A., Fong, G
Therefore, while a product approved under an EUA and for which there is data reflecting the costs of the technology prior to FDA approval may be factually distinct from a product for which there is a documented delay in marketing availability following FDA approval, we disagree that beginning the newness period on the date of EUA issuance and prior to FDA approval would be inconsistent with our longstanding policy of beginning the newness period with the availability of the product on the U.S
The product has tremendous momentum, displacing Juul in the US and driving almost a billion dollars of revenue for the company
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