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首页> 外文期刊>Urologic oncology >Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology
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Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology

机译：食品药品监督管理局药品和放射性药物开发和批准程序：泌尿科肿瘤学治疗

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摘要

Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years. Published by Elsevier Inc.
机译：监管建议和评估在成功开发用于治疗泌尿系统恶性肿瘤的新药和放射性药物中起着重要作用。在过去的20年中，美国食品药物管理局（FDA）与制药行业之间的合作已导致批准了20多种新的泌尿科肿瘤学产品。尽管取得了这些进步，但仍需要开发和批准更有效的治疗泌尿系统恶性肿瘤的方法。这篇综述提供了有关FDA在研发新药方面的作用的一般信息，并着重于监管程序和市场批准的要求。此外，本综述总结了过去30年FDA批准的用于治疗泌尿系统恶性肿瘤的产品，以及在过去10年中在肿瘤药物咨询委员会会议上公开讨论的有关泌尿系统肿瘤产品的关键问题。由Elsevier Inc.发布

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