendreon.com

Communication Categorie(s):
 1. Information Request

 Author: STEVEN OH

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

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
steven.oh@fda.hhs.gov

 

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED 
AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM 
DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to 
deliver the document to the addressee, you are hereby notified that any review, 
disclosure, dissemination, copying, or other action based on the content of this 
communication is not authorized. If you have received this document in error, 
please notify the sender immediately by e-mail or phone.

 

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.
  Please provide a Software Description.

  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)

  Please provide a Software Device Hazard Analysis.

  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.

  Please provide the Software Requirements Specification (SRS).

  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.

  Please provide a list of Hardware Requirements.

  Hardware requirements generally include:
    microprocessors (  RAM, hard drive size)
    memory devices
    sensors
    energy sources
    safety features

  Please provide the Software Design Specification (SDS).

  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.

  Please provide the Traceability Analysis.

  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.

  Please provide the Software Development Environment Description.

  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.

  Please provide Verification and Validation (V&V) Documentation.

  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.

  Unresolved Anomalies (Bugs or Defects)

  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)

  How do you ensure data security while using the -------(b)(4)---------, your 
  secured internet site? This should also be addressed in the hazard analysis.
   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

 