Imaging Drugs Make Jump To Devices In New Decision By FDA
After losing the recent Genus Medical Technologies court case, the US FDA will begin transitioning certain imaging agent drugs to devices.
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User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.
The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.
The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.