PDF(Pubmed)
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.
摘要：
组合产品,合并药物，生物制剂,和医疗设备，以其创新疗法的潜力彻底改变了医疗保健领域。然而,这些产品中不同组件的交叉带来了复杂的监管环境，要求严格注意安全性和有效性。本文深入探讨了监管考虑因素的错综复杂的局面，安全,以及与组合产品相关的功效评估-药物交叉的类别，设备,和生物制品。监管框架，主要由美国食品和药物管理局（FDA）管理，需要细致入微的分类来确定调节途径。不同监管中心之间的合作，如药物评估和研究中心（CDER）和设备和放射健康中心（CDRH），强调了这些创新医疗解决方案所需的综合方法。安全考虑因素揭示了与组合不同组件相关的潜在风险和不良事件。强调需要强有力的风险评估和缓解战略。疗效评估涉及复杂的方法，临床试验,和上市后的监督，结合数字技术的最新进展。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，在组合产品的开发和评估中促进协作和创新。
