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Advertising广告
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Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements
直接面对消费者宣传标签和广告的量化信息呈现
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Updating Promotional Materials to Reflect Labeling Changes to Risk Information
更新宣传材料反映出风险信息的标签变化
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Clinical/Antimicrobial临床/抗菌
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Cytomegalovirus in Transplantation: Developing Drugs for Treatment and Prevention
移植中的巨细胞病毒：治疗和预防用药物的开发
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Smallpox (Variola Virus) Infection: Developing Drugs for Treatment and Prevention;Revised Draft
天花（天花病毒）感染：治疗和预防用药物的开发；修订草案
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Streamlining Pediatric HIV Antiretroviral Drug Development Intended for Global Use
用于全球精简儿童HIV抗逆转录病毒药物的开发
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Uncomplicated Urinary Tract Infections: Developing Antimicrobial Drugs for Treatment
非复杂性尿路感染：治疗用抗菌药物的开发
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Clinical/Medical临床/医学
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Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment
肌萎缩性侧索硬化症：治疗用药物的开发
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Antiepileptic Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adult to Pediatrics Patients 4 Years of Age and Older
治疗部分发作性癫痫的抗癫痫药物：对成人和4岁及以上儿科患者疗效的全面推断
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Early Alzheimer’s Disease: Developing Drugs for Treatment
早期阿尔茨海默氏病：治疗用药物的开发
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Hypertension: Developing Fixed-Dose Combination Drugs for Treatment
高血压：治疗用固定剂量联合用药的开发
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Migraine: Developing Drugs for Treatment
偏头痛：治疗用药物的开发
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Opioid Dependence: Developing Depot Buprenorphine Products for Treatment
阿片类药物依赖：治疗用丁丙诺啡产品的开发
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Pediatric Oncology Product Development; Revised Draft
儿科肿瘤学产品开发；修订草案
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Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
临床试验中的孕妇—科学和伦理考虑
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Pregnancy, Prevention and Planning: Recommendations for Pregnancy Testing and Contraception for Drugs with Teratogenic Potential
怀孕、预防和计划：对具有致畸潜能的药物进行妊娠试验和避孕的建议
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Clinical Pharmacology临床药理
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Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations
评估食物对研究用新药或新药申请中药品的影响—总则
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Bioavailability Studies Submitted in NDAs for INDs – General Considerations
新药申请中研究用新药生物利用度研究的提交–总则
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Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations, Revised Draft
临床药物相互作用研究：研究，设计，数据分析，给药和标签推荐的影响，修订草案
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General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
药物和生物制品新生儿研究的一般临床药理学考虑
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In Vitro Metabolism-and-Transporter -Mediated Drug-Drug Interaction Studies; Revised Draft
体外代谢与转运蛋白介导的药物相互作用研究；修订草案
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Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling; Revised Draft
肾功能损害患者的药代动力学-研究设计、数据分析及剂量和标签的影响；修订草案
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Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data Analysis and Impact on Dosing and Labeling
肝功能受损患者的药代动力学--研究设计、数据分析及剂量和标签的影响
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Pharmacogenomic Data Submission
药物基因组学数据提交
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Clinical/Statistical临床/统计
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Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft
药品和生物制品临床试验的适应性设计；修订草案
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Adjusting for Covariates in Randomized Experiments
随机实验中协变量的调整
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Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products
人用药品或生物制品安全性评估的随机对照试验的Meta分析
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Drug Development Tools新药研发工具
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Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and FDA Staff
生物标志物的确认：证据框架；对行业与FDA工作人员的指南草案
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Drug Safety药品安全
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Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft
人用药品、生物制品包括疫苗的上市后安全报告，修订草案
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Restricted Delivery Systems: Flow Restrictors and Oral Liquid Drug Products
限制给药系统：剂量受控以及口服液制剂
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Electronic Submissions电子申报
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Standardized Format for Electronic Submissions of NDA and BLA Content for the Planning and Conduct of Bioresearch Monitoring Inspections for CDER Submissions
NDA和BLA用于计划执行生物学研究监测检查的电子申报的标准化格式
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Providing Regulatory Submissions in Electronic Format – Drug
以电子格式规范提交—药品
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Establishment Registration and Drug Listing
建立登记和药品目录
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Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
以电子格式规范提交—生物分析方法数据标准
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Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data
以电子格式规范提交—标准化的生物分析数据
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Generics仿制药
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180-Day Exclusivity: Questions and Answers
180天市场独占期：问答
|
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Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches; Revised Draft
ANDAs 对透皮给药系统和外用贴剂粘附性的评价，修订草案
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Assessing Irritation and Sensitization Potentials of Generic Transdermal and Topical Patches Submitted in ANDAs
ANDAS中提交的一般经皮给药和外用贴剂的刺激和致敏电位评价
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs; Revised Draft
ANDA中药品具有药代动力学终点的生物等效性研究的提交；修订草案
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Failure to Timely Respond to an ANDA CR Letter
ANDA中受控通信（CR）的未及时回复
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Referencing Approved Drug Products in ANDA Submissions; Revised Draft
ANDA提交中的参比药品；修订草案
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Sameness Under the 505(j) Pathway
按照505(j)路径的一致性
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Therapeutic Equivalence – General Considerations
治疗等效性-总则
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Three-Year Exclusivity Determinations for Drug Products
药品三年独占期判定
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Variations in Drug Products (ANDAs) Guidance
ANDAs药品指南的变化
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Labeling标签
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Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
人用处方药品和生物制品标签，药品滥用和依赖部分—内容和格式
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Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
人用处方药和生物制品标签，适应症和使用部分—内容和格式
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Instructions for Use for Human Prescription Drug and Biological Products – Content and Format
人用处方药和生物制品的使用说明—内容和格式
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Labeling for Combined Hormonal Contraceptives
联合激素避孕药的标签
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Pregnancy, Lactation and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products; Revised Draft
人用处方药和生物制品标签，怀孕哺乳以及生殖潜能；修订草案
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Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
人用处方药和生物制品中产品名称以及最初美国批准的处方信息的警示语-内容和格式
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Recommended Statement for Over-the-Counter (OTC) Aspirin-Containing Drug
Products Labeled with Cardiovascular-Related Imagery Guidance for Industry
非处方药中标有心血管相关影像行业指南的含阿司匹林药品的推荐声明
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Over-The-Counter 非处方药OTC
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Innovative Approaches for Nonprescription Drug Products
非处方药的创新方法
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Maximal Usage Trial for Topical Active Ingredients Being Considered in the Over-the-Counter Monograph: Study Elements and Considerations
非处方专著中应考虑的外用活性成分的最大使用量试验：研究内容和考虑因素
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Pharmaceutical Quality/Microbiology药品质量/微生物学
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Microbiological Considerations for Non-Sterile Drug Products
非无菌药品微生物考虑点
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Pharmaceutical Quality/CMC药品质量/CMC
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CDER’s Program for the Recognition of Voluntary Consensus Standards
CDER承认自愿协商一致标准的程序
|
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Clarification of Human Drug Application Establishment Information Q&A Guidance
澄清人用药物申请场所信息问答的指南
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Drug Master Files; Revised Draft Version: 19 January 2018
DMF；修订草案2018年1月19日
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Harmonizing Compendial Standards with Drug Application CMC Approval
Requirements Using the USP Pending Monograph Process
协调药典标准与与药品申请CMC批准要求采用USP征求意见稿的流程
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Identification of Manufacturing Establishments in Applicants Submitted to CBER and CDER – Questions and Answers
提交给CBER和CDER的申请中生产场所的识别-问答
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In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
阿片类药物滥用抑制特性的体外评价方法
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Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry,Manufacturing, and Controls Documentation; Revised Draft
计量吸入器（MDI）和干粉吸入器（DPI）的药品-化学，制造和控制文件；修订草案
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Post-Approval Changes to Drug Substances (GDUFAII)
批准后的变更原料药(GDUFAII)
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Product Development and Quality Control of Transdermal and Related Delivery Systems
经皮给药及相关给药系统的产品开发和质量控制
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Quality Considerations for Continuous Manufacturing (CM)
连续生产(CM)的质量考虑点
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Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software
CDER管辖的利用电子或软件的设备部件组合产品的V类DMF
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Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments
使用液体和/或软性食品给药：产品质量评估的选择和体外方法的一般考虑
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Using the Inactive Ingredient Database
非活性成分数据库的使用
|
|
Pharmaceutical Quality/Manufacturing Standards (CGMP) 药品质量/制造标准（CGMP）
|
|
CGMP Final Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Revised Draft
根据FD&C法案503B部分人用药品配制外包设施的CGMP最终临时指南；修订草案
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Field Alert Report Submission
区域警示报告提交
|
|
Pharmacology/Toxicology药理/毒理学
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Nonclinical Safety Evaluation of Ophthalmic Pharmaceuticals
眼科药物非临床安全性评估
|
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Procedural程序
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Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
根据《联邦食品、药品和化妆品法》第505（q）条诉讼中止的公民请愿和诉讼
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Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements
未能满足加速上市后需求的民事罚款
|
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Content of Threshold Analyses and Human Factors Submissions to an NDA, BLA or ANDA
提交一份NDA, BLA 或ANDA的阈值分析和人为因素的内容
|
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Definitions of Suspect Product and Illegitimate Product or Verification Obligations
可疑产品和非法产品或核查义务的定义
|
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Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification
505(b)(2)或ANDA申请发送第IV部分专利认定通知的指定的运送服务
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Development of a Shared System REMS
共用系统缓解策略（REMS）的开发
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Good Review Management Principles and Practices for PDUFA and BsUFA Products
PDUFA 和 BsUFA产品的良好审评管理原则和实践
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Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
对无产品标识的产品包装和统一的过渡政策
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Implementation of the "Deemed to be a License" Provision of the BPCI Act: Questions and Answers
实施BPCI法案中"视为许可"的规定：问答
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Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft
根据儿科研究公平法案和最佳儿童药物法案进行儿科产品开发：科学考虑点；修订草案
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Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft
根据儿科研究公平法案和最佳儿童药物法案进行儿科产品开发：法规监管考虑点；修订草案
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Proposed Accreditation Program Under the Drug Supply Chain Security Act
Version: 19 January 2018
根据药品供应链安全法案拟定认证方案 版本：2018年1月19日
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Proposed Licensing Program Under the Drug Supply Chain Security Act
根据药品供应链安全法案撰写许可程序
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Public Disclosure of FDA-Sponsored Studies
FDA发起研究的公开披露
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Qualified Infectious Disease Product Designation: Questions and Answers
传染病产品认定的确认：问答
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REMS Assessment: Planning and Reporting
缓解策略（REMS）评估：计划和报告
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Standardization of Data and Documentation Practices for Product Tracing
产品跟踪的数据和文件操作的标准化
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Streamlined Submission Process to Determine Whether an Investigational In Vitro
精简提交程序以确定是否进行体外研究
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Companion Diagnostic in an Oncology Trial is Significant Risk
肿瘤学试验中进行同伴诊断颇具风险
|
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Survey Methodologies to Assess REMS Goals Related to Knowledge
评估缓解策略（REMS）目标关于知识方面的调查方法
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The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers
人用处方药成品：问答
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Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies(REMS)
共用系统风险评估和缓解策略（REMS）采用DMF
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Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
根据食品供应链安全法对某些处方药的核查系统
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Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act
联邦食品，药品和化妆品法案582部分要求的豁免和例外
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Waivers of the Single, Shared System REMS Requirement
单一，共用系统缓解策略（REMS）要求 的豁免
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Rare Diseases罕见病
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Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
罕见疾病：早期药物开发和前期会议的作用
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Rare Diseases: Common Issues in Drug Development
罕见病：药物开发中的常见问题
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User Fees用户付费
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Prescription Drug User Fee Act Waivers for Fixed Dose Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief
处方药用户付费法案中对抗艾滋用总统紧急救援计划中的固定剂量联合抗逆转录病毒药物的豁免
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Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products
处方药用户付费法案豁免，减少以及药品和生物制品退款
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ALL
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Pharma Sources Insight June 2024: Globalization on the Go
