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...
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.
Woodcock Faces Maze Of Rules To Become Commissioner Nominee
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: