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I. 引言 本指南旨在帮助申请人准备向 FDA 提交简化新药申请（ANDA）。本指南强调了可能导致 ANDA 批准延迟的常见和反复出现的缺陷。本指南还向申请人提出了如何避免这些缺陷的建议，以尽量减少批准所需的审查周期。本文件的内容不具有法律效力，也不以任何方式约束公众，除非明确纳入合同。本文件仅旨在向公众说明法律规定的现有要求。除非引用特定的监管或法定要求，否则 FDA 指南文件（包括本指南）应仅被视为建议。FDA 指南中的“应该”一词的意思是建议或推荐某事，但不要求这样做。II.背景 2012 年仿制药用户费用修正案 (GDUFA I) 2 于 2012 年 7 月 9 日签署成为法律。根据 FDA 和行业协商达成的协议 3，GDUFA I 旨在提高美国消费者及时获得低成本、安全、有效和高质量仿制药的可能性，并提高 ANDA 审查过程的可预测性。根据 GDUFA I，FDA 构建了一个现代化的仿制药计划，从而使 FDA 与行业、ANDA 监管行动和 ANDA 批准之间的沟通显著且持续增加。
指导草案
指导草案 本指导文件仅供评论之用。有关本草案的评论和建议应在《联邦公报》上公布指导草案发布通知后 60 天内提交。请将电子评论发送至 https://www.regulations.gov。请将书面评论发送至食品药品管理局卷宗管理人员（HFA-305），地址：5630 Fishers Lane, Rm. 1061, Rockville, MD 20852。所有评论均应注明在《联邦公报》上公布的发布通知中所列的卷宗编号。如对本草案有任何疑问，请联系 CDER 合规办公室，电话：301-796-3130 或电子邮箱：drugtrackandtrace@fda.hhs.gov；CDER 通讯办公室、药品信息部，电话：855-543-3784；或联系 CBER 沟通、推广和发展办公室，电话：800-835-4709 或 240-402-8010，邮箱：ocod@fda.hhs.gov。
指导 - msc-regulation-article-4-businesses.pdf
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指导材料
Trade Credit Arrangements ...............................................................................................................29 Disputed Payments ...........................................................................................................................31 Controlled Entity Data Not Accessible ..............................................................................................31 Payments made by a Third Party ......................................................................................................32 Preparing the TCP Dataset ................................................................................................................32 SBTCP Dataset ...................................................................................................................................37 Calculate Payment Times .....................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
麻疹指导
Final version : June 2024 Review Date : June 2026 Contributors: Rommel Ravanan: Consultant Nephrologist, North Bristol NHS Trust Chris Callaghan: Consultant Transplant Surgeon, Guy's and St Thomas' NHS Trust Jan Dudley: Consultant Paediatric Nephrologist, Bristol Royal Hospital For Children In response to the rising incidence of measles cases in more than one region in the UK, the UK Health Security机构（UKHSA）发布了国家麻疹指南（https://www.gov.uk/government/publications/template-template-template-template-to-paediatrician-oncologists-and-ancologists-and-and-soncologists-on-measless），包括对已经受到免疫抑制或可能是免疫抑制剂的专业人员的建议。高级UKHSA指南涵盖了广泛的护理原则，并且有望通过专业社会来解释这些原则，以为专业患者途径提供特定的操作指南。鉴于上述情况，英国移植协会在接收或在等待列表（WL）上接受的患者护理指南（SOT）如下。
软件验证的一般原则；行业和 FDA 工作人员的最终指南
SECTION 2.SCOPE 第 2 部分 范围 This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation system.For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law.本指导描述了医疗器械质量系统法规的某些条款如何应用到软件，以及 FDA 评价一个软件验证系统的 现行方法。例如，本文列出了 FDA 对于软件验证的可接受元素；但是，并未列出在一切情况下必须遵 循法律的所有活动和任务。 The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term.Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated.严格上讲，本指导的应用范围比验证的范围更广泛一些。计划、确认、测试、追溯性、配置管理及本 指导中讨论的良好软件工程的许多其他方面是重要的活动，它们有助于支持一个最终结论 - 软件是已验 证过的。 This guidance recommends an integration of software life cycle management and risk management activities.Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied.While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.本指导建议将软件生命周期管理和风险管理活动进行整合。根据预期用途和与开发的软件相关联的安 全风险，软件开发人员应确定特定方法，使用的多个技术的组合，以及应用尝试程度。虽然本指导未 推荐任何特定生命周期模式，或任何特定技术或方法，但建议整个软件生命周期需进行软件验证和确 认活动。 Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.若软件由某人而非器械生产商开发，如成品组件软件，这个软件开发者可能不直接负责 FDA 法规的符 合性。 In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.