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FDA仿制药指南汇编-信函与会议

系列8:信函与会议Correspondence and Meeting本部分收录了信函与会议相关仿制药沟通指南:·对于仿制药的注册与上市,在将产品推向美国市场的过程中,一个很重要的环节就是
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系列8:信函与会议Correspondence and Meeting

本部分收录了信函与会议相关仿制药沟通指南:
·对于仿制药的注册与上市,在将产品推向美国市场的过程中,一个很重要的环节就是与FDA的沟通互动。FDA十分重视与其所监管的行业之间的沟通,因为沟通能够有效地促进申请人了解法定流程与要求,即通过沟通有效地实现期望目标,如提交满足要求的注册资料,避免申报资料被拒收等。

8.1_Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments

8.1_GDUFA背景下,FDA与ANDA申请人之间的回复信会议

发布日期:12/04/2018
目前状态:定稿
This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II).
本指南旨在阐明启动完整回复函(CRL)后会议要求的标准,以及会议讨论范围。本指南提供程序,促进管理良好CRL后会议的召开,并有助于确保按照FDA与GDUFA II(2018-2022财年仿制药使用者费用修正案的重新授权)有关的承诺,安排和召开此类会议。

8.2_Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments

8.2_GDUFA背景下,信息要求函和学科审评函

发布日期:12/22/2017
目前状态:草案
This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the review of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), as contemplated in the Generic Drug User Fee Amendments of 2017 (GDUFA II).
根据FD&C法案第505(j)条,以及 2017年仿制药使用者费用修正案(GDUFA II)背景下,本指南说明了FDA在对原始ANDA进行审评期间,将如何发布和使用信息要求函(IR)、和/或学科审评函(DRL)。
This guidance does not apply to an amendment made in response to a Complete Response Letter (CRL), a supplement, or an amendment to a supplement.
本指南不适用于对“完整回复函”(CRL)做出的修正、增补或对增补的修正。

8.3_Controlled Correspondence Related to Generic Drug Development

8.3_与仿制药开发有关的受控信函

发布日期:11/03/2017
目前状态:草案
This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development.
就仿制药开发这一主题,针对仿制药生产商、相关行业或其代表,本指南提供了其可以向FDA提交受控信函信息的流程。
This guidance also describes the Agency’s process for providing communications related to such correspondence.
本指南还介绍了FDA提供与此类信函有关的沟通的流程。

8.4_Requests for Reconsideration at the Division Level Under GDUFA

8.4_GDUFA背景下,要求在部门级别进行复议

发布日期:10/12/2017
目前状态:草案
This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
本指南为行业提供了解决程序,解决FDA与ANDA申请人之间的科学和/或法规问题或事宜,此时ANDA申请人希望在部门级别或原签署机构的审查学科内提出重新考虑请求。
This guidance does not describe the formal dispute resolution procedures for resolving scientific and/or regulatory disputes between FDA and sponsors or applicants that cannot be resolved through the request for reconsideration process at the division level. This guidance also does not describe the procedures for resolving administrative matters, such as disputes regarding user fee assessments.
本指南并未描述解决FDA与发起人或申请人之间科学和/或法规纠纷的正式纠纷解决程序,这些程序无法通过部门级的重新审议程序解决。本指南也没有描述解决行政事务的程序,例如有关使用费评估的争议。

8.5_Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

8.5_GDUFA背景下,FDA和复杂产品ANDA申请人之间的正式会议

发布日期:10/03/2017
目前状态:草案
This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has submitted an abbreviated new drug application (ANDA) for a complex product to FDA as defined in this guidance.
本指南描述了FDA与申请人之间讨论的增强途径,申请人就复杂产品(本指南定义),准备申请或已申请ANDA。
Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.
具体来说,该指南提供了有关与FDA请求与召开相关会议的信息,包括产品开发会议,提交前会议以及中期审查周期会议。

8.6_Controlled Correspondence Related to Generic Drug Development

8.6_仿制药开发相关的受控通信

发布日期:09/29/2015
目前状态:定稿
This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence. FDA is issuing this guidance as part of its implementation of the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.
仿制药生产商和相关行业可以向FDA提交信函,以请求与仿制药开发相关的信息,对此本指南提供了流程信息。本指南还介绍了FDA提供与此类信函有关的通信流程。 为实施2012年仿制药使用者费用修正案(第112-144号公共法,第III条)(通常称为GDUFA),FDA发布了该指南。

8.7_How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

8.7_如何获得FDA的信函:其中指出BE研究草案包含的安全保护与RLD适用的REMS相当

发布日期:12/08/2014
目前状态:草案
This guidance describes how a prospective abbreviated new drug application (ANDA) applicant may request a letter stating that FDA has determined:
本指南描述了潜在的ANDA申请人如何要求信函,说明FDA已确定:
(1) that the prospective applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD), and
(1)潜在申请人的生物等效性(BE)研究方案包含的安全保护措施,与风险评估和缓解策略(REMS)中的安全保护措施相当,并带有确保适用于参比制剂(RLD)的安全使用(ETASU)的元素,
(2) that FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA.
(2)FDA不会认为RLD赞助商违反了REMS,其向感兴趣的仿制药公司或其代理商提供足够数量的RLD,以允许该公司执行支持其ANDA的必要测试。
发布于 2020-07-06 15:59:43 © 著作权归作者所有
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