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Labs and Industry Stakeholders Respond to FDA LDT Rule

Explore the response to the FDA's Laboratory Developed Tests, LDTs, final rule, including industry concessions, legal challenges, and legislative reactions. ....

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United States - Life Sciences, Biotechnology & Nanotechnology - FDA Provides Updates To Congress On FDORA, User Fee Implementation

FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements. ....

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Opportunities & Challenges of Digital Pathology Adoption in CDx Development

In the dynamic world of life sciences, digital pathology stands out as a beacon of innovation, promising transformative changes in how pathologists engage, evaluate, and collaborate. ....

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FDA Roundup: May 7, 2024

FDA Roundup: May 7, 2024
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Orchard Software's Solutions Provide Support for Labs That Perform LDTs, Now Under FDA Oversight

/PRNewswire/ In response to the April 29th U.S. Food & Drug Administration (FDA) Final Rule 21 CFR Part 809 Medical Devices: Laboratory Developed Tests. ....

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