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FDA原辅包登记*DMF

药物主文件,即Drug Master File (DMF),是呈交FDA的存档待审资料,资料内容包括有关在制造、加工、包装、储存、批发人用药品活动中所使用的生产设施、工艺流程、质量控制及其所用原料、包装材料等详细信息。

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FDA官网

FDA是食品药品监督管理局(Food and Drug Administration)FDA由美国国会即联邦政府授权,是专门从事食品与药品管理的最高执法机关,也是一个由医生、律师、微生物学家、化学家和统计学家等专业人士组成的致力于保护、促进和提高国民健康的政府卫生管制的监控机构。

橙皮书历史档案

美国橙皮书的历史文件下载1980-2021 THE ORANGE BOOK ARCHIVES 1979 – Proposed Version 1980 – 1st Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12; Supplement 13 1981 – 2nd Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1982 – 3rd Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1983 – 4th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1984 – 5th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1985 – 6th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12; Supplement 13; Supplement 14; Supplement 15; Supplement 16 1987 – 7th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1988 – 8th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1989 – 9th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1990 – 10th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1991 – 11th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1992 – 12th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1993 – 13th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1994 – 14th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1995 – 15th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1996 – 16th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1997 – 17th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1998 – 18th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 1999 – 19th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2000 – 20th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2001 – 21st Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2002 – 22nd Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2003 – 23rd Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2004 – 24th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2005 – 25th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2006 – 26th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2007 – 27th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2008 – 28th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2009 – 29th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2010 – 30th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2011 – 31st Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2012 – 32nd Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2013 – 33rd Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2014 – 34th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2015 – 35th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2016 – 36th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2017 – 37th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2018 – 38th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2019 – 39th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2020 – 40th Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7; Supplement 8; Supplement 9; Supplement 10; Supplement 11; Supplement 12 2020 – Special BPCIA Transition Edition List of Withdrawn Applications for Biological Products That Were Removed From FDA’s Orange Book on March 23, 2020 List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 2021 – 41st Edition Supplement 1; Supplement 2; Supplement 3; Supplement 4; Supplement 5; Supplement 6; Supplement 7;

Drugs

Drugs@FDA包括有关药物,包括生物制品,信息批准在美国,但不包括有关被监管FDA批准的产品信息中心生物制品评价和研究

FDA橙皮书

橙皮书即《经过治疗等效性评价批准的药品》(Approved Drug Products with Therapeutic Equivalence Evaluations),简称Orange Book,收录经由FDA审批的全部药品。 橙皮书详细完整的列出了在《食品、药品和化妆品法》指导下,历年来根据其安全性和有效性批准的所有药品。其中最重要是明确列出新药所涉及的所有专利以及市场专营保护信息。 印刷出版的“橙皮书”在每年三月发行,将过去一年内FDA所批准的药品及其专利和保护其信息更新。除年度更新外,fda还出版“橙皮书”的积累增刊(cumulative supplement),将当年积累的药品信息按月更新发表。从药品批准到列入橙皮书,一般有三周的滞后时间。 为帮助业界在仿制药质量和疗效一致性评价工作中选择参比制剂,经美国FDA驻华办同意,仿制药质量一致性评价办公室组织翻译了美国FDA橙皮书(经过治疗等效性评价批准的药品)的相关内容,现将翻译内容上网发布,供业界查询、参考。 本次翻译旨在为一致性评价工作提供信息参考和借鉴,译文使用者不得以盈利为目的进行商业化活动。

FDA最新批准药物

此报告显示从下列最早日期开始的两周内原始和补充申请的最终批准和暂定批准。在此时间跨度之后,某些批准可能会添加到 Drugs@FDA 数据库中。如需全面的批准报告,请使用Drugs@FDA 上的月度“所有批准”报告。