Zdrowie i gospodarka · 11/2/2022
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program."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).