Event

The most recent regulatory FDA actions including recent drug approvals for pulmonary diseases (asthma, COPD, cystic fibrosis) will be discussed. Safety issues including the Agency's review and decisions regarding the completed long-acting beta agonists (LABAs) safety studies in asthma, as well as the Agency's ongoing efforts regarding current risk/benefit assessment of opioid drugs (in pediatric populations) for cough will be presented. The current regulatory framework for combination drug development in COPD will be discussed.