DTC For Accelerated Approval Drugs: US FDA Is Taking Another Look At Disclosure On Websites
Study will assess responses of cancer survivors and caregivers to disclosures that a drug received accelerated approval. FDA analysis found that 73% of 26 accelerated approval drugs cited approval pathway on product websites.
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Over PhRMA’s Objections, US FDA To Study Accelerated Approval Disclosures in DTC Ads
PhRMA argued the study is duplicative of previous project and lacks practical utility. Agency says it is replicating the prior study in a new patient population and testing additional versions of accelerated approval disclosure. Agency makes minor revisions to the study questionnaire.
Despite Few Actions On Rx Drug Promos, US FDA Increased Engagement With Stakeholders Last Year
Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.