FDA forced to blur the lines on REMS due to COVID-19

The US Food and Drug Administration (FDA) has issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during what it calls the ‘public health emergency’ of the COVID-19 crisis.

Completing some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating or subject to quarantine, the agency admits.

Testing can risk transmission