Convener of Discussions on Medical Policy Issues Impacting Drug Development

影响药物研发的医疗政策问题讨论召集人

• 批准号: 9259556
• 负责人: Gregory W Daniel
• 金额: $ 60万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9259556
• 关键词: Convener; Discussions; Medical; Policy; Issues

The U.S. Food and Drug Administration (FDA) seeks to protect public health by ensuring that marketed medical products are safe and deliver meaningful benefits to patients. In order to respond to advances in basic biomedical research and product development, FDA is continually addressing novel technical, scientific, and programmatic challenges to ensure the timely approval of safe and effective therapies and to advance regulatory science. As part of this work, the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER) at FDA issued a request for applications to support convening activities that engage key stakeholders and the public on medical policy issues related to drug development, review, and postmarket safety surveillance. The primary objective of the cooperative agreement will be to convene diverse stakeholder groups in a series of activities on a range of technical, policy, and procedural issues to support OMP’s work in advancing medical policy and regulatory science. The Engelberg Center on Health Care Reform (the Center) at the Brookings Institution has a long history of collaborating with FDA to tackle challenging regulatory policy issues, and is ideally suited to support OMP’s work with its innovative convening approach built around scholarship, neutrality, leadership and experience with diverse stakeholder groups. Convening topics may include:  Expanding postmarket safety surveillance and postmarket evidence generation capabilities;  Enhancing regulatory science and methods to support expediting drug development;  Incentivizing development in critical areas of unmet medical need; and  Supporting the implementation of the new regulatory programs. Each project activity will be tailored to successfully tackle potentially controversial topics through agendas designed to focus on the critical issues, targeted presentations and panels which represent diverse views, and significant time allocated for productive discussions moderated by experienced leaders. The Center will conduct thorough background research to support convening activities by reviewing the relevant literature, conducting in-depth discussions with key experts, analyzing existing and emerging policies, and monitoring current trends and opinions on topics relevant to FDA’s mission and goals. To support effective and transparent communication and engagement with the public, the Center will develop and disseminate thorough, concise, and meaningful materials which will be available on the Brookings website.

美国食品和药物管理局（FDA）旨在通过确保上市的 医疗产品是安全的，并为患者带来有意义的益处。为了应对以下方面的进展， 基础生物医学研究和产品开发，FDA不断致力于新的技术，科学， 和方案挑战，以确保及时批准安全和有效的治疗， 监管科学作为这项工作的一部分，药物评价中心的医疗政策办公室（OMP） FDA的CDER（CDER）发布了一项申请，以支持召集活动， 主要利益相关者和公众就与药物开发、审查和 上市后安全性监督。 合作协议的主要目标是召集不同的利益攸关方团体， 就一系列技术、政策和程序问题开展活动，以支持办公室管理计划在推进 医疗政策和监管科学。恩格尔伯格医疗保健改革中心（该中心）， 布鲁金斯研究所与FDA合作应对具有挑战性的监管政策有着悠久的历史 问题，并非常适合支持办公室管理计划的工作，其创新的召集方法围绕 奖学金，中立性，领导力和与不同利益相关者群体的经验。会议主题可 包括以下步骤： 扩大上市后安全监督和上市后证据生成能力; 加强监管科学和方法，以支持加快药物开发; 鼓励在未得到满足的医疗需求的关键领域进行发展; 支持新监管方案的实施。 每个项目活动都将通过议程成功地解决可能有争议的主题 旨在重点关注关键问题、有针对性的发言和代表不同观点的小组讨论， 并分配大量时间进行富有成效的讨论，由经验丰富的领导人主持。该中心将 通过审查相关文献，进行全面的背景研究，以支持召集活动， 与主要专家进行深入讨论，分析现有和新出现的政策，并监测 与FDA使命和目标相关的主题的当前趋势和意见。支持有效和 透明的沟通和与公众的接触，该中心将开发和传播 全面、简洁和有意义的材料，这些材料将在布鲁金斯网站上提供。