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Home » No withdrawals, but paclitaxel will drive longer device studies
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No withdrawals, but paclitaxel will drive longer device studies

June 21, 2019
By Mark McCarty
The second day of the advisory hearing on paclitaxel devices for the lower limbs included additional pushback against analyses by the FDA and a medical journal article. However, the panel struggled to isolate a dose-response metric that would have lent credibility to the argument that mortality is higher on these devices. Consequently, the panel recommended longer follow-up in future studies of new devices, and sponsors of existing approvals will have to ratchet up their follow-up efforts.
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