A Letter to File Deep Dive

Medtech Matters - En podkast av Medical Product Outsourcing - Tirsdager

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:While we’ve mentioned letter ...

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