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Innovative Approaches for Nonprescription Drug Products July 2018


Not for implementation. Contains non-binding recommendations.

Innovative Approaches for Nonprescription Drug Products

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.