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This bill amends the Federal Food, Drug, and Cosmetic Act to create an expedited approval pathway for over-the-counter (nonprescription) drugs that meet certain criteria, such as treating novel indications, being new molecular entities, or containing active ingredients never before available without a prescription. The FDA would designate qualifying drugs as "priority nonprescription drugs" and provide expedited review, including dedicated project leads, collaborative meetings, and streamlined trial design. The bill requires the FDA to publish a list of conditions for which nonprescription drugs could provide meaningful public health benefit and to report to Congress on the program's outcomes within four years; the authority expires September 30, 2032.
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