FDA更新汇总

REMS Integration Initiative

风险评估与减轻策略（REMS）法案整合

2017.12.04

CDER SBIA线上会议：REMS法案整合回顾（演讲和及其PPT已更新）

https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm

CDER Office of Surveillance and Epidemiology: 2017 Update

CDER监管和传染病办公室：2017年更新

2017.12.05

报告主要涉及不良反应，药物警戒，风险评估和缓和政策，处方鸦片滥用等方面。

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM587649.pdf

CDER New Drugs Program: 2017 Update

CDER新药计划：2017年更新

2017.12.05

主要涉及药品批准耗时方面的统计报告。

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM587690.pdf

Center for Drug Evaluation and Research- Compliance Central with FDA Center Compliance Directors: Part 1 Presentation

药品评估和调查中心——合规性中心和FDA合规性中心领导人员：演说，部分1

2017.12.06

CDER office of compliance overview.

CDER办公室合规性活动概述。

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM587828.pdf

Pediatric Rare Diseases — A Collaborative Approach for Drug Development Using Gaucher Disease as a Model

儿科罕见病——以高雪氏症为例，阐述药品研发的合作方法

Guidance for Industry

行业指南

2017.12.06

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM587660.pdf

Over-the-Counter Monograph User Fees – Stakeholder Webinar

OTC收费法案——股东网络研讨会

2017.12.07

更新股东对现状的了解，概述OTC收费法案涵盖的被提议的业绩目标和规程。

https://www.fda.gov/downloads/ForIndustry/UserFees/OTCMonographUserFee/UCM588040.pdf

Postmarketing Requirements and Commitments: Reports

上市后要求和承诺：报告（更新）

2017.12.08

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm

Prescription Drug User Fee Act

PDUFA

2017.12.11

https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm2005475.htm

CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals

CDER研究员对3D打印药物的前景和潜能的探索

2017.12.11

https://www.fda.gov/Drugs/NewsEvents/ucm588136.htm

Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements

产品名的放置，大小，以及广告标签和广告的突起

Guidance for Industry

行业指南

Advertising

广告

2017.12.11

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM375784.pdf

Refuse to File: NDA and BLA Submissions to CDER

拒绝存档：向CDER（药品评价和研究中心）进行的NDA（新药申请）和BLA（生物制品）申请

Guidance for Industry

行业指南

2017.12.12

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588242.pdf

Medications and Gluten

药物和谷蛋白

2017.12.12

出于对乳糜泻患者的考虑，含有谷蛋白的药物应标明。本网页含有相关问答，包括何种原辅料可能含有谷蛋白。并介绍了相关草案：

Gluten in Drug Products and Associated Labeling Recommendations

药品中的谷蛋白和相关贴标建议

https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/ucm410373.htm

网页给出了相关指南草案的链接：

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588216.pdf

Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs

系统性抗菌药物和抗真菌药物：为NDA和ANDA贴标的敏感性试验解读标准

Guidance for Industry

行业指南

2017.12.12

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588747.pdf

FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

为分享信息，帮助医生更好的进行抗生素使用的管理，提升对患者的服务，FDA推出了新的工具

2017.12.13

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588836.htm

FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 2017

FDA提醒药企在2017年12月31日前完成新药列表认证

2017.12.14

https://www.fda.gov/Drugs/DrugSafety/ucm589192.htm

Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Guidance for Industry

DRAFT GUIDANCE

2017.12.15

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588884.pdf

Drug Products, Including Biological Products, that Contain Nanomaterials

包含纳米材料的药品，包括生物制品

Guidance for Industry

行业指南

DRAFT GUIDANCE

指南草案

2017.12.15

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588857.pdf

Information Requests and Discipline Review Letters Under GDUFA

GDUFA法案下的信息请求和专业审评信件

Guidance for Industry

行业指南

DRAFT GUIDANCE

指南草案

2017.12.15

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588862.pdf

Manual of Policies and Procedures (MAPP) 5220.5

MAPP

Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications

简略新药申请（ANDA）信息申请（IR）和/或专业审评信件（DRL）的签发

2017.12.15

政策和规程手册（MAPP）规定了仿制药办公室（OGD）和药品质量办公室（OPQ）签发简略新药申请（ANDA）信息申请（IR）和专业评审信件（DRL）应如何进行。依照仿制药用户费用2017年增补案（GDUFA II）。

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM589271.pdf