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New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

 
• By Shawn M. Schmitt

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Capitol House

Two US senators have drafted a bill they say will bring more transparency and consistency to FDA device facility inspections.

Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced the legislation, S. 404, on Feb. 15. It calls...

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