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Zdrowie i gospodarka · 10.02.2004

Draft Guidance for Industry on Time and Extent Applications; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Time and Extent Applications." This guidance is being written to assist those persons interested in adding a new condition to the over-the-counter (OTC) drug monograph system. A time and extent application (TEA) can be submitted for FDA to determine whether a condition is eligible to be considered for inclusion in an OTC drug monograph. This guidance is designed to clarify issues concerning the TEA in an effort to facilitate the application process.

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