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General Forum, page-1059

  1. 562 Posts.
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    @Quiltman, I couldn't find the data you posted, and can't recall if it was recent/2023 data.

    The FDA has published approval data for 2023. 505 Approvals have been made, ranging from 2 days to 859 days for approval.
    The data doesn't state is whether Interactive Review or Additional Information Requests paths were taken :/
    - Average time to approve 161 days,
    - 60% approved within 200 days.
    - 80% approved within 269 days (98 applications took more than 270 days)
    https://hotcopper.com.au/data/attachments/5157/5157897-e513b999199f7ba15edf88264b717ecb.jpg



 
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