Regulatory Open Forum

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  • 1.  Nonclinical data in SEND format

    Posted 14-Nov-2018 12:09
    Dear Colleagues,

    Is submission of nonclinical data in the SEND format required for Canada and Australia or is it only for the US FDA?

    Thank you.

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    David Lucking
    FL
    United States
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  • 2.  RE: Nonclinical data in SEND format

    Posted 15-Nov-2018 07:25
    ​Nonclinical data in SEND format is required for US only.

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    Olga Valentin-Alfieri RAC
    Director, Global Submissions Management (GRO)
    Franklin Lakes NJ
    United States
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