PNV 2.35% $2.61 polynovo limited

6 months, page-13

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    GRAS in the US (the only place I know of that uses this specific terminology) is reserved for nutritional substances, i.e. they are eaten - taken by mouth. GRAS does not have any application to medical devices.

    Nevertheless, your point is otherwise valid as much underlying research on safety, pharmacokinetics, etc. should not need to be reinvented from scratch. The research will, however need to be resubmitted with each new application.
 
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