美国FDA 指导原则 向疫苗研究和审查办公室提交疫苗研究数据集工业指南；技术规范文件 英文原版.pdfVIP

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review Guidance for Industry Technical Specifications Document This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). Submit one set of either electronic or written comments on this guidance at any time. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with docket number FDA- 2018-D-1216. Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@, or from the Internet at /vaccines-blood-biologics/guidance-compliance- regulatory-information-biologics/biologics-guidances. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research December 2019 Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review Guidance for Industry Technical Specifications Document Revision History Date Version Summary of Revisions April 2018 1.0 Initial Version October 2019 2.0