Today, the US Food and Drug Administration (FDA) issued a draft guidance on Innovative Approaches for Nonprescription Drug Products. This 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: (1) the development of labeling in addition to the DFL, and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product. 

 

The appropriateness and specific details of either of these approaches will depend on the circumstances that apply to a particular drug product. These innovative approaches may be useful for applicants intending to develop and seek 26 approval of certain nonprescription drug products through the submission of a new drug application (NDA), including an application submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355).