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Non-Lab Diagnostics: FDA Regulatory Considerations | MoFo Life Sciences

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As...

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Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests

Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests
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Multi-Cancer Diagnostic Tests Global Market Outlook Report 2024: Focus on Emerging Technologies - Fragmentomics and Tumor-Educated Platelets, Liquid Biopsy with Imaging Data Analysis

/PRNewswire/ -- The "Multi-Cancer Diagnostic Tests: Global Market Outlook" report has been added to ResearchAndMarkets.com's offering. Cancer is one of the...

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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2023 - Insurance News

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2023 - Insurance News
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A Final LDT Rule In April!? Will FDA Be Prepared? - Healthcare

With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule...

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In Comments to FDA, AdvaMed Maintains Support of Agency's Authority to Regulate LDTs

In Comments to FDA, AdvaMed Maintains Support of Agency's Authority to Regulate LDTs
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OncoCyte (OCX) Begins FDA Submissions Process for VitaGraft Transplant Assays

OncoCyte (OCX) Begins FDA Submissions Process for VitaGraft Transplant Assays
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Using automated liquid handling for efficient lab developed testing

This article discusses how automated liquid handling can be utilized for efficient laboratory developed testing.

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Non-binding Guidance: FDA's Proposed Rule On Laboratory Developed Tests (Podcast) - Healthcare

Hi, I'm Greg Levine, head of the life sciences regulatory and compliance practice group in Ropes & Gray's Washington, D.C. office.

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