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    Home > Medical News > Latest Medical News > Yifan Pharmaceutical: FDA will delay approval of F-627 marketing application

    Yifan Pharmaceutical: FDA will delay approval of F-627 marketing application

    • Last Update: 2022-04-19
    • Source: Internet
    • Author: User
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    On March 31, Yifan Pharma released an announcement on the progress of the F-627 project, a product under development by its holding subsidiary


    ,

    The announcement shows that EviveBiotech Ltd.


    On March 30, 2021, Yiyi Bio, a holding subsidiary of the company, submitted the F-627 biological product license application (BLA) to the US FDA, and received the FDA's acceptance letter on May 27, 2021, agreeing to approve F-627 The target date is March 30, 2022


    The specific content of the FDA notification: "When reviewing the submitted F-627 application, we made it clear that before the FDA approves the F-627 marketing application, an on-site inspection of Yiyi Biopharmaceutical (Beijing) Co.


    Yifan Pharmaceutical stated that up to now, Yiyi Bio, a subsidiary of the company, has responded to all questions raised by the FDA during the technical review of F-627


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