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  • 1.  conversion of old BLA format to CTD

    Posted 18-Aug-2014 10:37
    I need to convert an old format BLA into CTD format. Does anyone know where I can find a template or mapping system to facilitate this conversion?

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    Joanne Totosy de Zepetnek PhD
    Associate Deputy Director, Regulatory Affairs
    MassBiologics
    Boston MA
    United States
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  • 2.  RE:conversion of old BLA format to CTD

    Posted 19-Aug-2014 06:31
    The Comprehensive TOC Headings and Hierarchy contains the mappings

    http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf

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    Michelle Mc Guinness
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    Original Message


  • 3.  RE: conversion of old BLA format to CTD

    Posted 19-Aug-2014 08:39
    Joanne,

    FDA's comprehensive eCTD granularity is here http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM315023.pdf.

    Is this what you meant/wanted?

    Best regards,
    Chris

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    Christopher Webster MS, PHD
    Acton MA
    United States
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    Original Message


  • 4.  RE: conversion of old BLA format to CTD

    Posted 19-Aug-2014 09:47
    The FDA guidance "eCTD Table of Contents Headings and Hierarchy" starting on page 17 maps the NDA/BLA requirements to the CTD sections.

    Here is the source website:
    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm

    The document:

    eCTD CTOC

    FDA eCTD Table of Contents Headings and Hierarchy14

    07/05

    You would still need to break down and combine each NDA/BLA Section into each CTD Module.

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    Thomas Christensen RAC
    Inventivhealth
    Apex NC
    United States
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    Original Message


  • 5.  RE: conversion of old BLA format to CTD

    Posted 19-Aug-2014 16:18
    Joanne,

    I have found this link useful:

    http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM270304.pdf

    Also, there are many operational CROs that can perform this exercise fairly quickly and efficiently. 

    Good luck, 

    Dar
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    Darlene Rosario RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 6.  RE: conversion of old BLA format to CTD

    Posted 19-Aug-2014 17:14
    Please be aware of the recent changes/updates to eCTD/CTD at http://wp.me/p4xpOK-jY

    Please note:  updates made on Feb 7, 2014 and the recent guidance document, July 2014.

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    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message