首页 > 资讯 > OGD关于稳定性要求尚未作出的决定

出自识林

2014-07-22 Lachman CONSULTANTS

如果你是6月前19天提交的600件ANDA申请者中的一员，或者是在2014年6月之前提交ANDA但还没有收到接收通知的另外100-200件ANDA申请人之一，关于重新提交时你需要面对的稳定性要求的决定预计很快将会发出。之前关于这一问题的文章请见【6月20日之前本月ANDA递交数量已达600件 识林资讯】

每个人都在屏息静待有关OGD尚未作出的决定。我们在得知以后会尽快报道给大家。在此之前，竖起耳朵期待得到好消息吧! 这些都是重要的问题，很高兴得知OGD认识到有必要尽快对这些问题作出决定，从而企业可以有一些把握。我处于Hatch-Waxman游戏中已经30多年了，有一件我早就学会的事情是，事先没有办法回答所有问题或考虑到所有情形。只要看看像Mova案的决定让180天专营权陷入混乱的境地。另外的一个例子与NCE 5年奖励有关，考虑到组合产品时，仅需要组合中的一个药品之前从未获得批准即可。我们明白，仅一个法庭判例就可以改变先例，或重新考量先前FDA以新视角作出的或是企业提出的决定。因此，在仿制药审评和批准过程不稳定且不断变化的环境中，所做的改变将提出新问题，一些问题的答案将在法庭上被质疑，过往的判例将被修改。这不是胆小的企业或时代。这不是一个胆小的行业，也不是一个胆小的时代！

Lachman CONSULTANTS - Bob Pollock先生 2014-07-21
校译：识林-椒 2014-07-22

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OGD to Reach Decision Soon on Stability Requirements for RTR ANDAs First Submitted Before June 20, 2014
Written by Bob Pollock • July 21, 2014

If you are one of the about 600 ANDA applicants submitted in the first 19 days of June, or have one of the additional ~ 100-200 ANDAs that have not yet received notification of acceptance for ANDAs submitted prior to June 2014, a decision is expected soon on what stability requirements you will need to meet upon resubmission. This issue was previously raised in a blog post here.

Everyone is holding their breath relative to the OGD’s yet-to-be-made decision. We hope to report on it to let you know as soon as we find out. Until then, keep your ears to the ground and hope for the best!

These are important questions, and it is nice to know that OGD recognizes the need to make decisions on these issues quickly so the industry can have some certainty. I have been at the Hatch-Waxman game for over 30 years now, and the one thing I learned early on, is that there is no way to answer all of the questions or consider all of the scenarios that may come up in advance. Just look at the likes of the Mova decision that threw 180-day exclusivity into a tizzy. Another example relates to the 5-year award of NCE, when considering combination products, when only one of the drugs in the combination has never been approved before. We know it can take only one court decision to change a past precedent or reexamination of a previous decision in light of a new view at FDA, or as presented by industry. So, in this fluid and dynamic environment of the generic drug review and approval process, change will raise new questions, and some answers will be challenged in court or past precedents will be revised. This is not an industry or time for the faint of heart!