Tag: OPDP Guidance

OPDP Guidance

DTC Advertising

OPDP Guidance on Presenting Risk, Efficacy Info in DTC Ads Calls for Consumer-friendly Approaches

OPDP Guidance on Presenting Risk, Efficacy Info in DTC Ads Calls for Consumer-friendly Approaches

Oct. 19, 2018 – It is important for drug companies to make quantitative presentations of risk or efficacy information in direct-to-consumer (DTC) ads more consumer friendly, according to draft guidance issued by the FDA’s Office of Prescription Drug Promotion (OPDP). The draft guidance, “Presenting Quantitative Efficacy and Risk Information in [DTC] Promotional Labeling and Advertisements,” […]

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