How Might FDA Letter Affect Roche, and What of Its Competitors? | GenomeWeb

At A Glance

Name: Ron Eisenwinter

Title: Consultant on FDA and regulatory issues, Boston Healthcare Associates-Expertech

Age: 49

Background: BS in cell biology and biochemistry from Boston University.


Steven Gutman’s July 8 letter to the chief of Roche Diagnostics is “pivotal,” and will set the tone for the way in which the agency views ASRs and other molecular diagnostics, according to many industry experts.

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