Revised guidance on Covid-19 symptom assessment incorporates new knowledge, adds flexibility

BY RACHEL COE, MSC

This week, the FDA revised its guidance on assessing symptoms in outpatients in clinical trials for products intended to treat or prevent Covid-19. This update – the first since its initial publication in almost four years – reflects the significant gains in knowledge that have occurred in that timeframe. With this publication, the FDA has only one remaining Covid-19-related guidance document that still awaits revisions.

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