首页 > 资讯 > 505(b)(2)的PDUFA费 – 全价还是半价？

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2016-02-09 Lachman CONSULTANTS

大多数人都知道当一件505(b)(2)申请包含临床研究结果而不是生物等效性研究，申请将需要缴纳完整的PDUFA使用者费。然而，如果你递交一件依据公开发表的临床研究的505(b)(2)申请，你的申请也需要缴纳完整费用吗？看起来FDA可能正在修订其法定解释，这样如果需要审评潜在临床数据，即使来自于公开发表的文献，而不是仅仅依赖于过去FDA对安全性或有效性的发现，你可能需要支付“完整费用”。还不知道FDA是否打算尽快正式确定这项政策，但是当递交505(b)(2)申请时请小心，与审评部门讨论递交的费用问题以确定是否需要以较高付费递交。

虽然这是有道理的，因为FDA必须对申请人所依据的潜在临床数据进行审评，但事实是，往年递交的一些505(b)(2)新药申请可能仅需支付一半的费用。请注意，FDA对于这方面的评价工作变得更加认真，同时请确保你的银行账户中拥有足够的资金！

Lachman CONSULTANTS - Bob Pollock先生
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PDUFA Fees – 505(b)(2) – Full Fee or Half Fee – Be Sure to Budget for the Worst Case
By Bob Pollock | February 8, 2016

Most know that when a 505(b)(2) contains the results of a clinical study other than a bioequivalence study, the application will be assessed a full PDUFA user fee. However, did you know that if you file a 505(b)(2) application that relies on published clinical studies, your application may also be subject to the full fee? It appears that FDA may be revising its statutory interpretation such that if there is a need to review underlying clinical data, even if it is from published literature, rather than just relying on previous Agency findings of safety or effectiveness you may need to pay the “full monty”. It is not known if the FDA is going to formalize this policy any time soon, but take care when submitting a (b)(2) and discuss the fee implications of your submission with the review Division to determine if you need to submit with the higher fee.

While this makes sense, since the FDA must review underlying clinical data upon which the applicant is relying, the fact is that a number of (b)(2) NDAs submitted in previous years may have skirted by with a half fee. Just note that FDA is becoming more diligent about their assessment practice in this regard and make sure your bank account has sufficient funds!