FDA 发布 Q6B 生物技术及生物制品规格、检验程序与可接受标准最终指南
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
FDA 发布 Q6B 最终指南，就生物技术及生物制品的国际统一规格设定与论证提出一般性原则，以支持新上市申请。该文件编号为 FDA-1998-D-0003，由 CDER 与 CBER 发布。FDA 表示可随时通过线上或书面方式对该指南提交意见。
材料给出 Q6B 最终指南的适用范围，即生物技术及生物制品国际统一规格的设定与论证原则，并说明可随时提交意见。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-1998-D-0003
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This guidance document provides guidance on general principles for the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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 written comments should be identified with this document's docket number: FDA-1998-D-0003.
来源：FDA Pharmaceutical Quality Documents · fda.gov