FDA Scales Back LABA Safety Relabeling To Address Physician Worries
Executive Summary
FDA has modified the safety relabeling it is rolling out for long-acting beta agonists to reflect physician concerns that an abrupt discontinuation of the products could be harmful to patients
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.
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.
LABA Label Changes Could Reinvigorate Single-Ingredient Products
FDA's new labeling and use guidelines for long-acting beta agonists may present some sales challenges, but also may create a new market for older drugs