FDA《已许可生物制品合作生产安排》行业指南（2008年11月终版，FDA-1999-D-0128）
Cooperative Manufacturing Arrangements for Licensed Biologics
FDA生物制品评价与研究中心（CBER）与药品评价与研究中心（CDER）发布《已许可生物制品合作生产安排》行业指南终版，文件编号FDA-1999-D-0128，日期为2008年11月。指南针对生物制品生产高度专业化、企业仅承担部分生产环节的现状，说明合作生产安排有助于促进产品开发与生产灵活性。公众可随时按21 CFR 10.115(g)(5)提交意见。
GUIDANCE DOCUMENT
Cooperative Manufacturing Arrangements for Licensed Biologics Guidance for Industry November 2008
Final
- Docket Number:
- FDA-1999-D-0128
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
The development of complex and highly specialized technology and equipment for the manufacture of biological products has fostered the emergence of many companies that perform only limited aspects of manufacturing processes. Consequently, many manufacturers are interested in sharing or contracting parts of manufacturing in order to facilitate product development and manufacturing flexibility. Cooperative manufacturing arrangements enhance the development of new products.
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-1999-D-0128.
Questions?
来源：FDA Pharmaceutical Quality Documents · fda.gov