Zdrowie i gospodarka · 28/01/1999
Draft Guidance for Industry on Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling.'' The draft guidance is intended to clarify for prescription drug manufacturers, relabelers, and distributors FDA's position regarding placing the therapeutic equivalence code on approved FDA product labels and labeling. It also provides recommendations on how to display therapeutic equivalence codes on labels and labeling. Inclusion of a therapeutic equivalence code on prescription drug labels/labeling is voluntary.