FDA 发布处方药使用相关软件监管考虑定稿指南

Regulatory Considerations for Prescription Drug Use-Related Software

AI 导读

FDA 发布《处方药使用相关软件监管考虑》定稿指南，将 2023 年 9 月 19 日发布的同名草案定稿。指南说明 FDA 如何把药品标签权限适用于药品申办者或其代表传播的特定软件输出，适用范围为与处方药或以处方药为主导的药械组合产品配合使用、且由 CDER 或 CBER 担任主导中心的产品。文件编号 FDA-2023-D-2482，指南可按 21 CFR 10.115(g)(5) 随时提交意见。

推荐理由

定稿指南说明 FDA 如何把药品标签权限适用于药企传播的特定软件输出，可供界定此类软件与标签的关系。

正文 · 原文

GUIDANCE DOCUMENT

Final Level 1 Guidance

Docket Number:

FDA-2023-D-2482

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Oncology Center of Excellence

Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Regulatory Considerations for Prescription Drug Use-Related Software.” This final guidance describes FDA’s application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center. This guidance finalizes the draft guidance of the same title issued on September 19, 2023.

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-2023-D-2482.