Published in FDA Law Weekly, November 18th, 2004
In currently approved products, these devices (e.g., coronary stents) provide a primary function, with the drug contributing therapeutic benefit that improves patient outcomes.
Ongoing improvements in specialty coating platforms are expanding the number of active compounds are can be formulated as drug-device combination products.
"We expect the clinical results from the current generation of coated device designs to yield valuable insight that...
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Source: FDA Law Weekly (2004-11-18)
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