title: Continued regulatory actions affecting the use of erythropoiesis-stimulating agents.
abstract: The FDA sent a "Complete Response and Safety Labeling Change Order" to the sponsors of ESAs on July 30, ordering changes to ESA labels in three important ways. For the first time, the FDA used its statutory authority to order a sponsor to make revisions to a product label.
authors.forename: Karen
authors.initials: K
authors.lastname: Hagerty