June 13, 2022 – From a staff reorganization to a monthly newsletter to increased collaborations with stakeholders, in 2022 the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) – under the direction of Dr. Catherine “Katie” Gray – has made a series of organizational and communications moves to make OPDP both more transparent […]
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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, […]
Read moreFeb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version that covers brief summary requirements for consumer-directed print drug ads by calling for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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