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  • 1.  PADER exposure data

    Posted 20-Jan-2021 17:39
    ​​Dear Members,

     Quick question on presentation of exposure data in PADER- I am asked to update the PADER template for my company and I can see that there is one section on "Patient exposure" where the data on number of prescriptions written in US is updated with every reporting period.

    There is no mention of exposure data in Section 314.80 of Title 21 of CFR and the person who created the template is no longer in picture.

    Can anyone from his past/present experience explain whether this is required in a PADER or not? If yes, do you also calculate increase or decrease percentage comparing the numbers with previous reporting period?

    Thank you very much!



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    Garima Sharma
    Aggregate Reports Manager
    Mountain Lakes NJ
    United States
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  • 2.  RE: PADER exposure data

    Posted 21-Jan-2021 11:37
    Below is the link for current from the FDA to comply with PADER: I am confused with the exposure data being related to number of prescriptions written!!!! Probably this requirement was taken from the annual report regulations for each marketed drug. I don't think that this (i.e. # of prescriptions written) has anything to do with PADER requirements!

    https://www.fda.gov/media/85520/download

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    GRSAOnline
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    Original Message


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