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  • 1.  FDA PLI/PAI inspections for BLA/NDA

    Posted 21-Jul-2020 17:08
    Fellow professionals,

    Any recent experiences or feedback on FDA’s COVID-19 mitigation strategies towards pre-license inspections or pre-approval inspections for novel biologics or drugs?

    Your feedback will be much appreciated!

    Thanks,
    Deep

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    Deep Shah, MS
    Global Regulatory Affairs CMC
    Seattle, WA
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  • 2.  RE: FDA PLI/PAI inspections for BLA/NDA

    Posted 22-Jul-2020 07:49
    On July 10, FDA issued a notification that domestic, mission-critical inspections would resume. The inspections are still based on COVID-19 activity at the location and FDA is using a scoring system based on cases on a national and county basis. There is some discussion that they are using a risk-based approach taking into account the novelty of the manufacturing process, the need for the product, and history of the manufacturer. In some cases, FDA is using its record request authority to request documents to review and could make a decision not to conduct an on-site inspection under this discretionary authority - although doing so does not qualify as an "inspection." To my knowledge, FDA has not published an approach to foreign inspections.

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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: FDA PLI/PAI inspections for BLA/NDA

    Posted 22-Jul-2020 09:20
    FDA just announced they are "restarting domestic inspections" but they haven't said much about their mitigations for how to do them safely, or how they will handle companies that are largely working remote etc. If the manufacturing facility making your product is outside the US, it is probably worth a call to discuss how they intend to handle pre-approval inspection requirements. It seems like external travel is going to take a while, and I can't imagine they really want to delay things indefinitely.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: FDA PLI/PAI inspections for BLA/NDA

    Posted 23-Jul-2020 16:06
    Many thanks for the feedback, Glen and Ginger.

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    Deep Shah, MS
    Global Regulatory Affairs CMC
    Seattle, WA
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    Original Message


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