Regulatory Open Forum

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  • 1.  FEI number - timing

    This message was posted by a user wishing to remain anonymous
    Posted 09-May-2022 10:08
    This message was posted by a user wishing to remain anonymous

    How far in advance of a new drug application submission can / should a sponsor request an FEI number? How long does it typically take to receive the FEI number once you apply?