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Over The Counter Drugs (OTC) Laboratory Developed Tests

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McDermottPlus Check-Up: October 6, 2023

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THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Wilson Sonsini Goodrich & Rosati

FDA Reaches Another Milestone in COVID-19 Diagnostic Testing: First Over-the-Counter COVID-19 Home Test

On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

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