Research & Development
US FDA issues new guidance regarding certain Risk Evaluation and Mitigation Strategy testing during COVID-19
23 March 2020 -

The USFood and Drug Administration (FDA) has issued a new guidance to sponsors and healthcare providers regarding Risk Evaluation and Mitigation Strategy (REMS) required testing during the ongoing efforts to address the coronavirus pandemic, it was reported on Sunday.

FDA principal deputy commissioner, Amy Abernethy, MD, PhD, said, 'The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.'

For drugs subject to REMS with laboratory testing or imaging requirements, healthcare providers prescribing and/or dispensing these drugs should consider if there are compelling reasons not to complete these tests or studies during this public health emergency and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies. They should also communicate with their patients regarding these judgments including their benefits and risks. The policy outlined in the guidance will be implemented for the duration of the public health emergency.

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