Orphan Drug Designation For Remdesivir Is 'Consistent' With Precedent, Former FDA Lawyer Says
Attorney who drafted Orphan Drug Act implementing regs says companies need incentive to develop a treatment that may not be available until crisis passes; KEI is mulling citizen petition to request revocation of the designation for Gilead's investigational COVID-19 product.
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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.
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.
Pivot from individual- to multi-patient protocols for expanded access may help generate data to inform regulatory filings and even payer determinations for Gilead’s potential COVID-19 treatment.