Curetis Expects Near-Term FDA Decision on De Novo Request

The FDA and Curetis have agreed on software results screens and disclaimer language in the fourth quarter of 2017 and software implementation of the final reporting format is already underway. In December 2017, the FDA and Curetis also agreed on the format and scope of reporting of clinical and resistance marker data as part of the labelling .

Original published: 2018-01-08 10:52:24 Read the full Vienna News here

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