Advertising廣告

Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements

直接面對消費者宣傳標簽和廣告的量化信息呈現(xiàn)

Updating Promotional Materials to Reflect Labeling Changes to Risk Information

更新宣傳材料反映出風險信息的標簽變化

Clinical/Antimicrobial臨床/抗菌

Cytomegalovirus in Transplantation: Developing Drugs for Treatment and Prevention

移植中的巨細胞病毒：治療和預防用藥物的開發(fā)

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment and Prevention;Revised Draft

天花（天花病毒）感染：治療和預防用藥物的開發(fā)；修訂草案

Streamlining Pediatric HIV Antiretroviral Drug Development Intended for Global Use

用于全球精簡兒童HIV抗逆轉(zhuǎn)錄病毒藥物的開發(fā)

Uncomplicated Urinary Tract Infections: Developing Antimicrobial Drugs for Treatment

非復雜性尿路感染：治療用抗菌藥物的開發(fā)

Clinical/Medical臨床/醫(yī)學

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment

肌萎縮性側(cè)索硬化癥：治療用藥物的開發(fā)

Antiepileptic Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adult to Pediatrics Patients 4 Years of Age and Older

治療部分發(fā)作性癲癇的抗癲癇藥物：對成人和4歲及以上兒科患者療效的全面推斷

Early Alzheimer’s Disease: Developing Drugs for Treatment

早期阿爾茨海默氏?。褐委熡盟幬锏拈_發(fā)

Hypertension: Developing Fixed-Dose Combination Drugs for Treatment

高血壓：治療用固定劑量聯(lián)合用藥的開發(fā)

Migraine: Developing Drugs for Treatment

偏頭痛：治療用藥物的開發(fā)

Opioid Dependence: Developing Depot Buprenorphine Products for Treatment

阿片類藥物依賴：治療用丁丙諾啡產(chǎn)品的開發(fā)

Pediatric Oncology Product Development; Revised Draft

兒科腫瘤學產(chǎn)品開發(fā)；修訂草案

Pregnant Women in Clinical Trials – Scientific and Ethical Considerations

臨床試驗中的孕婦—科學和倫理考慮

Pregnancy, Prevention and Planning: Recommendations for Pregnancy Testing and Contraception for Drugs with Teratogenic Potential

懷孕、預防和計劃：對具有致畸潛能的藥物進行妊娠試驗和避孕的建議

Clinical Pharmacology臨床藥理

Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations

評估食物對研究用新藥或新藥申請中藥品的影響—總則

 Bioavailability Studies Submitted in NDAs for INDs – General Considerations

新藥申請中研究用新藥生物利用度研究的提交–總則

Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations, Revised Draft

臨床藥物相互作用研究：研究，設計，數(shù)據(jù)分析，給藥和標簽推薦的影響，修訂草案

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

藥物和生物制品新生兒研究的一般臨床藥理學考慮

In Vitro Metabolism-and-Transporter -Mediated Drug-Drug Interaction Studies; Revised Draft

體外代謝與轉(zhuǎn)運蛋白介導的藥物相互作用研究；修訂草案

Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling; Revised Draft

腎功能損害患者的藥代動力學-研究設計、數(shù)據(jù)分析及劑量和標簽的影響；修訂草案

Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data Analysis and Impact on Dosing and Labeling

肝功能受損患者的藥代動力學--研究設計、數(shù)據(jù)分析及劑量和標簽的影響

Pharmacogenomic Data Submission

藥物基因組學數(shù)據(jù)提交

Clinical/Statistical臨床/統(tǒng)計

Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft

藥品和生物制品臨床試驗的適應性設計；修訂草案

Adjusting for Covariates in Randomized Experiments

隨機實驗中協(xié)變量的調(diào)整

Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

人用藥品或生物制品安全性評估的隨機對照試驗的Meta分析

Drug Development Tools新藥研發(fā)工具

Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and FDA Staff

生物標志物的確認：證據(jù)框架；對行業(yè)與FDA工作人員的指南草案

Drug Safety藥品安全

Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft

人用藥品、生物制品包括疫苗的上市后安全報告，修訂草案

Restricted Delivery Systems: Flow Restrictors and Oral Liquid Drug Products

限制給藥系統(tǒng)：劑量受控以及口服液制劑

Electronic Submissions電子申報

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用于計劃執(zhí)行生物學研究監(jiān)測檢查的電子申報的標準化格式

Providing Regulatory Submissions in Electronic Format – Drug

以電子格式規(guī)范提交—藥品

Establishment Registration and Drug Listing

建立登記和藥品目錄

Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards

以電子格式規(guī)范提交—生物分析方法數(shù)據(jù)標準

Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data

以電子格式規(guī)范提交—標準化的生物分析數(shù)據(jù)

Generics仿制藥

180-Day Exclusivity: Questions and Answers

180天市場獨占期：問答

Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches; Revised Draft

ANDAs 對透皮給藥系統(tǒng)和外用貼劑粘附性的評價，修訂草案

Assessing Irritation and Sensitization Potentials of Generic Transdermal and Topical Patches Submitted in ANDAs

ANDAS中提交的一般經(jīng)皮給藥和外用貼劑的刺激和致敏電位評價

Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs; Revised Draft

ANDA中藥品具有藥代動力學終點的生物等效性研究的提交；修訂草案

Failure to Timely Respond to an ANDA CR Letter

ANDA中受控通信（CR）的未及時回復

Referencing Approved Drug Products in ANDA Submissions; Revised Draft

ANDA提交中的參比藥品；修訂草案

Sameness Under the 505(j) Pathway

按照505(j)路徑的一致性

Therapeutic Equivalence – General Considerations

治療等效性-總則

Three-Year Exclusivity Determinations for Drug Products

藥品三年獨占期判定

Variations in Drug Products (ANDAs) Guidance

ANDAs藥品指南的變化

Labeling標簽

Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

人用處方藥品和生物制品標簽，藥品濫用和依賴部分—內(nèi)容和格式

Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format

人用處方藥和生物制品標簽，適應癥和使用部分—內(nèi)容和格式

Instructions for Use for Human Prescription Drug and Biological Products – Content and Format

人用處方藥和生物制品的使用說明—內(nèi)容和格式

Labeling for Combined Hormonal Contraceptives

聯(lián)合激素避孕藥的標簽

Pregnancy, Lactation and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products; Revised Draft

人用處方藥和生物制品標簽，懷孕哺乳以及生殖潛能；修訂草案

Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format

人用處方藥和生物制品中產(chǎn)品名稱以及最初美國批準的處方信息的警示語-內(nèi)容和格式

Recommended Statement for Over-the-Counter (OTC) Aspirin-Containing Drug

Products Labeled with Cardiovascular-Related Imagery Guidance for Industry

非處方藥中標有心血管相關(guān)影像行業(yè)指南的含阿司匹林藥品的推薦聲明

Over-The-Counter 非處方藥OTC

Innovative Approaches for Nonprescription Drug Products

非處方藥的創(chuàng)新方法

Maximal Usage Trial for Topical Active Ingredients Being Considered in the Over-the-Counter Monograph: Study Elements and Considerations

非處方專著中應考慮的外用活性成分的最大使用量試驗：研究內(nèi)容和考慮因素

Pharmaceutical Quality/Microbiology藥品質(zhì)量/微生物學

Microbiological Considerations for Non-Sterile Drug Products

非無菌藥品微生物考慮點

Pharmaceutical Quality/CMC藥品質(zhì)量/CMC

CDER’s Program for the Recognition of Voluntary Consensus Standards

CDER承認自愿協(xié)商一致標準的程序

Clarification of Human Drug Application Establishment Information Q&A Guidance

澄清人用藥物申請場所信息問答的指南

Drug Master Files; Revised Draft Version: 19 January 2018

DMF；修訂草案2018年1月19日

Harmonizing Compendial Standards with Drug Application CMC Approval

Requirements Using the USP Pending Monograph Process

協(xié)調(diào)藥典標準與與藥品申請CMC批準要求采用USP征求意見稿的流程

Identification of Manufacturing Establishments in Applicants Submitted to CBER and CDER – Questions and Answers

提交給CBER和CDER的申請中生產(chǎn)場所的識別-問答

In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products

阿片類藥物濫用抑制特性的體外評價方法

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry,Manufacturing, and Controls Documentation; Revised Draft

計量吸入器（MDI）和干粉吸入器（DPI）的藥品-化學，制造和控制文件；修訂草案

Post-Approval Changes to Drug Substances (GDUFAII)

批準后的變更原料藥(GDUFAII)

Product Development and Quality Control of Transdermal and Related Delivery Systems

經(jīng)皮給藥及相關(guān)給藥系統(tǒng)的產(chǎn)品開發(fā)和質(zhì)量控制

Quality Considerations for Continuous Manufacturing (CM)

連續(xù)生產(chǎn)(CM)的質(zhì)量考慮點

Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software

CDER管轄的利用電子或軟件的設備部件組合產(chǎn)品的V類DMF

Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

使用液體和/或軟性食品給藥：產(chǎn)品質(zhì)量評估的選擇和體外方法的一般考慮

Using the Inactive Ingredient Database

非活性成分數(shù)據(jù)庫的使用

Pharmaceutical Quality/Manufacturing Standards (CGMP) 藥品質(zhì)量/制造標準（CGMP）

CGMP Final Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Revised Draft

根據(jù)FD&C法案503B部分人用藥品配制外包設施的CGMP最終臨時指南；修訂草案

Field Alert Report Submission

區(qū)域警示報告提交

Pharmacology/Toxicology藥理/毒理學

Nonclinical Safety Evaluation of Ophthalmic Pharmaceuticals

眼科藥物非臨床安全性評估

Procedural程序

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

根據(jù)《聯(lián)邦食品、藥品和化妝品法》第505（q）條訴訟中止的公民請愿和訴訟

Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements

未能滿足加速上市后需求的民事罰款

Content of Threshold Analyses and Human Factors Submissions to an NDA, BLA or ANDA

提交一份NDA, BLA 或ANDA的閾值分析和人為因素的內(nèi)容

Definitions of Suspect Product and Illegitimate Product or Verification Obligations

可疑產(chǎn)品和非法產(chǎn)品或核查義務的定義

Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification

505(b)(2)或ANDA申請發(fā)送第IV部分專利認定通知的指定的運送服務

Development of a Shared System REMS

共用系統(tǒng)緩解策略（REMS）的開發(fā)

Good Review Management Principles and Practices for PDUFA and BsUFA Products

PDUFA 和 BsUFA產(chǎn)品的良好審評管理原則和實踐

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

對無產(chǎn)品標識的產(chǎn)品包裝和統(tǒng)一的過渡政策

Implementation of the "Deemed to be a License" Provision of the BPCI Act: Questions and Answers

實施BPCI法案中"視為許可"的規(guī)定：問答

Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft

根據(jù)兒科研究公平法案和最佳兒童藥物法案進行兒科產(chǎn)品開發(fā)：科學考慮點；修訂草案

Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft

根據(jù)兒科研究公平法案和最佳兒童藥物法案進行兒科產(chǎn)品開發(fā)：法規(guī)監(jiān)管考慮點；修訂草案

Proposed Accreditation Program Under the Drug Supply Chain Security Act

Version: 19 January 2018

根據(jù)藥品供應鏈安全法案擬定認證方案 版本：2018年1月19日

Proposed Licensing Program Under the Drug Supply Chain Security Act

根據(jù)藥品供應鏈安全法案撰寫許可程序

Public Disclosure of FDA-Sponsored Studies

FDA發(fā)起研究的公開披露

Qualified Infectious Disease Product Designation: Questions and Answers

傳染病產(chǎn)品認定的確認：問答

REMS Assessment: Planning and Reporting

緩解策略（REMS）評估：計劃和報告

Standardization of Data and Documentation Practices for Product Tracing

產(chǎn)品跟蹤的數(shù)據(jù)和文件操作的標準化

Streamlined Submission Process to Determine Whether an Investigational In Vitro

精簡提交程序以確定是否進行體外研究

Companion Diagnostic in an Oncology Trial is Significant Risk

腫瘤學試驗中進行同伴診斷頗具風險

Survey Methodologies to Assess REMS Goals Related to Knowledge

評估緩解策略（REMS）目標關(guān)于知識方面的調(diào)查方法

The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers

人用處方藥成品：問答

Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies(REMS)

共用系統(tǒng)風險評估和緩解策略（REMS）采用DMF

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

根據(jù)食品供應鏈安全法對某些處方藥的核查系統(tǒng)

Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act

聯(lián)邦食品，藥品和化妝品法案582部分要求的豁免和例外

Waivers of the Single, Shared System REMS Requirement

單一，共用系統(tǒng)緩解策略（REMS）要求 的豁免

Rare Diseases罕見病

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

罕見疾?。涸缙谒幬镩_發(fā)和前期會議的作用

Rare Diseases: Common Issues in Drug Development

罕見病：藥物開發(fā)中的常見問題

User Fees用戶付費

Prescription Drug User Fee Act Waivers for Fixed Dose Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief

處方藥用戶付費法案中對抗艾滋用總統(tǒng)緊急救援計劃中的固定劑量聯(lián)合抗逆轉(zhuǎn)錄病毒藥物的豁免

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products

處方藥用戶付費法案豁免，減少以及藥品和生物制品退款

New EU Guidelines新歐盟指南

GMP Guide: Annex 21 (Importation of medicinal products)

GMP指南：附錄21（藥品進口）

GMP and Marketing Authorisation Holders

GMP和上市許可持有人

Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container, EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V)

對藥品、活性物質(zhì)、輔料以及主要容器滅菌的指南EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V)

EU Guidelines under revision歐盟修訂指南

GMP Guide: Introductions

GMP指南：簡介

GMP Guide: Chapter 1 (Pharmaceutical Quality System)

GMP指南：第一章（制工經(jīng)質(zhì)量體系）

GMP Guide: Chapter 4 (Documentation)

GMP指南：第四章（文件）

GMP Guide: Annex 1 (Manufacture of Sterile Medicinal Products)

GMP指南：附錄1（無菌藥品的制造）

GMP Guide: Annex 11 (Computerised Systems)

GMP指南：附錄11（計算機化系統(tǒng)）

Guideline on the manufacture of the finished dosage form (V)

成品生產(chǎn)的指南(V)

Guideline on quality of water for pharmaceutical use (H+V)

制藥用水質(zhì)量指南(H+V)

ICH Guidelines ICH指南

ICH Q12 (Lifecycle Management)

ICH Q12生命周期管理

Other guidance其它指南

Q&As on the implementation of the updated shared facilities guidance

關(guān)于更新共用設施指南實施的問答