Botanical Drug development2015FDA植物药研发行业指南(草案)(中英对译稿).pdf

Contains Nonbinding Recommendations Draft — Not for Implementation 包含不具约束力的建议 草案 — 不用于实施 Botanical Drug Development Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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, 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) Sau L. Lee at sau.lee@ 301-796-2905, or Rajiv Agarwal at rajiv.agarwal@ 301- 796-1322. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2015 Pharmaceutical Quality/CMC Revision 1 北京大学药物信息与工程研究中心 comments@    i    Contains Nonbinding Recommendations Draft — Not for Implementation