2013-8FDA指南：ANDA：原料药和制剂稳定性试验问答中英文.doc

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for Industry?行业指南 ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 DRAFT GUIDANCE 指南草案 This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the?Federal Register?of the notice announcing the availability of the draft guidance.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?. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration,