Gilead's Request To Revoke Remdesivir Orphan Designation Reflects Pandemic Pressures
Two days after US FDA granted remdesivir orphan status for treatment of COVID-19, Gilead told the agency it is unnecessary. EMA says it would not grant orphan drug designation to a COVID-19 treatment.
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EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.