Diagnostic Enternal Cholecystographic Radiopaque Human Prescription Drugs - Class Labeling Guideline for Professional Labeling

摘要

The Food and Drug Administration (FDA) announces the availability of a class labeling guideline for the professional labeling of diagnostic enteral cholecystographic radiopaque agents. Class labeling is appropriate for these products because they are all closely related in chemical structure, pharmacology, therapeutic activity, and adverse reactions. The guideline is intended to promote the use of identical professional labeling for each member of the diagnostic enteral cholecystographic radiopaque drug class.