By David Cassak
For much of the 1990s, though they shared billing as life sciences or medical technology sectors, medical devices and biotechnology...
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Convergent Calling: An Interview with Medtronic's Stephen Oesterle
Historic walls between the medical device and biotech sectors are coming down as medical devices incorporate more biologically-active agents as part of their therapy. That's good news for device companies since device technology in these combination devices is every bit as critical to their clinical success as the biologic.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
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