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  • Title: Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Final rule.
    Journal: Fed Regist; 1998 Nov 20; 63(224):64556-88. PubMed ID: 10339052.
    Abstract:
    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).
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