FDA’s Plaisier: GMP Oversight Must Shift To Outcomes Model
In an interview with “The Pink Sheet,” the Office of Regulatory Affairs chief says she wants to chart her office’s activities based on their effect on public health instead of simply counting outputs like the number of inspections or 483s.
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Number 2 pencils will not be required, but the U.S. FDA hopes manufacturing reports will make purchasing decisions resemble the college admissions process to some extent.
CDER’s Woodcock says the new database will drive risk-based inspection decisions.
The type of incentive remains under consideration, but one suggestion is a grading system similar to what restaurants receive from local health departments.