Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease

In a response to FDA officials’ comment, the authors agree that the FDA struck an appropriate balance between evidence generation and patient access to lower-cost generics in the case of bioequivalence studies for fluticasone-salmeterol. Post-market studies using real-world data can help the FDA continue to promote the availability of generic inhalers and other drug-device combinations.