Regulatory Open Forum

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  • 1.  eCTD v4.0 timelines

    Posted 15-Mar-2018 14:51
    Dear Regulatory Affairs Professionals,
    I am interested to know about the next version of eCTD (version 4.0) timelines, how ICH and FDA  are going to implement the new version in Pharmaceutical and Biotech industries, about pilot program and also about mandatory implementation. If possible, please do provide the links to resources also.
    Thank you.

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    Srikanth Navuluri
    Rockville, MD
    United States
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