【讨论】the new FDA "Refuse-to-Receive"

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当仿制药审查提交申请，要求授权美国食品与药物管理局（FDA ）注重完整性和符合一定的标准。如果应用程序不符合标准或者甚至是不完整的， FDA的“办公室仿制药” （ OGD ）处理这些申请会拒绝他们的接待。该海域建业曾在总共497 “简化新药申请” （ ANDA）在2009年和2012年期间拒绝的事实，导致有权发布指导意见草案，供业界题为“安达提交 - 拒绝对接收标准” 。本文档发布于2013年10月，并发布了30天意见。
在下面的章节主要指导解释说，导致申请被拒绝的原因：

•一般准则
•在标签错误
•第二类错误的API主动药物主文件以及有关的活性物质的错误信息
•在应用程序的管委会部分缺陷
•缺点是关于生物等效性及临床试验
除了有关的活性成分或辅料延迟缴费的也可以导致驳回申请的裁定不正确的信息 - 即使是一个原本正确地设置了档案！ GDUFA - - 有关费用一般应用规则只生效于2012年10月，要求支付费用，直到提交后至少20天。由于FDA的问题没有任何法案，这一时期有时会忘记（权力已经在这方面发出警告信） 。支付的药物主文件的费用也同样重要和必要按照GDUFA 。如果该费用尚未支付，该DMF不会成为可供参考列表和通用许可申请的处理，犹如DMF基本上是“不存在” 。
该“设施费”是另一个GDUFA费每年支付。如果不按时支付，这也导致申请被拒绝。本网站收费是支付2013年3月的2013财年和2013年10月的2014财年。日前，美国食品药品管理局已经公布的公司名单就其GDUFA状态。哪些公司已经支付或不再需要收费这GDUFA设施拖欠Listprovides信息。更多的最新名单显示，经过自我认同已经完成了他们的职责（也GDUFA的需求）的所有企业。这种“自我鉴定的设施清单”为财政2014年名单共3777幅完整的地址。When reviewing submitted applications for authorisation for generics the US Food & Drug Administration (FDA) pays attention to completeness and compliance with certain standards. If the applications do not meet the standards or are even incomplete, the FDA's "Office of Generic Drugs" (OGD) processing these applications denies their reception. The fact that the OGD had to reject in total 497 "Abbreviated new Drug Applications" (ANDA) in the period between 2009 and 2012, led the authority to publish a draft guidance for industry entitled "ANDA Submissions - Refuse-to-Receive Standards". This document was published in October 2013 and was released for comments for 30 days.
In the following main chapters the guidance explains the reasons that lead to the rejection of an application:

•General guidelines
•Error in the labelling
•Incorrect type II active API Drug Master File and erroneous information concerning the active substance
•Deficiencies in the CMC section of the application
•Shortcomings with regard to bio-equivalence and clinical trials
In addition to incorrect information regarding the active ingredient or the excipients a delayed payment of fees can also result in a rejection of the application - even with an otherwise correctly set up dossier! The rules relating to fees for generic applications - GDUFA - which only became effective in October 2012, calls for the payment of fees until at least 20 days after filing. Since the FDA issues no bills, this period is sometimes forgotten (the authority already issued Warning Letters in this regard). The payment of the fees for a Drug Master File is equally important and necessary in accordance with GDUFA. If this fee was not paid, the DMF does not become available for the reference list and the generic authorisation application is handled as if the DMF were basically "non-existent".
The "facility fee" is another GDUFA fee to be paid per year. If it is not paid on time this also leads to the rejection of the application. This site fee was payable in March 2013 for the fiscal year 2013 and in October 2013 for the fiscal year 2014. A few days ago, the FDA has published a list of companies in relation to their GDUFA status. This GDUFA Facility Arrears Listprovides information about which companies have already paid or are no longer subject to charges. A more current list shows all companies that have done their duty after self identification (also a demand of GDUFA). This "Self Identified Facilities List" for the fiscal year 2014 lists a total of 3777 sites with complete address.