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Zdrowie i gospodarka · 13.04.2023

Over-the-Counter Monograph Order Requests: Format and Content; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Over-the- Counter Monograph Order Requests (OMORs): Format and Content." This draft guidance provides recommendations on the format and content of the information that a requestor should provide in an over-the-counter (OTC) monograph order request (OMOR) and identifies relevant guidance documents to assist requestors in preparing their OMORs.

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