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（DCP）化学预防剂开发项目的监管事务职能。监管联系人开发和实施程序，用于访问、审查和汇编科学、安全性和临床数据，以便可能包括在ind和其他监管提交中。根据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、法律和指南提交法规意见书。

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.