Metered-dose inhalers
This article was originally published in The Tan Sheet
Executive Summary
FDA's Generic Drugs Advisory Committee will discuss results of bioequivalence studies of metered-dose inhalers conducted by Johns Hopkins University on the first day of a meeting tentatively set for Sept. 14-15. FDA had hoped to bring the studies before the committee in June. On the second day, the committee will address issues related to documentation of bioequivalence for solution/device combinations. The meeting is expected to be held at the Potomac Inn in Rockville, Md.