FDA CBER 2015自然年指南计划

julia朱玉姣

血液类专业不是很懂，术语不准确请见谅


GMP News
12/08/2015

CBER Guidance Agenda - Scheduled activities for 2015

CBER指南计划-----2015年计划的活动

On 1 July, the US FDA CBER published a list of guidance topics which should be developed during the calendar year 2015.The list includes topics that currently have no guidance associated to them, topics where updated guidances may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following the review of public comments. The following topics were included:

7月1日，美国FDA CBER公布了2015自然年要研发的指南主题。清单中包括现在还没有指南的主题、要更新的主题，以及CBER已发布第一层草案需要征求公众意见后定稿的主。其中包括以下主题：

CATEGORY – Blood and Blood Components: 类别---血液制品和血液成分物

• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry (published)
• 修订后降低血液和血液制品传播HIV风险的建议，指南草案（已公布）
• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Final Guidance for Industry
• 修订后降低血液和血液制品传播HIV风险的建议，行业指南终稿
• Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry
• 献血者适当性评估、献血延期和血液制品应对艾博拉病毒的管理建议，行业指南草案
• Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture; Draft Guidance for Industry
• 单采血浆用于进一步生产时再标签，行业指南草案
• Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Final Guidance for Industry
• 用于输血和移植配型的基于核酸的人类白细胞抗原（HLA）测试盒上市前通知（510K）注册建议，行业指南终稿
• Recommendations to Reduce the Risk of Transfusion-transmitted Chikungunya Virus (CHIKV); Draft Guidance for Industry
• 降低输血传染基孔贡亚病毒（CHIKV）的建议，行业指南草案
• Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability
• 通过采血场所和输血服务进行细菌检出测试增强安全性和可获得性
• Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Final Guidance for Industry2
• 修订后减少通过血液和血液制品传播克雅氏病和病毒型克雅氏病风险的预防措施，行业指南终稿
  

CATEGORY – Cellular, Tissue, and Gene Therapy: 类别---细胞组织和基因治疗

• Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Final Guidance for Industry (published)
• 细胞和基因治疗药品早期临床试验的设计中的考量，行业指南终稿（已公布）
• Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral Microbial Products; Final Guidance for Industry (published)
• 基因治疗、载体疫苗，和相关重组病毒微生物产品环境评估需求和内容确定，行业指南终稿（已公布）
• Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Draft Guidance for Industry (published)
• 受公众卫生服务法案第361部分单独管理及21CFR第1271管理的人类细胞、组织和基于细胞组织的药品（HCT/Ps）的不良反应调查和报告，行业指南草案（已公布）
• Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry3
• 人类细胞、组织和基于细胞组织的药品的同源性使用，行业指南草案
• Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry
• 用于基因治疗的微生物载体建议，行业指南草案
• Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema Pallidum (Syphilis); Final Guidance for Industry
• 人细胞、组织捐献者测试，基于细胞和组织治疗苍白密螺旋体（梅毒）感染的药品测试，捐献者筛选测试的使用，行业指南终稿
• Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Final Guidance for Industry
• 基于病毒或细菌的基因疗法和溶瘤细胞药的脱落研究设计和分析，行业指南终稿
• Use of Nucleic Acid Tests to Reduce Transmission of West Nile Virus from Donors of HCT/Ps; Final Guidance for Industry
• 使用核酸测试降低来自HCT/Ps捐献者的西尼罗病毒传播，行业指南终稿
  

CATEGORY – Other: 类别—其它

• Electronic Submission of Lot Distribution Reports; Final Guidance for Industry (published)
  

批销售报告电子提交，行业指南终搞（已公布）