Cutting Regulatory Red Tape News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19).
An EUA differs from an approval in that the statutory standard to receive an EUA is lower than the standard to receive approval. Sponsors may seek approval of medical products at any time. For an EUA, there must be some condition or event to rationalize emergency use of a medical product. Importantly, receiving an EUA does not mean that a product is FDA “approved.” An EUA allows for the temporary marketing of a medical product during an emergency (the COVID-19 public health emergency, in this case). For continued marketing after the COVID-19 public health emergency ends, manufacturers will need to receive a full approval or clearance from the FDA. ....

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