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    Home > Medical News > Latest Medical News > Notice on the public solicitation of opinions on the Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs

    Notice on the public solicitation of opinions on the Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs

    • Last Update: 2022-10-02
    • Source: Internet
    • Author: User
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    Notice on the public solicitation of opinions on the Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs
    Release date: 20220915

    The development of biopharmaceutical technology has promoted the rapid development of antibody-conjugated drugs, especially in the field of tumor treatment, and the research and development of antibody-conjugated anti-tumor drugs has continued to grow


    In order to make suggestions on the issues requiring special attention in the clinical research and development of antibody-coupled anti-tumor drugs, and to guide enterprises to carry out more scientific clinical research and development, the Drug Evaluation Center organized and wrote the "Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs", forming a draft for comments for the reference


    We sincerely welcome all sectors of the community to put forward valuable comments and suggestions on the draft for comments, and timely feedback to us for follow-up improvement


    Please send your feedback to the email address of the following contact:

    Contact: Charlene, Song Yuanyuan

    Contact: xialin@cde.


    Thank you for your participation and great support


    Drug Evaluation Center of the State Drug Administration

    September 15, 2022

    The development of biopharmaceutical technology has promoted the rapid development of antibody-conjugated drugs, especially in the field of tumor treatment, and the research and development of antibody-conjugated anti-tumor drugs has continued to grow


    In order to make suggestions on the issues requiring special attention in the clinical research and development of antibody-coupled anti-tumor drugs, and to guide enterprises to carry out more scientific clinical research and development, the Drug Evaluation Center organized and wrote the "Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs", forming a draft for comments for the reference


    We sincerely welcome all sectors of the community to put forward valuable comments and suggestions on the draft for comments, and timely feedback to us for follow-up improvement


    Please send your feedback to the email address of the following contact:

    Contact: Charlene, Song Yuanyuan

    Contact: xialin@cde.


    Thank you for your participation and great support


    Drug Evaluation Center of the State Drug Administration

    September 15, 2022

    Related Attachments

    serial number The attachment name
    1 Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).


    serial number The attachment name
    1 Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    pdf
    2 The feedback form of the "Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Comments)" .
    docx
    3 The drafting instructions for the technical guidelines for the clinical development of anti-tumor antibody conjugated drugs (draft for comments) .
    pdf
    Serial Number Attachment Name Serial Number Attachment Name Serial Number Attachment Name 1 Technical Guidelines for the Clinical Development of Antitumor Antibody Conjugated Drugs (Draft for Comments).
    pdf 2 Technical Guidelines for the Clinical Development of Anti-Tumor Antibody Conjugated Drugs (Draft for Comment) Feedback Form .
    docx 3 Technical Guidelines for the Clinical R&D of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    pdf 1 Technical Guidelines for the Clinical R&D of Anti-tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    pdf 11 Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Comment).
    pdf Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Comment).
    pdf Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Comment).
    pdf 2 Feedback Form for the Clinical R&D of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments) .
    docx 22 Feedback Form for the Clinical R&D of Anti-Tumor Antibody Conjugated Drugs (Draft for Comment)Feedback Form .
    docx Feedback Form for the Clinical R&D of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    docx Feedback Form for the Clinical R&D of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    docx 3 Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    pdf 33 Technical Guidelines for the Clinical Development of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments)Drafting Instructions.
    pdf Drafting Instructions for the Clinical Development of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    pdf Drafting Instructions for the Clinical Development of Anti-Tumor Antibody Conjugated Drugs (Draft for Solicitation of Comments).
    pdf
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