2022-21007: Providing Over-the-Counter Monograph Submissions in Electronic Format; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Providing Over-the-Counter Monograph Submissions in Electronic Format." This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The agency’s own summary, as published.
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