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Five FDA news stories you may have missed
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In September, the FDA approved the first treatment for a rare pulmonary disease, issued warnings for patients, providers and manufacturers and stepped up its efforts to investigate the outbreak of lung injuries related to the use of electronic cigarettes.
Healio Pulmonology has compiled a list of stories about the FDA’s activities and efforts over the past month in the field of pulmonology.
Investigation into vaping-related lung injuries intensifies
As the number of confirmed and probable cases of lung injury associated with electronic cigarette use, or vaping, surges, CDC, FDA and state health departments have scaled up their joint investigation into identifying the cause of this outbreak. Read more
FDA warns breast cancer treatments may lead to rare but severe lung inflammation
The FDA issued a safety alert indicating that three drugs used to treat some patients with advanced breast cancer may cause rare but severe lung inflammation. Read more
FDA warns Juul about marketing practices
The FDA has issued a warning letter to Juul Labs for marketing its products as modified risk tobacco products, without an appropriate FDA order in effect, through labeling, advertising and other activities directed to consumers, including a presentation given to youth at a school. Read more
Novel system for PAH receives FDA breakthrough device designation
The FDA has granted breakthrough device designation to a therapeutic intravascular ultrasound system for patients with pulmonary artery hypertension. Read more
FDA approves nintedanib for systemic sclerosis-associated ILD
The FDA has approved nintedanib capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma. Read more