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  • 1.  Protocol Synopsis in IND

    This message was posted by a user wishing to remain anonymous
    Posted 25-Feb-2021 17:13
    This message was posted by a user wishing to remain anonymous

    Dear RAPS community,

    Is it possible to submit an IND with a protocol synopsis instead of the full protocol ?
    At least temporarily, when submitting and then sending the full protocol before the end of the 30-day review by the FDA ?

    Thank you,
    All the best.


  • 2.  RE: Protocol Synopsis in IND

    Posted 26-Feb-2021 08:24
    I won't say an absolute no, but I will say that in my experience you will not save any time by delaying submission of a full protocol into the review period and will risk being put on clinical hold if the Agency does not feel they have had enough time to review the full protocol. Of course, it depends on the phase of study and how complete the synopsis is. A Phase 1 study synopsis that includes all of the components in sufficient detail to meet the requirements of 12 CFR 312.23 IND contents may be sufficient.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: Protocol Synopsis in IND

    This message was posted by a user wishing to remain anonymous
    Posted 26-Feb-2021 08:54
    This message was posted by a user wishing to remain anonymous

    NO! Unless you are prepared for a clinical hold until a full protocol is submitted.
    Original Message


  • 4.  RE: Protocol Synopsis in IND

    Posted 26-Feb-2021 08:57
    Sorry, I'd say No! The only time where a synopsis is ok is when you submit it for a FDA pre-IND meeting. Since you are mentioning a 30-day review period, it implies its a new IND first-in-human study therefore Full protocol is needed for the 30-day review period to pass else be prepared for clinical hold until your full protocol is submitted!

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    GRSAOnline
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    Original Message


  • 5.  RE: Protocol Synopsis in IND

    Posted 27-Feb-2021 08:05
    As everyone mentioned, a full protocol will be needed with 30 day review period and FDA should have sufficient time to review it.
    it is better to submit full protocol as submitting a synopsis would not save any time and may lead to a clinical hold.

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    Vasundhara Pathak
    Stratford PE
    Canada
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    Original Message


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