FDA 肿瘤药物咨询委员会（ODAC） 与细胞组织基因治疗咨询委员会（CTGTAC）的比较
其他
2024-09-13 22:14 作者:   积风
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FDA总共有31个咨询委员会（https://www.fda.gov/advisory-committees）

     • Blood, Vaccines and Other Biologics ：5 小组，含 CTGTAC（Cellular, Tissue, and Gene Therapies Advisory Committee)

     • Human Drug Advisory Committees ：18 小组，含 ODAC（Oncologic Drugs Advisory Committee)

     • Other

以下为ODAC与CTGTAC章程的比较：除了涉及领域、负责部门、开会频率有差别，其他基本相同。PS:本身ODAC与CTGTAC也会存在交叉，例如前段时间针对两款BCMA CAR-T产品召开的是ODAC。

　 Charter of Oncologic Drugs Advisory Committee(ODAC)   Charter of the Cellular, Tissue and Gene Therapies Advisory Committee
OBJECTIVES AND SCOPE OF ACTIVITIES advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the FDA has regulatory responsibility.
DESCRIPTION OF DUTIES The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. The Committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner of Food and Drugs.
AGENCY OR OFFICIAL TO WHOM THE COMMITTEE REPORTS The Committee provides advice to the Commissioner of Food and Drugs.
SUPPORT Management and support services shall be provided by the CDER Management and support services shall be provided by CBER
DESIGNATED FEDERAL OFFICER FDA will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration Manual directives.  
ESTIMATED NUMBER AND FREQUENCY OF MEETINGS Meetings shall be held approximately 4-6 times a year.   Meetings shall be held approximately 2 times a year.
DURATION Continuing
TERMINATION Committee will terminate two years from the date the charter is filed.
MEMBERSHIP AND DESIGNATION A core of 13 voting members including the Chair. 
Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunology oncology, biostatistics, and other related professions.  		 A core of 13 voting members including the Chair.
Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation (biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics. 
Members will be invited to serve for overlapping terms of up to four years. 
The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. 
In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests.  There may also be an alternate industry representative.
SUBCOMMITTEE Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise. 
Subcommittees make preliminary recommendations to the full Committee regarding specific issues for subsequent action by the full Committee.  The Department Committee Management Officer shall be notified upon establishment of each subcommittee, and shall be provided information on its name, membership, function, and estimated frequency of meetings.  Subcommittees must report back to the parent committee and must not provide advice or work products directly to the agency
RECORDKEEPING Records will be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.