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    Home > Active Ingredient News > Drugs Articles > Notice on Publicly Soliciting Opinions on the "Technical Guidelines for the Design of Clinical Trials of Long-acting Granulocyte Colony Stimulating Factor Preventing Infection after Chemotherapy (Draft for Solicitation of Comments)"

    Notice on Publicly Soliciting Opinions on the "Technical Guidelines for the Design of Clinical Trials of Long-acting Granulocyte Colony Stimulating Factor Preventing Infection after Chemotherapy (Draft for Solicitation of Comments)"

    • Last Update: 2021-10-21
    • Source: Internet
    • Author: User
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    Neutropenia is a hematological toxicity related to bone marrow suppression caused by chemotherapy.
    The degree and duration of its reduction are closely related to the risk of infection and even death
    .


    Recombinant human granulocyte colony stimulating factor (rhG-CSF) has been on the market for many years as an effective drug to prevent and treat neutropenia caused by tumor radiotherapy and chemotherapy


    We sincerely welcome valuable comments and suggestions from all walks of life on the solicitation draft, and timely feedback to us for follow-up improvement
    .


    The time limit for soliciting opinions is 1 month from the date of publication


    Please send your feedback to the mailbox of the following contact:

    Contact: Zhang Hong

    Contact: zhanghong@cde.


    Thank you for your participation and great support


    Drug Evaluation Center

    October 11, 2021

    Appendix:

    1 "Long-acting Granulocyte Colony Stimulating Factor to Prevent Infection after Chemotherapy Clinical Trial Design Technical Guidelines (Draft for Solicitation of Comments)".


    "Long-acting Granulocyte Colony Stimulating Factor to Prevent Infection after Chemotherapy Clinical Trial Design Technical Guidelines (Draft for Solicitation of Comments)".


    "Technical Guidelines for the Design of Long-acting Granulocyte Colony Stimulating Factor to Prevent Infection after Chemotherapy (Draft for Comment)" Drafting Instructions.


    "Long-acting Granulocyte Colony Stimulating Factor Clinical Trial Design Technical Guidelines for the Prevention of Infection after Chemotherapy (Draft for Solicitation of Comments)" feedback form for soliciting opinions.
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