FDA FIELD FORCE MANAGEMENT
This article was originally published in The Gold Sheet
Executive Summary
...is searching for ways to enhance the productivity of resources stretched thin by an expanding workload. The Team Biologics program is unfolding on schedule, meeting field management’s target of inspecting at least 50% of the team’s inventory, which now includes therapeutic biologics, in FY ‘99. Experience is being gained in the drug area on a handful of initiatives originally applied to medical devices including investigator certification, pre-announced inspections and annotated 483s. The inspection MRA with the EU is moving into the second year of a "transition" phase with key pieces of the puzzle not yet in place including the completion of a harmonized bulk drug GMP guideline, currently being developed through the ICH process.