The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
FDA Review Patterns of De Novo Submissions
The objective of this analysis was to assess whether timelines associated with the De Novo Process are in line with FDA’s stated goals.
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