Laboratorios Rovi : FDA set Risvan’s target date for July, as expected
>FDA has notified Rovi that the user fee goal date for Risvan is 27 July 2023 - Rovi reports that it has now filed the final responses to the Complete Response Letter received from the FDA in Q3 2022. These responses likewise included the answers of one of Rovi’s suppliers to outstanding questions. The FDA has notified that the user fee goal date is 27 July 2023. Likewise, Rovi has now filed the final report on correction of the deficiencies noted when the FDA inspect...Laboratorios Farmaceuticos Rovi is engaged in the sale of its own pharmaceutical products and the distribution of other products for which it holds licenses granted by other laboratories for specific periods, in accordance with the terms and conditions contained in the agreements entered into with said laboratories.
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