Physician Awareness of FDA’s Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic

Hwang CS, Lu Z, Russo M, Zakoul H, Toyserkani GA, Zhou EH, LaCivita C, Dal Pan GJ, Kesselheim AS, Sarpatwari A - Drug Safety

  • Regulation and Clinical Evidence

Summary:

About half of surveyed physicians were aware of the FDA’s temporary policy during the COVID-19 pandemic that allowed clinicians to use medical judgment in place of certain REMS-required laboratory tests, and far fewer physicians reported changing their testing practices in response, often citing the perceived clinical importance of continued monitoring. Targeted, reinforced FDA communication may be needed to ensure clinicians receive and act on temporary policy changes moving forward.

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