FDA发布未获批ANDA原料药替代来源最终指南（2000年12月）
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs
FDA发布针对未获批ANDA中原料药替代来源的最终指南，说明仿制药办公室（OGD）对替代来源使用的政策。指南列出可以使用替代来源的情形，并称旨在减轻行业监管负担、为原料药来源在批准前后的变更提供更一致的处理方式。文件标注为2000年12月定稿，FDA说明可随时按21 CFR 10.115(g)(5)提交意见。
GUIDANCE DOCUMENT
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs Guidance for Industry December 2000
Final
- Docket Number:
- None found
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to describe the Office of Generic Drugs' (OGD) policy on the use of alternate sources of the active pharmaceutical ingredients (API) in unapproved abbreviated new drug applications (ANDAs). The guidance describes the circumstances under which an alternate source can be used. This guidance is intended to decrease the regulatory burden on industry and provide a more consistent approach to pre- and postapproval changes in API sources.
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: None found.
来源：FDA Pharmaceutical Quality Documents · fda.gov