2022-23791: Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program." This guidance provides stakeholders with information regarding FDA's implementation of the Over-the-Counter Monograph Drug User Fee Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The agency’s own summary, as published.
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