Regulatory Support for Cancer Prevention Agent Development

该项目提供行政、技术、信息和监管资源和专业知识，以支持癌症预防部门(DCP)化学预防药剂开发计划的监管事务职能。监管联络人制定和实施访问、审查和汇编科学、安全和临床数据的程序，以便可能包括在lnds和其他监管提交的文件中。提交的监管文件符合FDA法规、ICH(国际协调委员会)指南、NIH、NCI和DCP要求以及其他相关法规、法律和指南。 这项任务主要涉及准备和向美国食品和药物管理局提交研究用新药申请(IND)。提交的文件还将包括药品主文件(DMF)、新药申请(NDA)、为技术支持承包商开发调查人员手册提供不良事件数据、通用技术文件和FDA法规要求的其他文件。对于由DCP支持的跨国研究工作，承包商可能会被指示准备提交给国际监管机构的文件。

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.