FDA发布单克隆抗体用作药品生产试剂的最终指南
Monoclonal Antibodies Used as Reagents in Drug Manufacturing
FDA发布最终指南，就单克隆抗体作为试剂用于CDER或CBER监管的原料药生产提出建议。指南聚焦新药申请、简化新药申请、生物制品许可申请及其补充申请或IND中应处理的CMC问题。意见可通过案卷编号FDA-2013-S-0610提交。
GUIDANCE DOCUMENT
Final
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance is intended to provide recommendations to sponsors and applicants on the use of monoclonal antibodies (mAbs) as reagents in the manufacture of drug substances that are regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The guidance focuses on the chemistry, manufacturing, and control (CMC) issues that should be addressed in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), supplements to these applications, or investigational new drug applications (INDs).
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov