White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA

Heather Antonovich : Mar 24, 2025 10:22:42 PM

Diagnostics
White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA

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Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA

Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA

Heather Antonovich : Mar 24, 2025 10:22:43 PM

In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss...

Diagnostics IVD
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A Virtual Tutorial on Regulatory Pathways for Diagnostic Tests in the US and Europe

A Virtual Tutorial on Regulatory Pathways for Diagnostic Tests in the US and Europe

Veranex : Mar 24, 2025 10:22:44 PM

In this webinar, experts from Goldbug Strategies and Veranex discuss available regulatory pathways for bringing a new generation of innovative...

Commercial Strategy & Market Access
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Medicare Clarifies Confusion Over Tests Covered by the NGS NCD

Gary Keeler : Mar 24, 2025 10:23:13 PM

The Medicare NGS NCD grants national coverage for somatic testing in patients with advanced cancer if the test has FDA-approval or -clearance as a...

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