CDRH Eyeing Drug Money, “True Dialogue” in User Fee Talks

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ARTICLE SUMMARY:

FDA device officials appear to be eyeing the big dollars tied to drug user fee programs with some envy, and other updates from the MDUFA V negotiations.

The device industry’s goal to keep FDA user fees close to current levels in the next round of the program (MDUFA V) is hitting a snag in early negotiation meetings with agency officials who are raising FDA drug user fees as a comparator.

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