Tag: brief summary

brief summary

Regulatory/FDA

FDA Studying Extent of Risk Information in DTC Print Ads

FDA Studying Extent of Risk Information in DTC Print Ads

Aug. 20, 2018 – The FDA continues to consider whether the amount and location of risk disclosure information currently appearing in direct-to-consumer (DTC) print ads – both in the brief summary and the “important safety information” (ISI) section – has the potential to “overwarn” consumers. In an FDA notice in the Federal Register last week, […]

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Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version that covers brief summary requirements for consumer-directed print drug ads by calling for standardized formats that are easier for consumers to read and understand and recommending that drug firms do not disseminate the full, FDA-approved […]

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