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Harmonization in Plain Sight. Are FDA and CE Substantially Equivalent?

Medical device harmonization continues to struggle, with substantial differences between FDA and Europe continuing to be an obstacle. However, current changes in Europe and proposed changes in the US may...
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FDA gives thumbs up to digital submissions

In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail...

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