OGD Will First Review DMFs That Are Already Referenced in ANDAs to Manage Heavy Workload
This article was originally published in The Gold Sheet
Executive Summary
To help prioritize its heavy workload of “completeness assessments” for drug master files and to prevent possible filing delays with their associated ANDAs, FDA’s DMF review staff is reviewing those assessments for DMFs that are already referenced. Highest review priority is accorded to those DMFs referenced in expedited ANDAs for drugs that are in shortage.