FDA Partners With Health Canada On E-Submission Pilot

The pilot will allow manufacturers to use the same digital application format for regulatory consideration by both agencies. 

 Men shake hands against the background of the Canada and US flags.
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Manufacturers hoping to market their devices across North America would have one fewer application to complete under a new pilot program from the US Food and Drug Administration and Health Canada.

The joint eStar pilot, which was announced on 10 January, will test the feasibility of allowing sponsors to submit device applications to both agencies in the same eStar format....

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