Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

United States · Last verified: 2026-09-08

Number

21 CFR 99

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

关于已上市药品、生物制品和器械未批准/新用途信息的传播：规定制造商传播此类信息可提交的材料、FDA 处理、纠正措施与停止传播、以及记录保存要求。

Source: U.S. Food and Drug Administration (public domain)