FDA easing some REMS requirements during pandemic
Taking into consideration how social distancing and shelter in place edicts may make it difficult for patients to visit a lab, FDA released guidance Monday easing Risk Evaluation and Mitigation Strategy requirements.
If a drug’s REMS requires laboratory testing or imaging studies, the agency advised that healthcare providers “use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.”
FDA said it will not take enforcement action against sponsors or others for accommodations made regarding laboratory testing or imaging study requirements.
Friday’s guidance follows recommendations from FDA Wednesday on how drug developers can adapt clinical trials to the pandemic by altering patient monitoring strategies, endpoints and other aspects of their protocols (see “FDA Stresses Patient Safety, Studies’ Integrity Amid Outbreak”).
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