Regulatory Support for Cancer Prevention Agent Development

癌症预防剂开发的监管支持

• 批准号: 8550728
• 负责人: CAROLINE C SIGMAN
• 金额: $ 195.45万
• 依托单位: CCS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2018-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8550728
• 关键词: Adverse event; Agreement; Area; Chemopreventive Agent; Clinical Data; Contractor; Data; Development; Division of Cancer Prevention; Documentation; Guidelines; Informatics; International; Investigational New Drug Application; Laws; Maintenance; Management Information Systems; Pamphlets; Pharmaceutical Preparations; Preparation; Procedures; Process; Program Development; Records; Regulation; Regulatory Affairs; Reporting; Research; Research Personnel; Resources; Safety; United States Food and Drug Administration; United States National Institutes of Health; cancer prevention; meetings

This project provides administrative, technical, informatics and regulatory resources and expertise to support the regulatory affairs functions for the Division of Cancer Prevention (DCP) chemopreventive agent development program. The regulatory contactor develops and implements procedures for accessing, reviewing, and compiling scientific, safety, and clinical data for possible inclusion in lNDs and other regulatory submissions. Regulatory submissions are made in accordance with FDA regulations, ICH (International Committee on Harmonization) guidelines, and NIH, NCI, and DCP requirements and other relevant regulations, laws, and guidelines. Primarily this task involves the preparation and submission of Investigational New Drug Applications (INDs) to the U.S. Food and Drug Administration. Submissions will also include Drug Master Files (DMFs), New Drug Applications (NDAs), providing adverse event data for development of the Investigator's Brochures by the Technical Support contractor, Common Technical Documents, and other documents required by FDA regulations. For multinational research efforts supported by DCP, the contractor may be directed to prepare submissions to international regulatory bodies.

该项目提供行政、技术、信息学和监管资源和专业知识，以支持癌症预防司（DCP）化学预防剂开发计划的监管事务职能。监管联系人制定并实施访问、审查和编辑科学、安全性和临床数据的程序，以便可能纳入IND和其他监管提交文件中。根据FDA法规、ICH（国际协调委员会）指导原则、NIH、NCI和DCP要求以及其他相关法规、法律和指导原则进行监管申报。 这项任务主要涉及准备和向美国食品药品监督管理局提交研究性新药申请（IND）。提交文件还将包括药物主文件（DMF）、新药申请（NDA）、技术支持承包商提供的用于编制研究者手册的不良事件数据、通用技术文件以及FDA法规要求的其他文件。对于由数据收集程序支持的多国研究工作，可指示承包者编写提交国际管理机构的文件。