US FDA: Promotional labeling for human prescription drugs
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional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This revised draft guidance, when finalized, will assist manufacturers, packers, and distributors of human prescription drugs and biologics with meeting the brief summary requirement for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 February 2015).
Click here for the full FDA notice.
If you have any questions about this subject, please contact us: info@nvc.nl, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.