//01 第一步：找到相关数据库打开浏览器，输入“FDA”进入或直接输入网址https://www.fda.gov/，进入FDA主页。下拉至页面最底部，选择“Drugs”，也可以直接输入网址：https://www.fda.gov/drugs。▲ 图-1 下拉至页面最底部，通过“图2”中“Drug Approvals and Databases”、“Drug Development and Review Pr...
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work...
打开浏览器,输入“FDA”进入或打开链接https://www.fda.gov/,进入FDA主页,如“图1” 图1 点击“图1”中“Drugs”进入药物检索页,网址:https://www.fda.gov/drugs,一般情况从“图2”中“Drug Approvals and Databases”可获取绝大多数FDA公开的原研药品信息。 图...
一、网站首页总览 官网入口https://www.fda.gov/,进入首页: 点击右上角menu,可清晰直观看到各个专栏内容: FEATURED (特色专题): 左侧特色专题一栏是关于FDA网站的特色业务介绍,具体如下: 1、Contact FDA 介绍如何联系FDA; 2、FDA Guidance Documents (可查询指南性文件,如指导原则、法规等)这里提供一个方便的方...
点击“图3”中“Dissolution Methods DatabaseSearch”,进入溶出方法数据库检索页面,网址:https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm,如“图9”所示进行精确检索或模糊检索。 图9 点击“图9”中“Printable List of All Drugs in the Database”,进入模糊查找页,可点击“图10”中“EXCEL...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals 3.https://www.fda.gov/media/...
2.https://www.fda.gov/media/172696/download 3.Adrian Sacher,M.D.et.al,Single-Agent Divarasib(GDC-6036)in Solid Tumors with a KRAS G12C Mutation,N Engl J Med 2023;389:710-21.4.https://aacrjournals.org/cancerres/article/83/8_Supplement/CT030/725402/Abstract-CT030-Phase-I-study-of...
1. https://edm.fda.gov/。 2. 一两天内就会收到FDA的分配号。 三、电子递交(ESG WebTrader) 1. 签署Non-Repudiation Letter(模板见附件) 2. https://esgportal.fda.gov/ 3. Signing certificate 1)生成Digital Certificate:浏览器出现下载的文件 .pfx格式,保存后用于每次的递交。 2)申请ESG 账号后,FDA一...
https://fabrekramer.com/fabre-kramer-pharmaceuticals-announces-fda-approval-of-exxua-the-first-and-only-oral-selective-5ht1a-receptor-agonist-for-the-treatment-of-major-depressive-disorder-in-adults/ ② Novel Drug Approvals for 2023 https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-...
1.https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression 2.https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.20220785 3.https://www.nytimes.com/2023/08/04/health/postpartum-depression-pill-fda.html 4. https://www.cnn.com/2023/08/...