Fed Regist. 1998 Nov 20;63(224):64556-88.
The Food and Drug Administration (FDA) is issuing final regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drugs, including biologics, and devices. The final rule describes the new use information that a manufacturer may disseminate and describes the content of and establishes procedures for a manufacturer's submission to FDA before it may begin disseminating information on the new use. The final rule also describes how manufacturers seeking to disseminate information on a new use must agree to submit a supplemental application for that use within a specified period of time, unless a supplemental application already has been submitted or FDA has exempted the manufacturer from the requirement to submit a supplement. The final rule provides for requests to extend the time period for submitting a supplemental application for a new use and describes how a manufacturer can seek an exemption from the requirement to submit a supplemental application for the new use. Additionally, the final rule discusses FDA actions in response to manufacturers' submissions, corrective actions that FDA may take or require, and recordkeeping and reporting requirements. The final rule implements sections 551 through 557 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa through 360aaa-6) as amended by section 401 of the Food and Drug Administration Modernization Act of 1997 (FDAMA).
美国食品药品监督管理局（FDA）正在发布最终法规，内容涉及已上市药品（包括生物制品）和器械的未批准用途（也称为“新用途”和“标签外用途”）信息的传播。最终规则描述了制造商可以传播的新用途信息，并描述了制造商在开始传播新用途信息之前向FDA提交的内容并确立了相关程序。最终规则还描述了寻求传播新用途信息的制造商必须如何同意在规定时间内就该用途提交补充申请，除非已经提交了补充申请或FDA已免除制造商提交补充申请的要求。最终规则规定了延长提交新用途补充申请期限的请求，并描述了制造商如何寻求免除提交新用途补充申请的要求。此外，最终规则讨论了FDA针对制造商提交材料的行动、FDA可能采取或要求采取的纠正措施以及记录保存和报告要求。最终规则实施了经1997年《食品药品管理局现代化法案》（FDAMA）第401条修订的《联邦食品、药品和化妆品法案》（该法案）（《美国法典》第21编第360aaa条至第360aaa - 6条）的第551条至第557条。
