系列4：化学、生产和控制Chemistry,Manufacturing, and Controls
本部分收录了化学、生产和控制（CMC）相关的指南：
CMC主要是指药品生产工艺、杂志研究、质量研究、稳定性研究等药学研究资料，CMC申报是仿制药申报资料中非常重要的一部分。
4.1_ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)
4.1_ANDA：与优先仿制药申请相关的设施信息的预先提交(提交前的设施沟通)
发布日期：11/03/2017
目前状态：草案
The Food and Drug Administration (FDA) is issuing this revised draft guidance to describe the process through which prospective generic drug applicants seeking a priority review goal submit complete, accurate facility information in advance of submitting a priority original abbreviated new drug application (original ANDA), prior approval supplement (PAS), PAS amendment, or ANDA amendment (hereafter collectively referred to as ANDA).
FDA发布了此修正指南草案，以描述以下流程：
在提交优先权的原始ANDA申请，批准前补充申请(PAS)，PAS修正或ANDA修正(统称为ANDA)之前，对于寻求优先审查目标的潜在仿制药申请人，其应该如何提交完整、准确的设施信息。
4.2_Completeness Assessments for Type II API DMFs Under GDUFA
4.2_GDUFA下的II类API DMF的完整性评估
发布日期：10/11/2017
目前状态：定稿
This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).
本指南适用于II型活性药品成分(API)药品主文件(DMF)的持有者，该DMF已经或将在以下申请中被引用：ANDA，ANDA修正，ANDA批准前补充申请(PAS)或PAS修正(仿制药提交)。
4.3_ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
4.3_ANDA：药品固体多态性：化学、生产和控制信息
发布日期：07/09/2007
目前状态：定稿
Chemistry, manufacturing, and controls (CMC) information must be submitted to support the approval of an abbreviated new drug application (ANDA). This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms.
申请人必须提交化学、生产和控制(CMC)信息，以支持ANDA申请的批准。当某种药品以多晶型形式存在时，本指南旨在帮助申请人如何提交ANDA。
4.4_Changes to an Approved NDA or ANDA: Questions and Answers
4.4_NDA或ANDA批准后变更：问答指南
发布日期：01/01/2001
目前状态：定稿
This document provides questions and answers relating to the guidance on Changes to an Approved NDA or ANDA (the guidance). The questions are based on those posed to CDER by applicants. The questions and answers are presented using subject headings that correspond to the table of contents in the guidance.
本文件提供与已批准的NDA或ANDA变更指南有关的问答。这些问题基于申请人向CDER提出的问题。使用与指南中的目录相对应的主题词，来展示问答。
