Issue Date: July 18, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Draft
Innovative Approaches for Nonprescription Drug Products
This guidance describes two innovative approaches that may be useful to consider for 16 demonstrating safety and effectiveness for a nonprescription drug product in cases where the 17 drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used 18 safely and effectively in a nonprescription setting: (1) the development of labeling in addition to 19 the DFL, and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product.
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