FDA: Shift Back to Generalist Inspectorate
As part of its newly announced “Simple Reform” initiative, the U.S. FDA intends to move away from its current specialisation model and re-establish generalist inspector teams.
The approach aims to increase inspector flexibility, help address staffing challenges, and strengthen domestic manufacturing oversight. The change would reverse key elements of the agency’s 2017 Program Alignment Initiative designed to ensure agency inspectors were specialised to the commodity areas they covered.
However, industry experts warn that the broad competencies required for complex areas such as biotechnology and cell-based therapies may challenge the effectiveness of a generalist model.
Source:
Citeline Podcasts: Drug Fix: Another FDA Inspection Reorg, Industry Navigating New DTC Landscape
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