美国FDA 指导原则 提供电子格式的法规提交IND安全报告工业指南 英文原版.pdfVIP

Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Dockets Management Staff (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) Meredith Chuk at 301-796-2340 or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-402- 8010. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Oncology Center of Excellence (OCE) October 2019 Electronic Submissions ft.docx 10/08/19 Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor