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  • 1.  retention of test article samples

    Posted 13-Oct-2020 12:51
    Hello, Im studying for RACS exam and I have a question: retention of test articles are only require for BA/BA studies?, Can FDA request samples for biologics INDs or BLAs applications?
    Thanks

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    Monica Hall

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  • 2.  RE: retention of test article samples

    Posted 13-Oct-2020 13:00
    Hi Monica,

    There is  guidance in the link below re: this issue at the links below.  FDA can request IND BA/BE samples. There is not a current guidance re: part 612 and sample retention for a BLA. But, you could leverage the guidance below as the FDA's "current thinking" re: this issue. But I do not have experience to provide concrete feedback on that.

    https://www.fda.gov/media/71393/download

    https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/retention-bioavailability-and-bioequivalence-testing-samples. 


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    Ashley Clark RAC
    Gainesville FL
    United States
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    Original Message


  • 3.  RE: retention of test article samples

    Posted 13-Oct-2020 14:59
    Hi Monica, 

    Yes- FDA can request samples for biologics as well for INDs and BLAs. 21CFR 600, 610 and 612 addresses this requirement. CBER director may request this information However, the guidance does not offer much detail on the amount of samples etc. 
    I pulled together a table of the amount sufficient for retention at different stage- you can refer to that as well 
    table


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    Sai Prathyusha Bhamidipati
    Associate Director, Regulatory Affairs
    Medford MA
    United States
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    Original Message


  • 4.  RE: retention of test article samples

    Posted 13-Oct-2020 16:01
    Edited by Monica Hall 13-Oct-2020 16:02
    Thank you all for your help!
    Monica

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    Monica 
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    Original Message


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