GUIDANCE DOCUMENT
Innovative Approaches for Nonprescription Drug Products July 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2018-D-2281
- Issued by:
-
Guidance Issuing OfficeCenter 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.
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All written comments should be identified with this document's docket number: FDA-2018-D-2281.