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...
Once an NDA is filed, the FDA reviews the product label (package insert) to be sure the clinical information needed to safely use this drug is outlined. The FDA also takes action to inspect manufacturing plants where the drug will be made. PDUFA: Some companies will pay for an expedited N...
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...
The FDA’s approval process has garnered many criticisms over the years. For one, generic drugs and devices often make it to market simply because the manufacturers can demonstrate they are similar to products that were approved in the past — even if those products have known safety concerns....
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Drug Discovery TodayPatridge E, Gareiss P, Kinch MS, Hoyer D. An analysis of FDA- approved drugs: natural products and their derivates. Drug Disc Today, 2015; 21:204-7.Patridge, E.; Gareiss, P.; Kinch, M.S.; Hoyer, D. An analysis of fda-approved drugs: Natural products and ...
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。 2、检索条件支持模糊查询和组合查询,各条件间关系为逻辑与。例如在药品通用名或有效成分栏中输入Levofloxacin,即可查询...
The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results.
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。 2、检索条件支持模糊查询和组合查询,各条件间关系为逻辑与。例如在药品通用名或有效成分栏中输入Levofloxacin,即可查询...
美国食品及药物管理局(FDA)批准的药物生产设备(USFDAApprovedDrugsmanufacturingfacilities)数据摘要:FDAcurrentlyactiveandregistereddrugsdomesticmanufacturingfacilities.In2002,theFDAannouncedasignificantnewinitiativecalledPharmaceuticalCurrentGoodManufacturingPractices(CGMPs)forthe21stCentury,toenhanceandmodernizetheregulationofpharm...