Conclusions While in the EU there seems to be a higher degree of use of disease modification and related terminology outside the context of the product label (consistent referencing to disease modification in therapeutic drug development guidelines and lay language description suggesting a disease-modifying treatment concept in the Package Leaflet of MS drugs), we observed a clear trend from both the FDA and EMA toward a non-acceptance of disease modification-related terminology—or any claims specifying the treatment concept—in the label indication sections of drugs to treat MS.
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