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Advertising廣告
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Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements
直接面對(duì)消費(fèi)者宣傳標(biāo)簽和廣告的量化信息呈現(xiàn)
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Updating Promotional Materials to Reflect Labeling Changes to Risk Information
更新宣傳材料反映出風(fēng)險(xiǎn)信息的標(biāo)簽變化
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Clinical/Antimicrobial臨床/抗菌
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Cytomegalovirus in Transplantation: Developing Drugs for Treatment and Prevention
移植中的巨細(xì)胞病毒：治療和預(yù)防用藥物的開發(fā)
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Smallpox (Variola Virus) Infection: Developing Drugs for Treatment and Prevention;Revised Draft
天花（天花病毒）感染：治療和預(yù)防用藥物的開發(fā)；修訂草案
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Streamlining Pediatric HIV Antiretroviral Drug Development Intended for Global Use
用于全球精簡(jiǎn)兒童HIV抗逆轉(zhuǎn)錄病毒藥物的開發(fā)
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Uncomplicated Urinary Tract Infections: Developing Antimicrobial Drugs for Treatment
非復(fù)雜性尿路感染：治療用抗菌藥物的開發(fā)
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Clinical/Medical臨床/醫(yī)學(xué)
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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)
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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
治療部分發(fā)作性癲癇的抗癲癇藥物：對(duì)成人和4歲及以上兒科患者療效的全面推斷
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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)
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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)
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Migraine: Developing Drugs for Treatment
偏頭痛：治療用藥物的開發(fā)
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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)
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Pediatric Oncology Product Development; Revised Draft
兒科腫瘤學(xué)產(chǎn)品開發(fā)；修訂草案
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Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
臨床試驗(yàn)中的孕婦—科學(xué)和倫理考慮
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Pregnancy, Prevention and Planning: Recommendations for Pregnancy Testing and Contraception for Drugs with Teratogenic Potential
懷孕、預(yù)防和計(jì)劃：對(duì)具有致畸潛能的藥物進(jìn)行妊娠試驗(yàn)和避孕的建議
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Clinical Pharmacology臨床藥理
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Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations
評(píng)估食物對(duì)研究用新藥或新藥申請(qǐng)中藥品的影響—總則
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Bioavailability Studies Submitted in NDAs for INDs – General Considerations
新藥申請(qǐng)中研究用新藥生物利用度研究的提交–總則
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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(shè)計(jì)，數(shù)據(jù)分析，給藥和標(biāo)簽推薦的影響，修訂草案
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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(xué)考慮
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In Vitro Metabolism-and-Transporter -Mediated Drug-Drug Interaction Studies; Revised Draft
體外代謝與轉(zhuǎn)運(yùn)蛋白介導(dǎo)的藥物相互作用研究；修訂草案
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Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling; Revised Draft
腎功能損害患者的藥代動(dòng)力學(xué)-研究設(shè)計(jì)、數(shù)據(jù)分析及劑量和標(biāo)簽的影響；修訂草案
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Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data Analysis and Impact on Dosing and Labeling
肝功能受損患者的藥代動(dòng)力學(xué)--研究設(shè)計(jì)、數(shù)據(jù)分析及劑量和標(biāo)簽的影響
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Pharmacogenomic Data Submission
藥物基因組學(xué)數(shù)據(jù)提交
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Clinical/Statistical臨床/統(tǒng)計(jì)
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Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft
藥品和生物制品臨床試驗(yàn)的適應(yīng)性設(shè)計(jì)；修訂草案
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Adjusting for Covariates in Randomized Experiments
隨機(jī)實(shí)驗(yàn)中協(xié)變量的調(diào)整
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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(píng)估的隨機(jī)對(duì)照試驗(yàn)的Meta分析
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Drug Development Tools新藥研發(fā)工具
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Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and FDA Staff
生物標(biāo)志物的確認(rèn)：證據(jù)框架；對(duì)行業(yè)與FDA工作人員的指南草案
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Drug Safety藥品安全
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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(bào)告，修訂草案
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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
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Electronic Submissions電子申報(bào)
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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用于計(jì)劃執(zhí)行生物學(xué)研究監(jiān)測(cè)檢查的電子申報(bào)的標(biāo)準(zhǔn)化格式
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Providing Regulatory Submissions in Electronic Format – Drug
以電子格式規(guī)范提交—藥品
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Establishment Registration and Drug Listing
建立登記和藥品目錄
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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(biāo)準(zhǔn)
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Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data
以電子格式規(guī)范提交—標(biāo)準(zhǔn)化的生物分析數(shù)據(jù)
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Generics仿制藥
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180-Day Exclusivity: Questions and Answers
180天市場(chǎng)獨(dú)占期：?jiǎn)柎?/p>
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Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches; Revised Draft
ANDAs 對(duì)透皮給藥系統(tǒng)和外用貼劑粘附性的評(píng)價(jià)，修訂草案
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Assessing Irritation and Sensitization Potentials of Generic Transdermal and Topical Patches Submitted in ANDAs
ANDAS中提交的一般經(jīng)皮給藥和外用貼劑的刺激和致敏電位評(píng)價(jià)
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs; Revised Draft
ANDA中藥品具有藥代動(dòng)力學(xué)終點(diǎn)的生物等效性研究的提交；修訂草案
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Failure to Timely Respond to an ANDA CR Letter
ANDA中受控通信（CR）的未及時(shí)回復(fù)
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Referencing Approved Drug Products in ANDA Submissions; Revised Draft
ANDA提交中的參比藥品；修訂草案
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Sameness Under the 505(j) Pathway
按照505(j)路徑的一致性
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Therapeutic Equivalence – General Considerations
治療等效性-總則
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Three-Year Exclusivity Determinations for Drug Products
藥品三年獨(dú)占期判定
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Variations in Drug Products (ANDAs) Guidance
ANDAs藥品指南的變化
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Labeling標(biāo)簽
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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(biāo)簽，藥品濫用和依賴部分—內(nèi)容和格式
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Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
人用處方藥和生物制品標(biāo)簽，適應(yīng)癥和使用部分—內(nèi)容和格式
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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
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Labeling for Combined Hormonal Contraceptives
聯(lián)合激素避孕藥的標(biāo)簽
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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(biāo)簽，懷孕哺乳以及生殖潛能；修訂草案
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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
人用處方藥和生物制品中產(chǎn)品名稱以及最初美國(guó)批準(zhǔn)的處方信息的警示語-內(nèi)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
非處方藥中標(biāo)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
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Over-The-Counter 非處方藥OTC
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Innovative Approaches for Nonprescription Drug Products
非處方藥的創(chuàng)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
非處方專著中應(yīng)考慮的外用活性成分的最大使用量試驗(yàn)：研究?jī)?nèi)容和考慮因素
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Pharmaceutical Quality/Microbiology藥品質(zhì)量/微生物學(xué)
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Microbiological Considerations for Non-Sterile Drug Products
非無菌藥品微生物考慮點(diǎn)
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Pharmaceutical Quality/CMC藥品質(zhì)量/CMC
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CDER’s Program for the Recognition of Voluntary Consensus Standards
CDER承認(rèn)自愿協(xié)商一致標(biāo)準(zhǔn)的程序
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Clarification of Human Drug Application Establishment Information Q&A Guidance
澄清人用藥物申請(qǐng)場(chǎng)所信息問答的指南
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Drug Master Files; Revised Draft Version: 19 January 2018
DMF；修訂草案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
協(xié)調(diào)藥典標(biāo)準(zhǔn)與與藥品申請(qǐng)CMC批準(zhǔn)要求采用USP征求意見稿的流程
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Identification of Manufacturing Establishments in Applicants Submitted to CBER and CDER – Questions and Answers
提交給CBER和CDER的申請(qǐng)中生產(chǎn)場(chǎng)所的識(shí)別-問答
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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(píng)價(jià)方法
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Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry,Manufacturing, and Controls Documentation; Revised Draft
計(jì)量吸入器（MDI）和干粉吸入器（DPI）的藥品-化學(xué)，制造和控制文件；修訂草案
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Post-Approval Changes to Drug Substances (GDUFAII)
批準(zhǔn)后的變更原料藥(GDUFAII)
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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
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Quality Considerations for Continuous Manufacturing (CM)
連續(xù)生產(chǎn)(CM)的質(zhì)量考慮點(diǎn)
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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管轄的利用電子或軟件的設(shè)備部件組合產(chǎn)品的V類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
使用液體和/或軟性食品給藥：產(chǎn)品質(zhì)量評(píng)估的選擇和體外方法的一般考慮
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Using the Inactive Ingredient Database
非活性成分?jǐn)?shù)據(jù)庫的使用
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Pharmaceutical Quality/Manufacturing Standards (CGMP) 藥品質(zhì)量/制造標(biāo)準(zhǔn)（CGMP）
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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(shè)施的CGMP最終臨時(shí)指南；修訂草案
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Field Alert Report Submission
區(qū)域警示報(bào)告提交
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Pharmacology/Toxicology藥理/毒理學(xué)
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Nonclinical Safety Evaluation of Ophthalmic Pharmaceuticals
眼科藥物非臨床安全性評(píng)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(qǐng)?jiān)负驮V訟
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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
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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的閾值分析和人為因素的內(nèi)容
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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(wù)的定義
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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申請(qǐng)發(fā)送第IV部分專利認(rèn)定通知的指定的運(yùn)送服務(wù)
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Development of a Shared System REMS
共用系統(tǒng)緩解策略（REMS）的開發(fā)
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Good Review Management Principles and Practices for PDUFA and BsUFA Products
PDUFA 和 BsUFA產(chǎn)品的良好審評(píng)管理原則和實(shí)踐
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Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
對(duì)無產(chǎn)品標(biāo)識(shí)的產(chǎn)品包裝和統(tǒng)一的過渡政策
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Implementation of the "Deemed to be a License" Provision of the BPCI Act: Questions and Answers
實(shí)施BPCI法案中"視為許可"的規(guī)定：?jiǎn)柎?/p>
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Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft
根據(jù)兒科研究公平法案和最佳兒童藥物法案進(jìn)行兒科產(chǎn)品開發(fā)：科學(xué)考慮點(diǎn)；修訂草案
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Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft
根據(jù)兒科研究公平法案和最佳兒童藥物法案進(jìn)行兒科產(chǎn)品開發(fā)：法規(guī)監(jiān)管考慮點(diǎn)；修訂草案
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Proposed Accreditation Program Under the Drug Supply Chain Security Act
Version: 19 January 2018
根據(jù)藥品供應(yīng)鏈安全法案擬定認(rèn)證方案 版本：2018年1月19日
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Proposed Licensing Program Under the Drug Supply Chain Security Act
根據(jù)藥品供應(yīng)鏈安全法案撰寫許可程序
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Public Disclosure of FDA-Sponsored Studies
FDA發(fā)起研究的公開披露
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Qualified Infectious Disease Product Designation: Questions and Answers
傳染病產(chǎn)品認(rèn)定的確認(rèn)：?jiǎn)柎?/p>
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REMS Assessment: Planning and Reporting
緩解策略（REMS）評(píng)估：計(jì)劃和報(bào)告
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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(biāo)準(zhǔn)化
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Streamlined Submission Process to Determine Whether an Investigational In Vitro
精簡(jiǎn)提交程序以確定是否進(jìn)行體外研究
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Companion Diagnostic in an Oncology Trial is Significant Risk
腫瘤學(xué)試驗(yàn)中進(jìn)行同伴診斷頗具風(fēng)險(xiǎn)
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Survey Methodologies to Assess REMS Goals Related to Knowledge
評(píng)估緩解策略（REMS）目標(biāo)關(guān)于知識(shí)方面的調(diào)查方法
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The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers
人用處方藥成品：?jiǎn)柎?/p>
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Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies(REMS)
共用系統(tǒng)風(fēng)險(xiǎn)評(píng)估和緩解策略（REMS）采用DMF
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Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
根據(jù)食品供應(yīng)鏈安全法對(duì)某些處方藥的核查系統(tǒng)
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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
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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
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Rare Diseases罕見病
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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(huì)議的作用
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Rare Diseases: Common Issues in Drug Development
罕見病：藥物開發(fā)中的常見問題
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User Fees用戶付費(fèi)
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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
處方藥用戶付費(fèi)法案中對(duì)抗艾滋用總統(tǒng)緊急救援計(jì)劃中的固定劑量聯(lián)合抗逆轉(zhuǎn)錄病毒藥物的豁免
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Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products
處方藥用戶付費(fèi)法案豁免，減少以及藥品和生物制品退款
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