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FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics
April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro...
IVD (2)
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The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?
In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...
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Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany
Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in...