201308 FDA指南：ANDA：原料药和制剂稳定性试验问答（中英文）
Guidance for Industry 行业指南
ANDAs: Stability Testing of Drug Substances and Products
Questions and Answers
ANDA：原料药和制剂稳定性试验问答
DRAFT GUIDANCE
指南草案
This guidance document is being distributed for comment purposes only. 本指南文件发布仅供讨论。
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments
to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Radhika Rajagopalan 240-276-8546.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
August 2013 Generics
Guidance for Industry
ANDAs: Stability Testing of Drug Substances and Products
Questions and Answers ANDA：原料药和制剂稳定性试验问答
Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Silver Spring, MD 20993
Phone: 301-796-3400; Fax: 301-847-8714
druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
August 2013
Generics Contains Nonbinding Recommendations Draft — Not for Implementation
2013.8-FDA指南：ANDA：原料药和制剂稳定性试验问答(中英文)
