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Changing Times Raise Barriers to Device Innovation

Executive Summary

While legal considerations play a role in determining if or how soon use of a medical device is adopted, other factors are now just as important and in some cases more important in influencing a provider’s product selection process.

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Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

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