Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to issue new regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drug, including biologics, and devices. The proposal, which would implement the dissemination provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), would describe the content of and establish procedures for a manufacturer's submissions to FDA before it may begin disseminating information on the new use. The proposal also would describe how manufacturers seeking to disseminate new use information must agree to submit a supplement 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 proposal also would provide for requests to extend the time period for submitting a supplement for a new use, and it would describe how a manufacturer can seek an exemption from the requirement to submit a supplement. Additionally, the proposal would discuss FDA actions in response to manufacturer's submissions, corrective actions that FDA may take, and recordkeeping and reporting requirements.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D007255:Information Services / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration