FDA Releases Draft Device User Fee Agreement
The agreement could land the FDA almost $20bn in user fees between 2023 and 2027.
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The deal includes a $110m Total Product Lifecycle Advisory Program pushed for by the US agency, but also credits unused funds past a certain threshold back to industry.
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.
A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion