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Telehealth Flexibility: Key Regulatory Changes Impacting Providers During and Beyond the Coronavirus Pandemic - Diagnosing Health... [Video]

This Diagnosing Health Care episode focuses on the growing opportunity for providers to integrate telehealth into their practice through a compliant and forward-thinking approach. The episode is hosted by Megan Robertson and...more

FDA Authorizes the First Home Collection of Specimens to be Tested for COVID-19

As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. ...more

FDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests

On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist...more

FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic

On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more

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