INHALATIONAL DRUG R&D POINTS-TO-CONSIDER PREVIEW
Executive Summary
INHALATIONAL DRUG R&D POINTS-TO-CONSIDER PREVIEW to FDA's Pulmonary-Allergy Advisory Committee July 14 outlines trials the agency suggests would aid in the approval of new metered-dose inhaler products, crossover studies for products making the switch from chlorofluorocarbon-based propellants to other delivery systems and the trials needed for approval of dry powder and pediatric formulations. Still in development, the agency's Points to Consider for Clinical Development of Metered-Dose Inhalers and Dry Powder Inhalers was presented by Pulmonary-Oncology Division Medical Reviewer Babatunde Otulana, MD.