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# Guidance on REMS Testing During Virus Outbreak
- URL: https://www.fdaweb.com/guidance-on-rems-testing-during-virus-outbreak/
- Published: 2020-03-23T12:00:00.000Z
- Updated: 2026-09-14T16:08:19.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146390

FDA has released a [guidance](https://www.fda.gov/media/136317/download?ref=fdaweb.com) entitled “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.” The document addresses the limited number of drugs that are subject to a REMS that requires laboratory testing ( e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging). FDA says it recognizes that during the coronavirus outbreak REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and subject to quarantine. “Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus,” the guidance says. “For drugs subject to these REMS with laboratory testing or imaging requirements, health care providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during the PHE, and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.”