Regulatory Open Forum

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  • 1.  Issue of Pre-assigned IND Number

    Posted 02-Jul-2019 16:53
    ​Has anyone noticed delay or issues with pre-assigned IND number assignment using the FDA email CDERAPPNUMREQUEST@fda.hhs.gov? I have requested an IND number last week Wednesday and still have not heard back. Any suggestion on how to follow up or who should I follow up with?

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    Kala Patel RAC
    Princeton NJ
    United States
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  • 2.  RE: Issue of Pre-assigned IND Number

    Posted 03-Jul-2019 08:07
    I have never had it take more than a day or two, but it has been a year since my last one. If you submitted from a secure email and used the correct email address, I would first check your junk mail, and if not there ... I would try sending a followup query to the email as it seems something has gone awry along the way. Note that there is now a web portal for requesting numbers: CDER NextGen Portal.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Issue of Pre-assigned IND Number

    Posted 03-Jul-2019 13:46
    ​Hi there,
    Generally, delays aren't noticed with pre-assigned IND number assignment. 
    After double checking the email address and your outbox to ensure it was delivered, I would send a follow-up by email or call CDER at 1-888-463-6332/1-888-INFO-FDA.


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    Saleha Ripa
    Regulatory Project Coordinator
    Rtp NC
    United States
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    Original Message


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