Zdrowie i gospodarka · 23.04.2001

Draft Guidance for Industry on Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Using FDA- Approved Patient Labeling in Consumer-Directed Print Advertisements." This draft guidance describes how sponsors can use certain FDA-approved patient labeling to fulfill the requirement that prescription drug and biological product advertisements directed toward consumers (DTC) in print media contain adequate risk disclosure. FDA does not intend to object to the use of certain FDA-approved patient labeling, reprinted exactly as approved, to fulfill the requirement that DTC print advertisements contain a brief summary of the product's risks.