点击Drug Master Files (DMFs) 药品主文件(DMFs),进入如下左侧界面,点击List of DMFs,进入如下右侧界面,可以查看DMF清单,每季度更新一次,DMF活动状态(A=激活;I=没激活)、DMF类型、持有人姓名和主题的变化都包括在内。
根据Federal Food, Drug, andCosmetic Act 的section 510 和21 CFR part207的规定,所有次从事药品的生产、制备、运输以及加工的企业需要进行注册(establishmentregistration),并提交所有已经上市销售产品信息(drug listing)。递交了establishmentregistration后,FDA会分派一个FEI 号 给企业。FDA工厂注册,即“Establishment Reg...
Topdrugnews位于“药品信息”栏顶栏，主要介绍热门品种 消费者药品信息 (ConsumerDrugInformation)内容十分详细，对药师回答病人的药品信息咨询，有很大参考 意义 药学信息资源重点栏目 FDA医学公告 (FDAMedicalBulletin)从事医药工业研究的科研人员可以从中得到很多启发 FDA消费者杂志 (FDAConsumerMagazine)宏观了解美国药品发展...
According to FDA, the proposal would make the complete listing of drug products accessible electronically and would clarify current regulations to be complied by the company.EBSCO_AspChemical & Engineering News
4、s New on This Site, Drug Approval Listing, Meetings and Conferences Science & Research (Drugs)(科学和研究)(药物)Research by FDA Staff to Evaluate and Enhance the Safety of Drug Products Resources for You (共享资源)For Consumers, Health Professionals, Industry在Spotlight栏中可以查询到药品信息...
Drug Establishments Current Registration Site Search药品经营机构现行注册网站查询 Drug Safety-related Labeling Changes (SrLC) 药品安全相关标签变更(SrLC) Drug Shortages药品短缺 Drugs@FDA Search药品@FDA搜索 已上市药品的信息可通过药品名称、原料药名称和申请号快速查询,也可通过药品...
A New York FDA consulting firm providing FDA Registration, FDA Labeling Compliance Assistance to Food, Dietary supplement, Medical Devices, Cosmetics and Drug
What's New on This Site, Drug Approval Listing, Meetings and Conferences Science & Research (Drugs)(科学和研究)(药物) Research by FDA Staff to Evaluate and Enhance the Safety of Drug Products Resources for You(共享资源) For Consumers, Health Professionals, Industry 在Spotlight栏中可以查询到药品...
Drug and Biologic Approval Reports Guidance, Compliance Regulatory Information (指南、和法规信息) Guidance for Industry, Warning Letters, Postmarket Surveillance Programs, Rules and Regulations News Events (新闻和活动) Whats New on This Site, Drug Approval Listing, Meetings and Conferences Science Research...
Please contact the Electronic Drug Registration and Listing System to register your firm:EDRLS@fda.hhs.gov 2.根据要求联系EDRLS@fda.hhs.gov后,回复如下: The establishment registration SPL file needs to be submitted for this location in order to assign the FEI number. Please follow the guidance pro...