Providing Over-the-Counter Monograph Submissions in Electronic Format

On 27 September 2022 the FDA published the draft guidance. Submit comments by 28 November 2022.

This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to assist submitters by describing the electronic OTC monograph submissions requirement in section 505G(j) of the FD&C Act and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format.

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