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

New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence-graysheet: 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 receptive to the group’s critiques and recommendations, according to Chip Hance, an industry veteran who is co-leading an entrepreneurs work group focused on streamlining the FDA clinical trial process for devices.