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Zdrowie i gospodarka · 21.09.2021

Final Administrative Orders for Over-the-Counter Monographs; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of certain final administrative orders (final orders), including for over-the-counter (OTC) drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is also announcing the process for making these final orders available. Finally, FDA is announcing its plan for withdrawing regulations that established final OTC drug monographs prior to the passage of the CARES act, and withdrawing or making technical changes to the procedures governing the OTC drug review.

Source: Federal Register — Food and Drug AdministrationOpen original release →