cross-labeled product
Glossaries
| Term | Definition |
|---|---|
| cross-labeled product |
An investigational drug, device, or biological product packaged separately that, according to its proposed labeling, is intended for use only with another investigational or approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect. NOTE: In the case where an approved product is combined with an investigational product, upon approval of the cross-labeled product the label of the previously approved product should be modified to reflect the combination status. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, co-packaged product.
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