Regulatory Open Forum

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  • 1.  NDA to BLA Lot Distribution Reports

    Posted 14-Sep-2020 15:20
    We recently had a NDA that the FDA has deemed a BLA as of March 23rd. My understanding is that the Lot Distribution Reporting period would start as of the first day of the approved BLA. I know have someone else thinking that we would use the original NDA approval month/Day as the start of the reporting period. I have been trying to research this and have emailed the FDA with this question, I have not found anything or heard anyhting back. Does anyone know for sure which date would be used for the first LDR reporting period?

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    Jennifer Ameneiro
    Sr. Regulatory Labeling Specialist
    Blue Bell PA
    United States
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  • 2.  RE: NDA to BLA Lot Distribution Reports

    Posted 15-Sep-2020 07:08
    We also had our NDA transitioned to a BLA in March. Our FDA Project Manager confirmed that our anniversary date for reporting would remain the same as our original NDA approval date. Hope that helps!

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    Amanda Rennig
    QA/RA Manager
    Bethlehem PA
    United States
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    Original Message


  • 3.  RE: NDA to BLA Lot Distribution Reports

    Posted 15-Sep-2020 08:15
    The annual report I can understand staying the same. This would be for the Lot Distribution report, which is every 6 months. Now that we have to report the lots that are being sent out because it's a BLA, wouldn't it make sense that it would start at the time that the drug was deemed a BLA?

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    Jennifer Ameneiro
    Sr. Regulatory Labeling Specialist
    Blue Bell PA
    United States
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    Original Message


  • 4.  RE: NDA to BLA Lot Distribution Reports

    Posted 15-Sep-2020 11:13

    Under 21 CFR 600.81, it states that

    "(a) Reporting requirements. The applicant must submit to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors."

    Which would be under an approved biologics license application (BLA) (Which would be the time it was deemed BLA).

    Hope this helps (If required to present your argument). 

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    Jay Pathak
    Regulatory Affairs Specialist
    Murray UT
    United States
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    Original Message


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