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BioWorld - Friday, December 26, 2025
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Home » Panel hears contrasting narratives from FDA, industry on paclitaxel
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Panel hears contrasting narratives from FDA, industry on paclitaxel

June 20, 2019
By Mark McCarty
The first day of a two-day U.S. FDA advisory hearing on the use of paclitaxel devices for the lower limbs was a study in different narratives. The FDA said five-year mortality was higher for drug-coated balloons (DCBs) and stents, despite the agency's seeming inability to establish any causative factor. Device makers received some support from the clinical community in the criticism of the FDA analysis and the journal article that started the conversation on several points, including that the clinical studies in question were not designed to evaluate mortality at five years.
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