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FDA对于搞新药研发及药品注册者有着深远的意义。假若能够熟练的使用FDA网站的各个通路，必然会对将来的工作和研究带来诸多便利。 但是，FDA是一个内容繁多的数据库，系统全面掌握并不容易，需要不断的积累与交流。 鉴于以上原因，本人想寻求有志于认真学好FDA相关知识的朋友一起学习，共同奋斗，互相监督，互相勉励，达到共赢。 再接下来的时间里，我会每个星期至少花15个小时。学习期限是，直到能熟练运用为止。 希望有共同目的的朋友，请回帖或者加 QQ646828723 请注FDA字样。谢谢！！ [ Last edited by wiggle on 2007-5-8 at 20:27 ] |
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一下内容转载自 Dxy 稀糊醋鱼版主的FDA Learning（咖啡馆） [精华] 帖子 链接为 http://www.dxy.cn/bbs/post/view? ... 1&age=0#3164550 FDA宝库之一 List of Orphan Designations and Approvals http://www.fda.gov/orphan/designat/list.htm Drug Lists--A cumulative list of designated orphan products, updated monthly, includes product sponsors, designated or approved use, and dates of product designation and marketing Cumulative list of all products that have received Orphan Designation Cumulative list of all Orphan Designated Products that have received Marketing Approval List of all products that have received Orphan Designation year-to-date List of all Orphan Designated Products that have received Market Approval, year-to-date List of all products that have received Orphan Designation in the past month List of all Orphan Designated Products that have received Market Approval in the past month FDA宝库之二 OTC Drug Product List Prescription Drug Product List http://www.fda.gov/cder/rxotcdpl/pdplarchive.htm Additions/Deletions for Prescription and OTC Drug Product Lists This document is not a cumulative list of approved Prescription and OTC Drug Products but a list of the new additions and new deletions to the Prescription and OTC Drug Product Lists for a specific month. This information must be used in conjunction with the most current Cumulative Supplement and Orange Book. Additions and deletions are identified in this document by the symbols >ADD> and >DLT>, respectively. Products that have never been marketed, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a "@" symbol in the 12th Cumulative Supplement of the 27th Edition List will then be added to the "Discontinued Drug Product List" appearing in the 28th Edition. FDA宝库之三 Drug Specific Information（药物的相关信息） http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm FDA is in the process of updating its drug safety information and making it available to consumers in a new, user friendly format. Under the new format, clicking on a drug takes you to a "core page" with links to all information on that drug available on the FDA site. If you click on a drug whose information is not yet in the new format, you will reach a single information page on that product. Drug Information http://www.fda.gov/cder/drug/default.htm 包括如下几部分： (1)New Prescription Drug Approvals：报告新批准处方药物。 New and Generic Drug Approval：按字顺排列1998~2001年批准的处方药物，每日更新，提供药物商品名、生产厂商、批准号、批准日期等信息，同时提供与药品标签、批准函及评论的链接。 FDA Drug Approvals List：是自1996年按时间由近及远顺序排列的FDA批准药物列表。每周更新。 New Drugs Approved for Cancer Indications；报告新批准的抗肿瘤药物。 (2)Prescription Drug Information：报告处方药物信息。 Approved Drug Products with Therapeutic Equivalence Evaluations／Orange Book：橙皮书收录FDA批准的所有处方药物，包括新药及不注册药品。每月更新。橙皮书提供3种报告：①电子版橙皮书；可以通过药物活性成分、专利名等多种角度查询FDA批准的药物，与文本版及增补部分同时更新。②文本版橙皮书：据此识别FDA依据联邦食品、药物、化学品法案，按照安全及有效的原则批准的药物产品。目前最新版本为Orange Book-2lstAnnual Edition。③橙皮书累积增补本；提供新近批准的药物信息，对当前数据包括治疗等价评价、最新专利及专有数据的更新及修正。橙皮书每月还提供修改本，将对文本版橙皮书的修改(增加及删除)按月份列出。National Drug Code(NDC)Directory 药物代码是公认的人类药物识别符，当前版本药物代码指南仅包括处方药物及部分非处方(OTC)药物. National Drug Code Directory Searchable Database：是NDC指南的专门数据库．可通过专利名、NDC代码、药物活性成分、公司名4种途径检索。 (3)Major Drug Information Pages：报告一些主要大类药物信息. (4)Consumer Drug Information：针对消费者报告药物信息。 (5)Over-the-Counter Drug Information：报告OTC药物信息。 (6)Drug Safety & Side Effects：报告药物安全及副作用信息 其中MedWatch是FDA药物安全信息及副作用报告程序专门网站. (7)Public Health Alerts & Warning Letters：公共卫生警告。 (8)Reports＆PublicationsFirst Data Drug Database:报告及出版物。 (9)Special Projects & Programs：专门研究课题及项目. CDER与药物监控工作有关的信息，由其主页中的Regulatory Guidance部分提供。在此可以得到与药物监控有关的指导性文件及法律法规，如可检索的指导性文件数据库、CDER数据标准手册、申请药物证明书指导等。 Orange Book http://www.fda.gov/cder/ob/default.htm 橙皮书收录FDA批准的所有处方药物，包括新药及不注册药品。每月更新。 ①The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number. The data is updated concurrently with the publication of the annual edition or cumulative supplements. 电子版橙皮书；可以通过药物活性成分、专利名等多种角度查询FDA批准的药物，与文本版及增补部分同时更新。 Orange Book Annual Edition http://www.fda.gov/cder/ob/docs/preface/eclink.htm ②The publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act 文本版橙皮书：据此识别FDA依据联邦食品、药物、化学品法案，按照安全及有效的原则批准的药物产品。 Orange Book Current Cumulative Supplement http://www.fda.gov/cder/ob/docs/preface/eclink.htm ③The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data. 橙皮书累积增补本；提供新近批准的药物信息，对当前数据包括治疗等价评价、最新专利及专有数据的更新及修正。橙皮书每月还提供修改本，将对文本版橙皮书的修改(增加及删除)按月份列出。 [ Last edited by wiggle on 2007-5-10 at 22:26 ] |
13楼2007-05-10 22:20:29
DMFluhui
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2楼2007-05-08 21:32:33
3楼2007-05-08 21:51:01
WANTTOKNOW
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4楼2007-05-08 23:24:53