确保复方产品的安全性和有效性:监管挑战与最佳实践

Deepak Kumar Gupta, Akhilesh Tiwari, Yashraj Yadav, Pranay Soni, Megha Joshi
{"title":"确保复方产品的安全性和有效性:监管挑战与最佳实践","authors":"Deepak Kumar Gupta, Akhilesh Tiwari, Yashraj Yadav, Pranay Soni, Megha Joshi","doi":"10.3389/fmedt.2024.1377443","DOIUrl":null,"url":null,"abstract":"Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.","PeriodicalId":12599,"journal":{"name":"Frontiers in Medical Technology","volume":"27 25","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ensuring safety and efficacy in combination products: regulatory challenges and best practices\",\"authors\":\"Deepak Kumar Gupta, Akhilesh Tiwari, Yashraj Yadav, Pranay Soni, Megha Joshi\",\"doi\":\"10.3389/fmedt.2024.1377443\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.\",\"PeriodicalId\":12599,\"journal\":{\"name\":\"Frontiers in Medical Technology\",\"volume\":\"27 25\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Frontiers in Medical Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3389/fmedt.2024.1377443\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in Medical Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3389/fmedt.2024.1377443","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

将药物、生物制剂和医疗器械融为一体的组合产品,以其创新疗法的潜力彻底改变了医疗保健领域。然而,这些产品中各种成分的交集带来了复杂的监管环境,需要严格关注安全性和有效性。本文深入探讨了与组合产品--药物、器械和生物制剂的交叉类别--相关的监管考虑因素、安全性和疗效评估的复杂情况。监管框架主要由美国食品和药物管理局(FDA)负责,需要对监管途径进行细致的分类。药物评价与研究中心 (CDER) 和器械与放射卫生中心 (CDRH) 等不同监管中心之间的合作强调了这些创新医疗解决方案所需的综合方法。安全性方面的考虑揭示了与不同成分组合相关的潜在风险和不良事件,强调了强有力的风险评估和缓解策略的必要性。疗效评估涉及复杂的方法学、临床试验和上市后监测,最近的进步还融入了数字技术。这一全面的探索旨在促进监管和科学领域不断发展的理解和最佳实践,促进组合产品开发和评估方面的合作与创新。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Ensuring safety and efficacy in combination products: regulatory challenges and best practices
Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Case Report: The effect of automated manual lymphatic drainage therapy on lymphatic contractility in 4 distinct cases Detection of natural autoimmunity to ghrelin in diabetes mellitus Ensuring safety and efficacy in combination products: regulatory challenges and best practices Augmented reality-based software (Echo-QR) for guiding the echographic probe toward the acoustic window: a pilot study Ethical considerations in the regulation and use of herbal medicines in the European Union
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1