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US FDA Remains Concerned About OTC Access To COVID-19 Tests After It Allows First 'At-Home' Use

Executive Summary

OTC access to any test to diagnose COVID-19 without supervision by a health care professional isn't on the near-term horizon for potential launches in the US. In addition to diagnostic kits, digital apps available to directly to consumers for COVID-19 testing on their own would face a steep climb to approval.

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