Tag: Eskata

Eskata

Regulatory/FDA

Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

Aug. 5, 2019 – In two new Untitled Letters, the FDA’s Office of Prescription Drug Promotion (OPDP) makes clear that omitting risk information, misrepresenting product efficacy and using visuals that distract from risk messaging in direct-to-consumer (DTC) broadcast ads may draw the agency’s enforcement attention. In a July 25 Untitled Letter to CooperSurgical Inc., OPDP […]

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