A REMS by any Other Name
This article was originally published in RPM Report
Executive Summary
A new prescription drug for treatment of varicose veins clears FDA. The only dispute in the review: how to handle a remote but real risk of anaphylaxis. A REMS? Not this time…
You may also be interested in...
Making a Good First Impression: Launch Messages in an Era of REMS
When FDA took the unusual step of reprimanding a clinical investigator for promoting a newly approved botulinum toxin brand, the agency stressed its over-riding concern about the "first impression" of a new product in marketing messages Commercial sponsors should pay attention: just ask King.
FDAAA Impact (Year Two): More of Everything
The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation & Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing.
FDAAA Impact (Year Two): More of Everything
The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation & Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing.