Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Time and Extent Applications for Nonprescription Drug Products." This guidance describes a two-step process on how to request that a new condition be added to the over-the-counter (OTC) drug monograph system. The process includes submitting a time and extent application (TEA) to determine whether a condition is eligible for inclusion in the OTC drug monograph system and, if the condition is found to be eligible, submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled "Time and Extent Applications" published in the Federal Register on February 10, 2004 (69 FR 6309).