New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence

20 May 2013

Variability runs high in FDA’s process for approving new device trials, but the agency is open to recommendations for improvements coming out of its entrepreneurs-in-residence program, says Chip Hance, a former Abbott executive participating in the program.

A group of outside experts working inside CDRH has pinpointed significant variability in how FDA approves new clinical trials and is proposing new agency metrics to improve the investigational device exemption process.

Efforts by participants in the device center’s entrepreneurs-in-residence program are still under way, but FDA officials have so far been...

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