Regulatory Open Forum

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  • 1.  SEND data

    Posted 31-Jan-2012 09:15
    As we are preparing an NDA for the end of the year, I would like to know if CDER has adopted SEND data or if it is still at the pilot stage? Thanks.
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    Clarisse Stone RAC
    Manager, Electronic Documents
    Galderma R&D
    Cranbury NJ
    United States
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  • 2.  RE:SEND data

    Posted 02-Feb-2012 07:03
    Clarissa,

    As per the FDA website (http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155320.htm),

    CDER currently supports SEND IG v3.0 for regulatory submissions of tabulated toxicology data in electronic format provided that a complete study report is also submitted. Sponsors should see the continue to consult the Study Data Standards for Submission to CDER website4 for additional information including Study Data Specifications

    Hope that helps,
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    Sandhya Shankarnarayan PhD RAC
    Germantown MD
    United States
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