Alternatives To Brief Summary Outlined In Draft Guidance
This article was originally published in The Pink Sheet Daily
Executive SummaryOne of FDA's three draft guidances on DTC advertising requests that consumer-friendly language be used. Commissioner McClellan calls proposed brief summary alternatives a "win-win" and suggests manufacturers will be able to reduce their advertising costs as a result.
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FDA’s revised draft guidance for disclosing risk information in direct-to-consumer print ads advises against the use of package insert information in the brief summary; suggests Drugs Facts box or Q&A as alternative formats.