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  • 1.  CBER Pre-IND meeting lead time?

    This message was posted by a user wishing to remain anonymous
    Posted 24-Mar-2023 08:19
    This message was posted by a user wishing to remain anonymous

    Hello, Could you please respond if you have experience with pre-IND meeting request with CBER - what was the timeframe between when the pre-IND meeting is requested to when it is granted (meeting date)?

    I heard there is a long lead time - is that your recent experience.  Is CBER is not keeping up with timeframe in FDA's meeting guidance (i.e. 60 days for type B)?

    Also, for Pre-IND briefing book/Pharmacology studies  - is a single species ok? and do the studies have to be GLP?

    Thanks in advance!



  • 2.  RE: CBER Pre-IND meeting lead time?

    Posted 29-Mar-2023 02:19
    Edited by Prabhakar Parlapalle 29-Mar-2023 02:47



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    Prabhakar Parlapalle
    Bengaluru
    India
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    Original Message


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