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In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says. Read More
The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More
Sponsors conducting clinical trials in India must fully inform study patients about potential payments resulting from adverse events during videotaped informed consent sessions, a draft guideline says. Read More