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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 | ||||||||
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1 | Technical Guidelines for the Clinical Development of Anti-tumor Antibody Conjugated Drugs (Draft for Solicitation of 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).
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