Skip to main content

Interleukin-1/-6 Inhibitors & Interstitial Lung Disease and Pulmonary Arterial Hypertension

    Basic Details
    Status
    Complete
    Last Updated
    Monday, December 3, 2018
    Health Outcome(s)
    interstitial lung disease
    pulmonary arterial hypertension
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Regulatory Determination / Use

    Feasibility assessment of ARIA to conduct a postmarket safety study. FDA decided that no action is necessary at this time, based on available information.