Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Cross-labeling comments: AdvaMed proposes definitions for terms such as "combination technology," "individually specified" and "generally consistent labeling" in July 8 written FDL-1comments to FDA, which formalize oral remarks made on the trade association's behalf at a May 10 FDA/Drug Information Association workshop on cross-labeling (1"The Gray Sheet" May 16, 2005, p. 15). FDA guidance should specify the appropriate "roles and relationships" between device and drug firms with separately packaged products, where the device label identifies the drug to be used in combination. However, law changes are not necessary, the group contends...
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