FDA Updates DTC Ad Policy on Risk Information

Tuesday, February 17, 2015

Source: MM&M

FDA has posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect “recent social science research.”

Entitled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, the new document updates prior agency policy and describes the brief summary requirement.

The document recommends that firms not disseminate the full FDA-approved package insert (PI) to fulfill the adequate directions for use requirement for consumer-directed print promotional labeling.

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