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


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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