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# Oncology Drug Cross Labeling Guidance
- URL: https://www.fdaweb.com/oncology-drug-cross-labeling-guidance-2/
- Published: 2022-11-02T12:00:00.000Z
- Updated: 2026-09-14T18:05:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153108

FDA has published a guidance, *Cross Labeling Oncology Drugs in Combination Regimen*, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of the drugs. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cross-labeling-oncology-drugs-combination-regimens-guidance-industry?ref=fdaweb.com) says a combination regimen refers to two or more drugs that are marketed separately, where at least one of the drugs has an approved indication for the combination based on one or more adequate and well-controlled clinical trials. Cross-labeling is defined in the guidance as the inclusion of information in the approved labeling of two or more oncology drug products approved in a combination regimen for a specific indication.

The guidance does not address all issues that might arise relating to labeling for oncology drugs for use in a combination regimen, the guidance says. It also does not address circumstances in which a drug product and a biological product packaged separately constitute a cross-labeled combination product.