Coronavirus (COVID-19) update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

FDA

22 March 2020 - Today, as part of the U.S. FDA’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain risk evaluation and mitigation strategy required testing during this time.

For drugs subject to a risk evaluation and mitigation strategy with laboratory testing or imaging requirements, healthcare providers prescribing and/or dispensing these drugs should consider whether 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.

Read FDA press release

Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , COVID-19