Individual Tumor Profiling
Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?
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Making the Most of Pre-IDE Meetings
With Proper Use these Get-Togethers Can Be Valuable Assets for IVD Companies
- In order to sell diagnostic devices in the U.S., in vitro diagnostic (IVD) manufacturers need to get marketing authorization from FDA. That raises an obvious question: How does a company know what data to submit and which regulatory pathway to use? One way is to ask FDA for ...
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