FDA 发布实施 FDAMA 1997 年第 130 条的上市后研究承诺状态报告最终指南
Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
FDA 发布最终版 Level 1 指南，就提交已批准人用药品或经许可生物制品的上市后研究承诺状态报告给出程序、内容与格式建议。指南还说明 FDA 公开上市后研究承诺相关信息的义务，以及审评承诺最终报告的时间安排。文件编号为 FDA-1999-N-0098，公众可按 21 CFR 10.115(g)(5) 随时提交意见。
GUIDANCE DOCUMENT
Final Level 1 Guidance
- Docket Number:
- FDA-1999-N-0098
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The purpose of this guidance is to assist applicants in meeting the requirements of section 130 of the Food and Drug Administration Modernization Act of 1997. This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study commitment status report for an approved human drug or licensed biological product. This guidance also describes the FDA’s obligations to make certain information about postmarketing study commitments public, including the type of information that will be made public and the FDA’s time frames for reviewing postmarketing study commitment final reports.
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-1999-N-0098.
来源：FDA Pharmaceutical Quality Documents · fda.gov