US FDA: Richtlijnen promotionele etiketten voor medicijnen

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.”
This revised draft guidance, when finalized, will assist manufacturers, packers, and distributors of human prescription drugs and biologics with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers (FDA, 9 februari 2015).
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