产品号批准日期Product Number Approval Date- 数据库说明: 1、本数据库涵盖了至目前为止所有经美国食品药品管理局(U.S. Food and Drug Administration)批准在美国上市或曾经上市的全部药品,可查询FDA批准的药品审批注册信息及相关文件、专利数据、市场保护等。
Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases. Brief Bioinform 2011; 12(4): 341-5.Xu K, Cote T (2011) Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases. Brief Bioinform 12: 341-...
5 days ago New Drug Approvals FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Treatment of Diabetic Macular Edema February 4, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food an...
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2 点击“图2”中的“Drug Approvals and Da...
结果与结论:在检索功能上,以DailyMed最丰富;在检索结果显示内容上,DailyMed的数据格式化程度最高,FDA Online Label Repository次之,而Drugs@FDA只进行了部分格式化;3个数据库都提供页面复制和打印的功能,其中DailyMed的界面更为友好、内容更开放、提供了全部下载功能;在数据来源与服务目标上,Drugs@FDA和FDA Online Label...
What is the FDA approval process? The 4 phases of a drug approval process includes: Pre-clinical, IND (Investigational New Drug) Application Clinical New Drug Application (NDA) Review Post-marketing risk assessments The U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation an...
fda.gov 相似文献The New Drug Approvals of 1990, 1991, and 1992: Trends in Drug Development Efforts to speed the development and review of new drugs have increased sharply in recent years. This report, which is the third in a series on trends in d... Kenneth,I.,Kaitin,... - 《Journ...
To identify and quantify factors associated with patient accrual in trials leading to the US Food and Drug Administration (FDA) approval of new cancer drugs. Data All anti-cancer drugs with FDA approval were identified in the Drugs@FDA database (2000–2022). Data on drug indication’s backgro...
FDA Drug-Approval Process A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring. ...
by the FDA between January 1, 2001, and December 31, 2010. They then separated the drugs on the basis on seven prespecified features: class (pharmaceutical, biologic), therapeutic area, priority review, accelerated approval, orphan product, near–regulatory deadline approval, and total review ...