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摩熵说直播
最新改良型新药及创新药立项开发
- GLP-1
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions
2024-06-05
FDA-2024-D-2221
指导原则
美国
现行有效
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美国食品药品监督管理局(FDA)
最新政策法规资讯
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政策法规解析 创新药临床审批 政策变动 采集意见
药通社2025-06-17
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医药器械 政策解析 采集 市场分析
摩熵医械2025-06-03
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政策解析 宠物医疗 驱虫药
药融圈2025-05-29
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医保局 政策法规 三类医用耗材 采购新规
摩熵器械2025-05-28
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FDA 临床试验 CGT 药物审评审批 法案
生物药大时代2025-05-19
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国家药品集采 政策 药企 药品信息变更
药通社2025-02-20
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医用耗材 医用耗材集采 集采新规
tyc7111cc太阳成集团2025-01-08
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医保 医疗保障工作 医保改革
tyc7111cc太阳成集团2024-12-17
最新指导原则
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关于征集<中心静脉导管产品注册技术审查指导原则(2025年修订版)>修订工作参与企业及单位信息的通知
2025-05-30
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市场监管总局关于发布<特定全营养配方食品临床试验技术指导原则 肝病>等文件的公告
2025-05-26
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国家药监局药审中心关于发布<阿尔茨海默病药物临床试验技术指导原则(试行)>的通告(2025年第19号)
2025-05-22
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zonisamide(唑尼沙胺-be指导原则)
2025-05-20
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migalastat hydrochloride(盐酸米加司他-be指导原则)
2025-05-20
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ceftobiprole medocaril sodium(头孢比罗酯钠-be指导原则)
2025-05-20
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daridorexant(奈莫雷生-be指导原则)
2025-05-20
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epinephrine(肾上腺素-be指导原则)
2025-05-20
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metformin hydrochloride(盐酸二甲双胍-be指导原则)
2025-05-20
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zilucoplan sodium
2025-05-20
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deutetrabenazine(氘丁苯那嗪-be指导原则)
2025-05-20
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terbinafine(特比萘芬-be指导原则)
2025-05-20
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etrasimod arginine(依曲莫德-be指导原则)
2025-05-20
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国家药监局器审中心关于发布移动医疗器械注册审查指导原则(2025年修订版)的通告(2025年第9号)
2025-05-07
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关于发布2025年度医疗器械注册审查指导原则编制计划的通告(2025年第10号)
2025-05-07
同部门最新指导原则
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Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
2024-11-15
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Guidance for Industry: FDA's Voluntary Qualified Importer Program
2024-11-14
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CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24)
2024-11-01
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Study Data Technical Conformance Guide - Technical Specifications Document
2024-10-31
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M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
2024-10-30
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CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients
2024-10-24
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Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination
2024-10-22
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Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
2024-10-21
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Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
2024-10-17
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Postoperative Nausea and Vomiting: Developing Drugs for Prevention
2024-10-17
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Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method
2024-10-17
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Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for Industry
2024-10-17
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Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry
2024-10-17
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Requests for Reconsideration at the Division Level Under GDUFA
2024-10-16
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CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food
2024-10-15
同地域最新指导原则
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institutional review board (irb) written procedures: guidance for institutions and irbs(机构审查委员会(irb)书面程序:机构及irb指南)
2025-02-05
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recommendations to reduce the risk of transmission of mycobacterium tuberculosis (mtb) by human cells, tissues, and cellular and tissue-based products (hct/ps): guidance for industry(减少人体细胞、组织及细胞和组织产品(hct/ps)传播结核分枝杆菌(mtb)风险的推荐:行业指南)
2025-01-31
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recommendations to reduce the risk of transmission of disease agents associated with sepsis by human cells, tissues, and cellular and tissue-based products (hct/ps): guidance for industry(减少人类细胞、组织及细胞和组织产品(hct/ps)传播与败血症相关疾病因子风险的建议:行业指南)
2025-01-31
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developing drugs for optical imaging(开发用于光学成像的药物)
2025-01-07
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artificial intelligence-enabled device software functions: lifecycle management and marketing submission recommendations: draft guidance for industry and food and drug administration staff(人工智能赋能设备软件功能:生命周期管理与市场提交建议:行业和食品药品监督管理局工作人员指南草案)
2025-01-07
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cvm gfi #294 - animal food ingredient consultation (afic)(cvm gfi #294 -动物食品成分咨询(afic))
2025-01-07
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notifying fda of a permanent discontinuance or interruption in manufacturing of a device under section 506j of the fd&c act: guidance for industry and food and drug administration staff(根据<联邦食品、药品和化妆品法案>(fd&c act)第506j条通知 fda 永久停止或中断设备制造:行业和食品药品监督管理局工作人员指南)
2025-01-07
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accelerated approval and considerations for determining whether a confirmatory trial is underway(加速批准和确定确认性试验是否正在进行的考虑因素)
2025-01-07
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cvm gfi #260 - type vii veterinary master file for research and development and risk reviews(cvm gfi #260 - vii型兽医主文件用于研发和风险评估)
2025-01-07
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considerations for the use of artificial intelligence to support regulatory decision-making for drug and biological products: draft guidance for industry and other interested parties(使用人工智能支持药品和生物制品监管决策的考虑因素:行业及其他利益相关方指南草案)
2025-01-07
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obesity and overweight: developing drugs and biological products for weight reduction(肥胖和超重:开发用于减重的药物和生物制品)
2025-01-07
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cvm gfi #251 - heritable intentional genomic alterations in animals of food-producing species for use as models of disease(cvm gfi #251 - 用于疾病模型的食用动物物种中可遗传的有意基因组改变)
2025-01-07
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pulse oximeters for medical purposes - non-clinical and clinical performance testing, labeling, and premarket submission recommendations: draft guidance for industry and food and drug administration staff(医疗用脉搏血氧仪-非临床和临床性能测试、标签以及上市前提交建议:行业和食品药品监督管理局工作人员指南草案)
2025-01-07
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cvm gfi #187b heritable intentional genomic alterations in animals: the approval process(cvm gfi #187b 动物可遗传有意基因组改变:审批过程)
2025-01-07
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evaluation of sex-specific and gender-specific data in medical device clinical studies: draft guidance for industry and food and drug administration staff(医疗器械临床试验中性别特异性和性别差异数据评估:行业和食品药品监督管理局工作人员指南草案)
2025-01-07
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