[1] Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC. Retrieved December 8, 2023, from https://www.ipsen.com/press-releases/ipsen-confirms-u-s-fda-grants-priority-review-for-new-drug-application-...
点击上图中“Patent and Exclusivity Information”，可得到原研专利信息。以下结果表明，Appl No.N020829药物无原研专利。▲ 图-16 2.4 Inactive Ingredient Search for Approved Drug Products Search（被批准药物的非活性成分数据库）点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”...
1) 点击“图29”中“New Drugs at FDA”可获得2015年～2022年FDA批准的新药。 ▲图-30 ▲图-31 2) 点击“图29”中“First Generic Drug Approvals”,可检索首个仿制药批准信息。点击药物名称,即可进入该药物的“Drugs @FDA Search”界面,可检索更多药物信息。 ▲图-32 2.9 USDMF号查询在FDA网站(fda.gov...
点击“图3”中左侧“Resources for Information on Approved Drugs”,下拉至最底部,界面如下。 ▲图-29 1) 点击“图29”中“New Drugs at FDA”可获得2015年～2022年FDA批准的新药。 ▲图-30 ▲图-31 2) 点击“图29”中“First Generic Drug Approvals”,可检索首个仿制药批准信息。点击药物名称,即可进入...
Expected US New Drug Approvals in June 2022 Ahead of us in June,it is anticipated FDA will make decisions on the following four drugs. Drug: spesolimab Company: Boehringer Ingelheim Indication: generalized pustular psoriasis Boehringer Ingelheim’s spesolimab is a humanized, selective antibody th...
点击Updates, News, Events, and Training,出现下方界面,共包括Recent New and Generic Drug Approvals(近期新药和仿制药批准进展)、Meetings, Conferences, & Workshops(CDER组织的会议和研讨会)、CDER Learn Training and Education(CDER组织的培训学习和继续教育机会)、Notable Approvals | Drugs(值得关注的人体药物批...
FDA网站地址: 知乎用户 另外,在FDA官网上还有这些常用信息 1.药品说明书(结构式、剂型、适应症、副作用、药理机制等) 查询方法: 主页→Drug→Spotlight→Drug Information (Drugs@FDA) →检索→Label Informa…
Drug Information, Safety, and Availability:药物警戒、召回等安全性信息; Drug Approvals and Databases:药品批准情况和数据库; Drug Development and Review Process:药品申报和审评流程; Guidance, Compliance, and Regulatory Information:指南、合规性和监管信息; ...
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 ...
Current FDA-Related Drug Information - New Drugs Approved by the FDA; New Dosage Forms and Indications Approved by the FDA; Agents Pending FDA Approval; New Drug Applications Filed by Manufacturer; Supplemental Applications Filed by Manufacturer; Significant Labeling Changes or 鈥淒ear Health Care ...