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

US FDA To Screen Rx Drug Launch Promos Prior To Initiating Review

Executive Summary

Office of Prescription Drug Promotion is adding a five-day screening period to its review of core prescription drug launch materials to determine if they are actually core promotions with all necessary information. Companies can decide whether to resubmit materials deemed non-core or have FDA go forward with a non-core launch review.

You may also be interested in...



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.

US FDA Actions On Rx Drug Promos Covered New Territory Last Year

Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.

US FDA Aims For More Timely Reviews Of Rx Drug Launch Promotions

New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS143329

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