Foradil Completes LABAs’ Exit From Risk Evaluation and Mitigation Strategies
Executive Summary
FDA says Novartis’ assessment of the long-acting beta agonist’s REMS, which consisted only of a communication plan, shows the “plan, and therefore the REMS, has met its goal.”
You may also be interested in...
FDA Supersizes Its Order For LABA Safety Studies
The trials, which follow a label change and new REMS, will encompass seven times the patients included in the studies submitted to FDA for approval.
MedGuide-Only REMS Will Be The Exception, Not The Norm, As FDA Relaxes Policy
"In most cases" a MedGuide would be included as part of a REMS only when elements to assure safe use are needed, the agency says in a draft guidance.
LABA Safety Studies, REMS Are Next Topics For Sponsors, FDA After Relabeling
Discussions about how best to study the safety of long-acting beta agonists are ready to resume now that FDA has issued a revised label for the drug class