Update on REMS-Required Testing During COVID-19 Pandemic - MPR

Update on REMS-Required Testing During COVID-19 Pandemic - MPR

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“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,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.

The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities

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FDA Relaxes Certain Lab and Imaging Test Requirements for REMS Programs During the COVID-19 Pandemic

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Update on REMS-Required Testing During COVID-19 Pandemic - MPR

Full article: Improving clozapine utilization will require continued advocacy, drug sponsor interest, and FDA support to address REMS issues