FDA 修订发布 IND 与 BA/BE 研究安全性报告要求小企业合规指南
Safety Reporting Requirements for INDs and BA/BE Studies
FDA 发布面向小企业的合规指南最终版，帮助其理解并遵守 IND 及豁免 IND 的 BA/BE 人体药物与生物制品研究的加快安全性报告要求。文件编号 FDA-2010-D-0482，由 CBER 与 CDER 发布，标注为 2026 年 10 月版，并对原有安全性报告指南信息作了更新。
SMALL ENTITY COMPLIANCE GUIDE
Safety Reporting Requirements for INDs and BA/BE Studies Guidance for Industry and Investigators October 2026
Final
- Docket Number:
- FDA-2010-D-0482
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This guidance is intended to help small businesses understand and comply with FDA’s expedited safety reporting regulations for human drug and biological products that are being investigated under an investigational new drug application (IND) or as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements. FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This revision updates information about FDA guidance on safety reporting requirements for INDs and IND-exempt BA/BE studies.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0482.
来源：FDA 官方药品与生物制品信息 · fda.gov