Foradil Completes LABAs’ Exit From Risk Evaluation and Mitigation Strategies
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.”
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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.
"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a MedGuide would be included as part of a REMS only when elements to assure safe use are needed, the agency says in a draft guidance.
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