Providing Over-the-Counter Monograph Submissions in Electronic Format; Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Over-the-Counter Monograph Submissions in Electronic Format." This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. This guidance finalizes the draft guidance of the same title issued on September 28, 2022.
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