DeZwarteRidder schreef op 23 september 2020 07:24:
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“The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorized by the Agency in July. T
ragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalized in centers that do not allow patients access to investigational drugs,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, “Our staff is working around the clock to address requests for RLF-100™ under the appropriate mechanism.
All too often, patients of color and those of lower socioeconomic status are denied access.”FDA’s guidance to industry identifies the criteria for EUA as safe and “may be effective,” in contrast to the far more stringent requirement of “safe and effective” required for traditional drug approval. EUA may only be granted in circumstances where the Secretary of Health and Human Services has declared a Public Health Emergency, as is true in the COVID-19 pandemic.