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  • 1.  Foreign Sites Under IND

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2022 08:59
    This message was posted by a user wishing to remain anonymous

    To be or not to be (under the IND) that is the question.
    We are getting ready to start up a global (US & EU sites) study.   If we include the non-US sites as IND sites we would request an IRB waiver and signed 1572 waiver per the May 2021 1572 FAQ.  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-sheet-guidance-sponsors-clinical-investigators-and-irbs-frequently-asked-questions

    What are the pros and cons of including the foreign sites under the IND?

    Does this make it easier at time of Marketing Application and if so how?

    Thank you in advance


  • 2.  RE: Foreign Sites Under IND

    Posted 09-Feb-2022 13:35
    At this point, I do not see any "pro" for including foreign sites under an IND. I have gone thru BIMO inspections for foreign sites that were not submitted to the IND without any comment from FDA that we were in some way non-compliant. We provided documentation that the studies were conducted according to GCPs.

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


  • 3.  RE: Foreign Sites Under IND

    This message was posted by a user wishing to remain anonymous
    Posted 20-May-2022 09:51
    This message was posted by a user wishing to remain anonymous

    HI Glen,

    would you expand your comment? were you working on a Phase 3 trial and your sites were found to be non-compliant? Were those under your IND and those same sites, when not under an IND, didn't have compliance issues when inspected?
    Original Message


  • 4.  RE: Foreign Sites Under IND

    Posted 20-May-2022 10:21
    Hi - I have had two different Phase 3 programs with foreign sites that were not submitted to the IND. FDA inspected several foreign sites and did not make any compliance observation regarding the fact that they were not filed to the respective INDs. We are currently conducting a Phase 3 program and our global CRO agreed 100% with this approach to foreign sites.

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


  • 5.  RE: Foreign Sites Under IND

    Posted 20-May-2022 13:23
    Let me further clarify, all sites for a registration study must comply with FDA/GCP/ICH compliance requirements. If one of your non-IND sites enrolls large number of patients I can almost guarantee that particular site will be inspected for all the applicable compliance regulations! Not including a site under an IND is not a non-compliant issue and there is no regulation that says you must include sites under IND for a registration P3 trial. For a real example, a big pharma company conducted entire registration study in an Asian country under non-IND but made sure that those sites were prepared adequately (with lot of expenses which this big pharma had no problems with) to ensure that they pass FDA inspection when occurred since the NDA was submitted to the FDA. So any site for a registration study must comply with applicable compliance requirements! No exceptions.
    Good luck!

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    GRSAOnline
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    Original Message


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