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  • 1.  Pre-submission review and meeting timelines

    This message was posted by a user wishing to remain anonymous
    Posted 06-Mar-2022 22:15
    This message was posted by a user wishing to remain anonymous

    Hi,

    Is it true that the FDA pre-submission review timelines are not being, that the meetings are rescheduled these days due to shortage of resources?

    thanks


  • 2.  RE: Pre-submission review and meeting timelines

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2022 15:46
    This message was posted by a user wishing to remain anonymous

    Hello,

    I am not sure I understand the question completely.  CDRH pre-submission meetings are occurring, but they are taking longer to get scheduled than pre-COVID.  The latest experience within my organization for the past three pre-sub meetings we have done with our branch in CDRH since COVID started is that meeting are ~3.5-4 months after the pre-submission request was sent.  The meetings were not ever re-scheduled, but just scheduled quite a way out compared to prior pre-COVID experience. I am not sure if this is a similar experience across CDRH, or specific to our review branch.
    Original Message


  • 3.  RE: Pre-submission review and meeting timelines

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2022 15:50
    This message was posted by a user wishing to remain anonymous

    With my recent experiences (I have two pre-subs in review right now), the timelines have been kept as expected and meetings are scheduled on time.  I think it may be dependent on the specific review division though, as some areas may have diverted some of their resources to addressing pandemic research/approvals.
    Original Message


  • 4.  RE: Pre-submission review and meeting timelines

    Posted 10-Mar-2022 11:23
    Hi anon,

    My experience has varied between CDER and CBER. CDER generally has been on-time with pre-IND interactions, whereas many of the pre-IND interactions I've had with CBER since COVID began have been delayed by a few months; I've also heard stories from colleagues of pre-IND delays up to 3-4 months with CBER.

    I've also noticed some variability in which division is assigned to review applications within CDER. For instance, I have had three different divisions assigned to review applications for very similar products (i.e. same therapeutic class/mechanism of action). I think this reflects the resource re-allocation they've had to do in response to the pandemic. Hopefully things will stabilize as the pandemic wanes and congress authorizes new funding for FDA.

    Cheers,
    Marshall

    ------------------------------
    Marshall Hoke
    Director of Regulatory Affairs
    Lafayette CO
    United States
    ------------------------------

    Original Message


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