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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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FDA Roundup: December 22, 2023

FDA Roundup: December 22, 2023
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510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

This draft guidance provides FDA’s current thinking on the 510(k) Third Party Review Program and review of EUA requests by third party review organizations.

Guidance issuing officeThird party review programDrug administrationRadiological healthSubmit commentsEmergency use authorizationPreview program

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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Nano-X: Next Few Quarters Will Be Critical For Adoption (NASDAQ:NNOX)

Nano-X: Next Few Quarters Will Be Critical For Adoption (NASDAQ:NNOX)
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