Dry powder inhaler flow rate performance studies being suggested by FDA, especially for newer devices.
Executive Summary
DRY POWDER INHALER FLOW RATE PERFORMANCE STUDIES are being suggested by FDA, especially for newer inhaler designs, Division of Pulmonary Drug Products Medical Officer Babatunde Otulana, MD, said at a Jan. 14 Drug Information Association meeting on DPIs in Washington D.C. The studies suggested by Otulana are in addition to the studies outlined in FDA's 1994 Points to Consider on Dry Powder Inhalers ("The Pink Sheet" July 18, 1994, T&G-4).