FDA发布ANDA和505(b)(2)申请拟议规定
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FDA发布ANDA和505(b)(2)申请拟议规定
笔记 2015-02-06 Lachman CONSULTANTS FDA发布《ANDA和505(b)(2)申请拟议规定》（长达371页！）修订其监管规定，并实施医疗现代化法案（MMA）第XI章。FDA采取该措施是因为自法案通过后一直是直接监管，而且有助于FD&C法案的遵守和有效实施，并根据最近的法院判决和505(b)(2)和ANDA批准相关规定实施的经验，阐释并更新这些法规。 拟议规定涉及修订定义、专利信息提交、专利认证、IV段认证通知规定、认证修正以及申请的增补和补充申请。还涉及再颁专利认证，这是最近法院判决不利于FDA的主要内容。 拟议规定还涉及不同药品505(b)(2)申请的增补或补充，以及不同参照药品ANDA的增补或补充。其中有叙述改变参照药品请愿、提交NDA、接收ANDA、修改批准和拒绝批准规定、包括专利和专营权以及启动批准的问题，还有涉及45天时钟和暂时批准转换为最终批准的问题。 文件还涉及某些生物利用度和生物等效性的要求，包括不被吸收或不用于吸收入血液产品的要求。 看起来有很多解释过去数年间FDA根据法律监管的细节将最终被编撰成文。如上所述，文件长达371页，而我们刚刚开始研究。在接下来的几周，我们将进一步提供我们看到的最明显的监管问题和规定。 Lachman CONSULTANTS - Bob Pollock先生 2015-02-05 371 Page Proposed Rule for Implementation of MMA ANDA and 505(b)(2) Provisions Today, the FDA published a Proposed Rule (371 pages!) to amend its regulations and to implement Title XI of the Medicare Modernization Act (MMA). FDA is taking this step because it has been regulation directly from the statute since its passage, but also to facilitate compliance with and efficient enforcement of the FD&C Act, and to clarify and update these regulations based on recent court decisions and our practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs. The Proposed Rule addresses revised definitions, the submission of patent information, patent certifications, the notice provisions of paragraph IV certifications, amendments to certifications as well as amendments and supplements to applications, . It also addresses certifications for reissue patents, which was the subject of a recent court decision unfavorable to the FDA. The Proposed Rule also addresses amendments or supplements to a 505(b)(2) application for a different drug and amendments or supplements to an ANDA that reference a different listed drug. There are sections that describe petitions to change a listed drug, filing an NDA and receiving an ANDA, revisions to the approval and refuse-to-approve regulations, issues covering patents and exclusivity and the approval triggers as well as issues addressing the 45-day clock and conversion of a tentative approval to final approval. The document also addresses certain bioavailability and bioequivalence requirements including the requirements for products not absorbed or not intended to be absorbed into the blood stream. There is likely to be a lot of detail that explains how the FDA has been regulating from the statute over these past number of years that will finally be codified. As noted above, the document is 371 pages long and we are just starting to dive into the document (which can be found here 解读法规指南 适用岗位：
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). Over the next couple of weeks, we will provide further posts outlining some of what we see as the most significant regulatory issues and provisions..