仿制药办公室正在出台更多指南
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仿制药办公室正在出台更多指南
笔记 2014-02-25 Lachman CONSULTANTS 仿制药办公室正在出台更多指南 这些即将出台的新文件旨在阐明GDUFA的工作方式，包括申请提交和工作流程。 有望出台的五个文件分别是： 有一个不同寻常的暗示，可能会修订MaPP 5200.3，“回应产业界对仿制药办公室简化新药申请有关问询”。如果这真的发生，因为MaPPs通常解释FDA内部做事的方式，基于产业界和仿制药生产商协会（GPhA）的意见进行的修订将变得很不寻常。 此外，在对承担项目现状问询回应方面，仿制药办公室承认，对每个公司的申请应排在队伍的哪个位置提供快照所走的流程，并未像公司所期望的那样有足够的清晰度，由于已经超出了GDUFA的要求，对于这项工作，产业界应给予仿制药办公室信任来启动这一项目。仿制药办公室还有可能为很多申请设定目标日期，作为一种看他们如何满足这些日期的操演。如果发生这种情况，公司将收到一份说明目标日期的信函，对接着到来的会是完全回应函、暂时性批准或者批准，公司就会有所预期。 仿制药办公室一直倾听来自产业界的声音，但对某些事情，也只能有所为，有所不为。他们将尝试那些可行的，但是不会尝试实施那些不可行的。 Keith表示，仿制药办公室对联邦快递（FedEx）应用的跟踪概念有意，能将他们从状态更新的工作中解脱出来，但是基于现有的IT构造，这可能会成为GDUFA II中才能商谈的事情。 Lachman CONSULTANTS - Bob Pollock先生 2014-02-19 More Guidance on the Way from Office of Generic Drugs, and Other Nuggets At today's Science and Regulatory Advisory Committee meeting at the GPhA Annual Meeting in Orlando, Florida (apologies to those in the mid-West and Northeast), Keith Flanagan, the Office of Generic Drugs' (OGD) Regulatory Counsel provided a look into some guidance documents the industry can expect to see in short order. The roll out is designed to clarify how GDUFA is going to work, regarding submissions and work flow. The five documents to expect are: 1) A Prioritization MaPP, which will outline OGD' s internal procedures for how Regulatory project managers and their supervisors will assign priorities across the workload. The document will describe issues, such as public health priority review, how OGD will treat First-to-File applications, Paragraph IV and III applications, etc. 2) Guidance on the Quality of 505（j） Applications-but we were warned not to expect anything novel or new. Hopefully, the document will provide some useful tips on improving quality of applications. 3) An ANDA Amendment Tier Guidance to help clarify the relatively confusing portion of the statute and GDUFA goals metrics as they apply to amendments to pending applications. Keith asked that the industry remember that, upon issuance of the second major amendment, there are no goal dates associated with the application, and thus, told the meeting attendees to assure the quality of their submissions. 4) Supplemental Guidance to describe how Prior Approval Supplements will be treated under GDUFA 5) Controlled Correspondence Guidance that will define what a controlled correspondence is and what it isn' t. There was a hint that, in an unusual move, there may be a revision of MaPP 5200.3, “Responding to Industry Inquiries with respect to Abbreviated New Drug Applications in the Office of Generic Drugs”. If this does occur, a revision based on some industry and GPhA comments will be very unusual since MaPPs typically explain the way FDA does things internally. Also, in responding to questions about the status project that was undertaken, OGD acknowledged that the process they went through to provide a snapshot of where each company’s application was in the queue may not have provided as much granularity as firms had hoped, and that it was an effort for which the industry should give credit for OGD initiating this project, as it was over and above the requirements of GDUFA. OGD will likely also begin assigning target goal dates to many applications as a practice exercise to see how they do in meeting those dates. If this occurs, the firm will receive a letter stating the target goal date, so firms may have a heads up that either a Complete Response Letter, Tentative Approval, or Approval may be coming. OGD has heard the industry, and there are certain things they can and certain things they cannot do. They will attempt the feasible, but will not attempt to implement wants that are not feasible. Keith said that OGD likes the FedEx tracking concept for application that may get them out of the status update business, but based on the current IT structure, this may be something for GDUFA II that can be negotiated. 相关链接 |