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Regulatory/FDA

OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

Sept. 9, 2019 – In its first Warning Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP), continues to call out the omission of risk information cited in previous Untitled Letters this year, stating that Metuchen Pharmaceuticals LLC’s direct-to-consumer (DTC) print ad and display banners for its erectile dysfunction (ED) drug include claims […]

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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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