FDA Unveils Draft Guidance for Cross-Labeling of Cancer Drugs
The FDA released a draft guidance on Thursday with proposed recommendations for making changes to the labeling of a previously approved oncology drug when it is used in a combination drug regimen.
The agency defines cross-labeling as the inclusion of information in product labeling of two or more oncology drugs approved together for a specific indication.
The intent of the draft guidance is to provide information in product labeling for the drugs used in a combination regimen that are “complementary and consistent,” and not to include all of the same information in labeling for each drug in the combination regimen, the agency said.
Comments on the draft are due by Jan. 19, 2021.