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  • 1.  FDA Clinical Inspections for NDA Efficacy supplement

    Posted 29-Apr-2021 16:05

    Hello,

    In the review process of an NDA supplement including a new clinical study, the FDA requested additional information for each clinical site in view of an inspection. At that stage, we are still waiting to hear back from the Office of Regulatory Affairs (inspection arm of ORA) in terms of details for this inspection, whether it will be virtually or on-site, and at the sponsor and/or clinical sites. 
    Do you have an idea of how long does it take from the time they inform us to the time of the inspection? Do we have several days/weeks to get organized in general?

    Also, anyone with experience of virtual inspections these days due to COVID and advice compared to in-person inspections?

    Thank you very much,

    Best Regards
    Charlene



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    Charlene Revel
    Senior Regulatory Scientist
    B&H Consulting Services, Inc. - ENTERPRISE
    Cambridge MA
    United States
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  • 2.  RE: FDA Clinical Inspections for NDA Efficacy supplement

    Posted 30-Apr-2021 10:30
    Hi ~
    I currently have BLA under review at CBER, and FDA did perform on-site inspections of a few clinical sites from the program.  They typically will announce the inspection about a week in advance.  Not sure if CDER is doing anything differently right now, but that's the CBER experience.
    Best Regards

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    Patrick Thomas
    Pfizer - ENTERPRISE
    Collegeville PA
    United States
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    Original Message


  • 3.  RE: FDA Clinical Inspections for NDA Efficacy supplement

    Posted 04-May-2021 06:48
    Our recent experience with CDER is that they will do on-site inspections of US sites but remote inspections for foreign sites. For the foreign remote inspections, we were notified about two weeks in advance to obtain certified copies of the clinical study records and the FDA investigator came to our office to view the records. For the US sites, notification was generally a week or less.

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


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