DTC Ad Risk Disclosures Could Be Limited To ‘Serious And Actionable’
Despite PhRMA’s concerns, FDA is proceeding with a study using modified versions of existing TV ads, but agency will revise study questions to focus on value of the ‘major statement’ and not other aspects of ads.
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Viewers retain more risks and benefits in DTC ads showing only limited risk information, but experts predict it may not result in substantial change right away.
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.
Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.