Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

DTC For Accelerated Approval Drugs: US FDA Is Taking Another Look At Disclosure On Websites

Executive Summary

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.

You may also be interested in...



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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS144461

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel