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# Draft Guide on New Approaches for OTC Drugs
- URL: https://www.fdaweb.com/draft-guide-on-new-approaches-for-otc-drugs/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141907

*Federal Register* notice: FDA has made available a draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The document describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-18/pdf/2018-15296.pdf?ref=fdaweb.com).