US FDA Could Use More Foreign Investigators If It Could Find Them, Woodcock Says
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.
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US FDA officials grilled during first Senate Finance Committee hearing in months over practice of preannouncing foreign inspections.
'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.
Congressional oversight agency urges FDA to make better use of foreign offices with more effective performance measures and staffing goals; GAO notes agency’s progress towards risk-based inspections – and its plan to revisit every site at least once every five years.