Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Innovative Approaches for Nonprescription Drug Products." This draft guidance describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: The development of labeling in addition to the DFL and the implementation of additional conditions so that consumers appropriately self-select and use the product.