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.”...