FDA 发布给药器械与组合产品给药性能要点指南草案
Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products
FDA 发布指南草案，说明用于递送人用药品（含生物制品）的器械及含器械部件的组合产品在给药性能方面需提交的核心信息。文件标注为草案、不供实施，属非约束性建议，覆盖研究性申请、上市申请及上市后变更申请中的信息与数据。征求意见文件编号为 FDA-2024-D-2560，可随时在线或书面提交意见。
材料说明该草案聚焦给药器械及含器械部件组合产品的给药性能资料，并列出研究、上市及上市后变更申请需提交的数据范围。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2024-D-2560
- Issued by:
-
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product. The guidance describes FDA’s recommendations related to information that is essential for establishing and assessing drug delivery performance and focuses on recommendations for the information and data to submit in investigational, marketing, and post-market change applications.
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-2024-D-2560.
Questions?
来源：FDA 官方药品与生物制品信息 · fda.gov