Center for Research on Complex Generics

项目总结： 我们提出了一个复泛型研究中心(CRCG)，它将通过与 食品和药物管理局(FDA)和仿制药行业确定和组织以下活动 促进复杂仿制药的开发，包括更多的第一周期批准。CRCG将成为一门科学-- 基于资源，增加了FDA正在进行的仿制药办公室(OGD)活动，重点是复杂的 仿制药以及了解和促进复杂仿制药开发的机会。这一观点 反映了药物开发科学中的竞争前空间，包括复杂的 配方科学是需要公众积极参与的公共空间。我们将与最好的合作 内容专家推动药物开发科学，使更容易获得的药物向前发展。这个 CRCG的使命是支持FDA努力加强与仿制药的研究合作 行业推进FDA的使命，即增加获得安全有效的仿制药。这项任务将 通过合作研究、培训和交流来追求。利益相关者包括FDA，仿制药 工业，以及所有其他对更好的药物开发科学感兴趣的人，以便更容易获得 药物。活动包括网络研讨会、讲习班、试点实验室项目，以满足技术开发的要求 需求，实验室演示，访问科学家计划，以及复杂的泛型学者 课程和学生活动。这些活动的总和描述了一个充满活力的、前沿的中心，它刺激 创新思维，传播对复杂药物和实践的理解，并产生新的 支持FDA基本使命的知识--促进和保护公众健康。

Project Summary: We propose a Center for Research on Complex Generics (CRCG), which will serve the public by working with the Food and Drug Administration (FDA) and the generic drug industry to identify and organize activities that promote the development of complex generics, including greater first cycle approvals. CRCG will be a science- based resource that adds to ongoing FDA Office of Generic Drugs (OGD) activities, with a focus on complex generics and opportunity to learn about, and contribute to, complex generic drug development. This viewpoint reflects the perspective that pre-competitive spaces in drug development science, including complex formulation science, are public spaces that require active public involvement. We will work with the best content experts to move pharmaceutical development science for more accessible medicines forward. The mission of the CRCG is to support the FDA's efforts to enhance research collaborations with the generic industry to further the FDA's mission of increasing access to safe and effective generic drugs. This mission will be pursued through collaborative research, training, and exchange. Stakeholders include FDA, the generic industry, and all others with an interest in better pharmaceutical development science for more accessible medicines. Activities include webinars, workshops, pilot laboratory projects to meet technique development needs, laboratory demonstrations, a Visiting Scientist Program, as well as a Complex Generics Scholars program and student events. The sum of these activities describe a vibrant, cutting edge Center that stimulates innovative thought, disseminates understanding of complex drugs and practices, and generates new knowledge in support of the FDA's fundamental mission – to promote and protect the public health.