2024年12月31日 · CDER/CBER, September 2023 Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or …

2019年6月12日 · 化学、生产与控制（CMC）是新药申请（NDA）中非常重要的部分，CMC信息包括制剂的物理和化学特性、生产商名称和地址、成分与组分、生产与包装、主生产记录、质量标准、稳定性、批准后承诺等信息。

Learning Objectives Understand the regulatory definitions and requirements for drug substances and drug products Describe Chemistry, Manufacturing, and Controls (CMC) information for IND...

2023年12月18日 · CMC（Chemistry Manufacturing & Control）是药物申报中非常重要的部分，其始于通过药物发现确定一个先导化合物，并贯穿于药物开发全生命周期的所有阶段。 药物研发时间长、投入大、风险高。 药物开发流程主要包括：靶点确定、discovery、临床前药学研究（IND）、临床实验（临床I、II、III期）、NDA/BLA、上市。 CMC研究主要包括生产工艺、杂质研究、质量研究及稳定性研究等。 不同阶段的CMC研究重点均有所不同。 在临床前和早期临床研究阶 …

2025年1月15日 · 课程紧密围绕FDA的监管期望，深入拆解新药研发的CMC全过程，涵盖IND、NDA、CTD、DMF的CMC要求，讲解CTD和eCTD申报、与FDA会议准备、CMC现场核查及批准后变更等重点内容。

2017年5月5日 · FDA requires all sponsors of investigational new drug products (DPs), including investigational gene therapy products, to describe the CMC information for the drug substance (DS) (21 CFR 312.23(a...

2024年12月10日 · Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug quality, safety, and efficacy. In this blog, we demystify the CMC section of NDA preparation, providing insights and guidance for …

2010年4月14日 · Evidence to support proposed chemical structure, including stereochemistry. Use same lot of reference standards for characterization. radionuclide (if obtained from a vendor) should be included. Specifications should include acceptance criteria for identity, assay, and impurities, and other appropriate quality attributes (e.g., water content).

2023年7月1日 · CMC programs often need to be well developed owing to accelerated development. The 505 (b) (2) NDA pathway can reduce drug development costs and accelerate the time to market by leveraging existing public data using clinical bridging and …

Office of New Drug Quality Assessment Division of Pre-Marketing Assessment II Branch III CMC REVIEW OF NDA 22-204